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Prezcobix Darunavir Ethanolate and Cobicistat 800 mg; 150 mg Tablet, Film Coated, 30-count — NDC 59676-0575-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Prezcobix Darunavir Ethanolate and Cobicistat 800 mg; 150 mg Tablet, Film Coated, 30-count — NDC 59676-575-30 (Billing 59676-0575-30)

by Janssen Products, LP · 30 TABLET, FILM COATED in 1 BOTTLE

This is a package of 30 tablets of Prezcobix Darunavir Ethanolate and Cobicistat 800 mg; 150 mg Tablet, Film Coated from Janssen Products, LP, marketed since Jan 2015 and currently FDA-listed; retail pharmacies pay about $79.99 per tablet (NADAC). It is this product's only package size.

NDC 59676-0575-30
🏷️ FDA NDC (as labeled) 59676-575-30 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 59676-575-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59676 labeler · 575 product · 30 package
Package marketed since
Jan 31, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
30 EA per package
Barcode (UPC)
0359676575306
Medicaid fills, this package
30,573 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59676-575-30
Product NDC 59676-575
11-digit billing NDC 59676057530
NCPDP billing unit EA — each (per item)
RxCUI 1600704, 1600710, 2710424, 2710426, 2738995, 2738999
UNII LW2E03M5PG, 33O78XF0BW
UPC 0359676575306
Application # NDA205395
SPL Set ID 9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f
Established class (EPC) Cytochrome P450 3A Inhibitor
Mechanism of action Cytochrome P450 3A Inhibitors; P-Glycoprotein Inhibitors; Cytochrome P450 2D6 Inhibitors; Organic Anion Transporting Polypeptide 1B1 Inhibitors; Organic Anion Transporting Polypeptide 1B3 Inhibitors; Breast Cancer Resistance Protein Inhibitors; Multidrug and Toxin Extrusion Transporter 1 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-01-31
Route ORAL
Dosage form TABLET, FILM COATED
Substance DARUNAVIR ETHANOLATE; COBICISTAT

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 073052
GCN 37367
HICL code 041531
Ingredient (HICL) Darunavir/Cobicistat
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5P
Therapeutic class — specific (HIC3) Antivirals, Hiv-Spec, Non-Peptidic Protease Inhib
AHFS code 08:18.08.08
AHFS class Hiv Protease Inhibitor Antiretrovirals
FDB label name PREZCOBIX 800 MG-150 MG TABLET
FDB brand name Prezcobix
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 073052
  • GCN: 37367
  • HICL (First Databank): 041531
  • AHFS class code: 08:18.08.08
  • RxCUI (RxNorm): 1600704
Why two NDCs? The FDA registers this code as 59676-575-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59676-0575-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cytochrome P450 3A Inhibitor class.

Pharmacologic class Cytochrome P450 3A Inhibitor
Drug family (ATC) Other therapeutic products
How it works Cytochrome P450 2D6 Inhibitors, P-Glycoprotein Inhibitors, Organic Anion Transporting Polypeptide 1B1 Inhibitors, Organic Anion Transporting Polypeptide 1B3 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PREZCOBIX 800 MG-150 MG TABLET Ingredient Darunavir/Cobicistat
📖 What it is MedlinePlus · NLM

The combination of darunavir and cobicistat is used to treat human immunodeficiency virus (HIV) infection. Darunavir is in a class of medications called protease inhibitors. It works by decreasing the amount of HIV in the blood. Cobicistat is in a class of medications called pharmacokinetic boosters. It works by increasing the amount of darunavir in the body so that it can have an increased effect. Although darunavir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications and making other lifesty...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Prezcobix and Prezcobix Ped work by blocking a key enzyme HIV needs to make new copies of itself. Darunavir is the active antiviral, and cobicistat is added to keep darunavir at ef...
  • What exactly does this medicine do for HIV?
  • Yes — this is one of the most important rules with Prezcobix and Prezcobix Ped. Taking darunavir without food can cut how much of it your body absorbs by nearly half. It doesn't ha...
  • Do I really have to take this with food every time?
📖 Read our full Darunavir and Cobicistat guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $79.994 $2,399.81 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $79.70 $2,390.91 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $78.59 $2,357.62 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Jan 2024 Apr 2026 Sep 2026 $80.000 $68.019
▲ Up 18% over the last 15 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
59676-0575-30 You're viewing this Main listing 30 TABLET, FILM COATED in 1 BOTTLE 2015-01-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Prezcobix 800 mg/1; 150 mgthis 59676-0575-30 Janssen 30 tablets $79.994 — Availability likely —
Prezcobix 800 mg/1; 150 mg 50090-1723-00 A-S 30 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
First FDA approval
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2032
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 21, 2025 RLD RS ⏳ ~6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8148374 — drug substance (U-1279)
US 8148374 — drug substance (U-4162)
US 8148374 — drug substance (U-4162)
US 8148374 — drug substance (U-2939)
US 7700645 — drug substance
US 10039718 — drug product
US 7700645 — drug substance
US 10039718 — drug product
US 7700645*PED — drug product
US 7700645*PED — drug product
2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (10)
PatentTypeUse codeExpires
US 8148374 ↗ Drug substance U-1279 Sep 3, 2029
US 8148374 ↗ Drug substance U-4162 Sep 3, 2029
US 8148374 ↗ Drug substance U-4162 Sep 3, 2029
US 8148374 ↗ Drug substance U-2939 Sep 3, 2029
US 7700645 ↗ Drug substance — Dec 26, 2026
US 10039718 ↗ Drug product — Oct 6, 2032
US 7700645 ↗ Drug substance — Dec 26, 2026
US 10039718 ↗ Drug product — Oct 6, 2032
US 7700645*PED ↗ Drug product — Jun 26, 2027
US 7700645*PED ↗ Drug product — Jun 26, 2027
Common questions
Is there a generic version of PREZCOBIX 800 MG-150 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for PREZCOBIX 800 MG-150 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2032 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Pink / green / Purple
ShapeOval
Imprint690;TG
Size21 mm
ScoringNot scored
FlavorStrawberry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Darunavir and Cobicistat inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerJanssen Products, LP
Application holderJANSSEN PRODUCTS LP
FDA applicationNDA205395 (NDA)
Labeler code59676
First marketedJan 2015
Product typeHuman Prescription Drug
Portfolio17 products on file

More NDCs from Janssen Products, LP labeler code 59676

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 139 words ▾

1 INDICATIONS AND USAGE PREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) [see Use in Specific Populations (8.4) and Clinical Studies (14) ] . PREZCOBIX and PREZCOBIX PED are a two-drug combination of darunavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor, and are indicated for the treatment of HIV-1 in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage: Adults and pediatric patients weighing at least 40 kg: One 800 mg/150 mg tablet taken once daily with food. ( 2.1 , 2.2 ) Pediatric patients weighing at least 25 kg to less than 40 kg: One 675 mg/150 mg tablet taken once daily with food. ( 2.1 , 2.2 ) Pediatric patients 3 years of age and older weighing at least 15 kg to less than 25 kg: One 600 mg/90 mg tablet for oral suspension taken once daily with food.

PREZCOBIX PED must be dispersed in drinking water and taken immediately with food. ( 2.2 , 2.3 ) Testing Prior to Initiation: HIV genotypic testing is recommended for antiretroviral treatment experienced patients. Assess estimated creatinine clearance in all patients prior to starting PREZCOBIX or PREZCOBIX PED.

When used with tenofovir disoproxil fumarate (TDF): Assess urine glucose and urine protein at baseline and monitor creatinine clearance, urine glucose, and urine protein. Monitor serum phosphorus in patients with or at risk for renal impairment. ( 2.5 )

2.1Overview of Different Dosage Forms Two different dosage forms are available: PREZCOBIX Tablets: 800 mg/150 mg film-coated tablets for adults and pediatric patients weighing at least 40 kg. 675 mg/150 mg film-coated tablets for pediatric patients weighing at least 25 kg to less than 40 kg. PREZCOBIX PED Tablets for Oral Suspension: 600 mg/90 mg film-coated tablet for oral suspension for pediatric patients aged 3 years and older weighing at least 15 kg to less than 25 kg [see Dosage and Administration (2.2 , 2.3) ] .

2.2Recommended Dosage in Adults and Pediatrics 3 Years of Age and Older Weighing at Least 15 kg The recommended dosages for adults and pediatric patients weighing at least 15 kg are shown in Table 1. The pediatric dose is based on weight. PREZCOBIX and PREZCOBIX PED are taken orally with food once daily in conjunction with other antiretroviral agents.

Table 1: Recommended Dosages of PREZCOBIX and PREZCOBIX PED in Adults and Pediatric Patients Weighing at Least 15 kg, who are Treatment-Naïve or Treatment-Experienced Without DRV RAMs DRV-resistance-associated mutations (RAMs): V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V. Patient Population Total Daily Dose Adults and pediatric patients weighing at least 40 kg One PREZCOBIX 800 mg darunavir/150 mg cobicistat tablet Pediatric Patients weighing at least 25 kg to less than 40 kg One PREZCOBIX 675 mg darunavir/150 mg cobicistat tablet Pediatric Patients aged 3 years and older weighing at least 15 kg to less than 25 kg One PREZCOBIX PED 600 mg darunavir/90 mg cobicistat tablet for oral suspension Before prescribing PREZCOBIX 675 mg/150 mg tablets, children should be assessed for the ability to swallow tablets.

For patients unable to swallow the 675 mg/150 mg tablet whole, the scored tablet may be split by hand into two pieces. Each piece should be consumed immediately after splitting to ensure the entire dose is administered. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

2.3Preparation and Administration Instructions for PREZCOBIX PED Advise patients or caregivers of patients taking PREZCOBIX PED to refer to the Instructions for Use to properly prepare and take the medication. PREZCOBIX PED must be dispersed in drinking water and taken immediately as described below. If not taken immediately, then the oral suspension should be discarded, and a new dose of medicine should be prepared.

The patient should not crush, chew or swallow the PREZCOBIX PED tablet for oral suspension. The following instructions should be followed: Place the tablet for oral suspension in a cup, add 30 mL (2 tablespoons) of non-carbonated room temperature drinking water. Stir well with a spoon until the tablet is completely dispersed.

The prepared medicine will appear reddish purple. Take all the prepared medicine immediately or to aid in administration, the prepared medicine can be further diluted with 10 mL (… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 150 words ▾

3 DOSAGE FORMS AND STRENGTHS PREZCOBIX Tablets: 800 mg/150 mg as pink, oval-shaped, film-coated tablet debossed with "800" on one side and "TG" on the other side containing 800 mg of darunavir and 150 mg of cobicistat. 675 mg/150 mg as green to dark green, oval-shaped, scored film-coated tablet debossed with "675" on one side and "TG" on the other side containing 675 mg of darunavir and 150 mg of cobicistat. PREZCOBIX PED Tablets for Oral Suspension: 600 mg/90 mg as reddish purple, oval-shaped, film-coated tablet debossed with "690" on one side and "TG" on the other side containing 600 mg of darunavir and 90 mg of cobicistat.

Tablets: 800 mg of darunavir and 150 mg of cobicistat. ( 3 ) Tablets: 675 mg of darunavir and 150 mg of cobicistat. ( 3 ) Tablets for oral suspension: 600 mg of darunavir and 90 mg of cobicistat.

( 3 )

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Darunavir and cobicistat are both inhibitors of the cytochrome P450 3A (CYP3A) isoform. PREZCOBIX should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which increased plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). Darunavir and cobicistat are both substrates of the cytochrome P450 3A (CYP3A) isoform.

Co-administration of PREZCOBIX or PREZCOBIX PED with CYP3A inducers may lead to lower exposures of darunavir and cobicistat and potential loss of efficacy of darunavir and possible resistance. Examples of drugs that are contraindicated for co-administration with PREZCOBIX or PREZCOBIX PED [see Drug Interactions (7.3 ) and Clinical Pharmacology (12.3) ] are listed below. Alpha 1-adrenoreceptor antagonist: alfuzosin Anticonvulsants: carbamazepine, phenobarbital, phenytoin Anti-gout: colchicine, in patients with renal and/or hepatic impairment Antimycobacterial: rifampin Antipsychotics: lurasidone, pimozide Cardiac Disorders: dronedarone, ivabradine, ranolazine Ergot derivatives, e.g. dihydroergotamine, ergotamine, methylergonovine Herbal product: St.

John's wort ( Hypericum perforatum ) Hepatitis C direct acting antiviral: elbasvir/grazoprevir Lipid modifying agents: lomitapide, lovastatin, simvastatin Opioid Antagonist: naloxegol PDE-5 inhibitor: sildenafil when used for treatment of pulmonary arterial hypertension Sedatives/hypnotics: orally administered midazolam, triazolam PREZCOBIX or PREZCOBIX PED is contraindicated in patients receiving certain co-administered drugs for which altered plasma concentrations are associated with serious and/or life-threatening events or loss of therapeutic effect.

( 4 , 7.2 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis), liver injury, including some fatalities can occur with PREZCOBIX or PREZCOBIX PED. Monitor liver function before and during therapy, especially in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases. ( 5.1 ) Skin reactions ranging from mild to severe, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms and acute generalized exanthematous pustulosis, can occur with PREZCOBIX or PREZCOBIX PED.

Discontinue treatment if severe reaction develops. ( 5.2 ) When PREZCOBIX or PREZCOBIX PED is used in combination with a TDF containing regimen, cases of acute renal failure and Fanconi syndrome have been reported. ( 5.4 ) PREZCOBIX or PREZCOBIX PED is not recommended in combination with other antiretroviral drugs that require pharmacokinetic boosting.

( 5.6 ) Monitor in patients with a known sulfonamide allergy. ( 5.7 ) Patients receiving PREZCOBIX or PREZCOBIX PED may develop new onset or exacerbations of diabetes mellitus/hyperglycemia ( 5.8 ), redistribution/accumulation of body fat ( 5.9 ), and immune reconstitution syndrome. ( 5.10 ) Patients with hemophilia may develop increased bleeding events.

( 5.11 )

5.1Hepatotoxicity During the darunavir clinical development program (N=3063), where darunavir was co-administered with ritonavir 100 mg once or twice daily, drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) was reported in 0.5% of participants. Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities including severe hepatic adverse reactions. Post-marketing cases of liver injury, including some fatalities, have also been reported with darunavir co-administered with ritonavir.

These have generally occurred in patients with advanced HIV-1 disease taking multiple concomitant medications, having co-morbidities including hepatitis B or C co-infection, and/or developing immune reconstitution syndrome. A causal relationship with darunavir co-administered with ritonavir has not been established. Appropriate laboratory testing should be conducted prior to initiating therapy with PREZCOBIX or PREZCOBIX PED and patients should be monitored during treatment.

Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of PREZCOBIX or PREZCOBIX PED treatment. Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZCOBIX or PREZCOBIX PED should prompt consideration of interruption or discontinuation of treatment.

5.2Severe Skin Reactions During the darunavir clinical development program (n=3063), where darunavir was co-administered with ritonavir 100 mg once or twice daily, severe skin reactions, accompanied by fever and/or elevations of transaminases in some cases, was reported in 0.4% of participants. Stevens-Johnson Syndrome was rarely (less than 0.1%) reported during the clinical development program. During post-marketing experience toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis have been reported.

Discontinue PREZCOBIX or PREZCOBIX PED immediately if signs or symptoms of severe skin reactions develop. These can include but are not limited to severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia. Mild-to-moderate rash was also reported and often occurred within the first four weeks of treatment and res… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Hepatotoxicity [see Warnings and Precautions (5.1) ] Severe skin reactions [see Warnings and Precautions (5.2) ] Effects on serum creatinine [see Warnings and Precautions (5.3) ] New onset or worsening renal impairment when used with tenofovir DF [see Warnings and Precautions (5.4) ] Immune Reconstitution Syndrome [see Warnings and Precautions (5.10) ] The most common adverse reactions to darunavir, a component of PREZCOBIX or PREZCOBIX PED (incidence greater than or equal to 5%) of at least moderate severity (greater than or equal to Grade 2) were diarrhea, nausea, rash, headache, abdominal pain, and vomiting.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trials in Adults During the darunavir clinical development program, where darunavir was co-administered with ritonavir 100 mg once or twice daily, the most common clinical adverse reactions (incidence greater than or equal to 5%) of at least moderate intensity (greater than or equal to Grade 2) were diarrhea, nausea, rash, headache, abdominal pain, and vomiting.

See the darunavir full prescribing information for additional information on adverse reactions reported with darunavir co-administered with ritonavir. See cobicistat full prescribing information for clinical trial information on adverse reactions reported with cobicistat. One single arm clinical trial was conducted with darunavir and cobicistat administered as single entities in 313 participants with HIV-1.

Adverse reactions evaluated through Week 24 did not differ substantially from those reported in clinical trials with darunavir co-administered with ritonavir. Clinical Trials in Pediatrics No clinical trials with PREZCOBIX and PREZCOBIX PED were performed in pediatric participants. However, the safety of the components of PREZCOBIX, darunavir and cobicistat, co-administered with two nucleoside reverse transcriptase inhibitors, was evaluated through clinical trial GS-US-216-0128 in virologically-suppressed pediatric participants of 12 to less than 18 years of age with weight ≥40 kg (Cohort 1, N=7), pediatric participants 6 to less than 12 years of age with weight ≥25 kg to <40 kg (Cohort 2, N=8) and pediatric participants aged ≥3 years with weight ≥15 kg to <25 kg (Cohort 3, N=11) through Week 48.

Safety analyses of this trial in these pediatric participants did not identify new safety concerns compared to the known safety profile of PREZCOBIX in adult participants [see Clinical Studies (14.2) ] .

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of darunavir. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Metabolism and Nutrition Disorders Redistribution of body fat Musculoskeletal and Connective Tissue Disorders Rhabdomyolysis (associated with co-administration with HMG-CoA reductase inhibitors) Renal and Urinary Disorders Crystal nephropathy, crystalluria Skin and Subcutaneous Tissue Disorders Toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms [see Warnings and Precautions (5.2) ] .

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Co-administration of PREZCOBIX or PREZCOBIX PED with other drugs can alter the concentration of other drugs and other drugs may alter the concentrations of darunavir or cobicistat. Consult the full prescribing information prior to and during treatment for potential drug interactions. ( 4 , 5.6 , 7 , 12.3 )

7.1Potential for PREZCOBIX or PREZCOBIX PED to Affect Other Drugs Darunavir co-administered with cobicistat is an inhibitor of CYP3A and CYP2D6. Cobicistat inhibits the following transporters: P-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 and OATP1B3. Therefore, co-administration of PREZCOBIX or PREZCOBIX PED with drugs that are primarily metabolized by CYP3A and/or CYP2D6 or are substrates of P-gp, BCRP, MATE1, OATP1B1 or OATP1B3 may result in increased plasma concentrations of such drugs, which could increase or prolong their therapeutic effect and can be associated with adverse events.

Co-administration of PREZCOBIX or PREZCOBIX PED with drugs that have active metabolite(s) formed by CYP3A may result in reduced plasma concentrations of these active metabolite(s), potentially leading to loss of their therapeutic effect (see Table 2 ).

7.2Potential for Other Drugs to Affect PREZCOBIX or PREZCOBIX PED Darunavir is metabolized by CYP3A. Cobicistat is metabolized by CYP3A, and to a minor extent, by CYP2D6. Co-administration of PREZCOBIX or PREZCOBIX PED and drugs that induce CYP3A activity are expected to increase the clearance of darunavir and cobicistat, resulting in lowered plasma concentrations of darunavir and cobicistat which may lead to loss of therapeutic effect and development of resistance.

Co-administration of PREZCOBIX or PREZCOBIX PED and other drugs that inhibit CYP3A may result in increased plasma concentrations of darunavir and cobicistat (see Table 2 ).

7.3Established and Other Potentially Significant Drug Interactions Table 2 provides dosing recommendations for expected clinically relevant interactions with PREZCOBIX or PREZCOBIX PED (this table is not all inclusive). These recommendations are based on either drug interaction trials or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or loss of therapeutic effect. The table includes examples of potentially significant interactions but is not all inclusive , and therefore the label of each drug that is co-administered with PREZCOBIX or PREZCOBIX PED should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regard to co-administration.

For the list of examples of contraindicated drugs, [see Contraindications (4) ] . Table 2: Established and Other Potentially Significant this table is not all inclusive Drug Interactions: Alterations in Dose or Regimen May Be Recommended Concomitant Drug Class: Drug Name Examples Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug Clinical Comment HIV-1 antiviral agents: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) didanosine ↔ darunavir ↔ cobicistat ↔ didanosine Didanosine should be administered one hour before or two hours after PREZCOBIX or PREZCOBIX PED (administered with food).

HIV-1 antiviral agents: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) efavirenz ↓ cobicistat ↓ darunavir Co-administration with efavirenz is not recommended because it may result in loss of therapeutic effect and development of resistance to darunavir. etravirine ↓ cobicistat darunavir: effect unknown Co-administration with etravirine is not recommended because it may result in loss of therapeutic effect and development of resistance to darunavir. nevirapine ↓ cobicistat darunavir: effect unknown Co-administration with nevirapine is not recommended because it may result in loss of therapeutic effect and development of resistance to darunavir.

HIV-1 antiviral agents: CCR5 co-receptor antagonists maraviroc ↑ maraviroc Maraviroc is a substrate of CYP… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: PREZCOBIX or PREZCOBIX PED is not recommended during pregnancy due to substantially lower exposures of darunavir and cobicistat during pregnancy. ( 8.1 , 12.3 ) Lactation: Breastfeeding is not recommended. ( 8.2 ) Pediatrics: Not recommended for pediatric patients younger than 3 years or weighing less than 15 kg. ( 8.4 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PREZCOBIX or PREZCOBIX PED during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) 1-800-258-4263. Risk Summary PREZCOBIX or PREZCOBIX PED is not recommended during pregnancy because of substantially lower exposures of darunavir and cobicistat during the second and third trimesters [see Dosage and Administration (2.7) ] .

A study evaluating the pharmacokinetics of antiretrovirals during pregnancy demonstrated substantially lower exposures of darunavir and cobicistat in the second and third trimesters compared to the post-partum period (see Data ) and [see Clinical Pharmacology (12.3) ]. Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects or miscarriage. However, available data from the APR show no statistically significant difference in the overall risk of major birth defects for darunavir and cobicistat compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data ) .

The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15–20%. The background risk of major birth defects and miscarriage for the indicated population is unknown.

In animal reproduction studies, no adverse developmental effects were observed when the components of PREZCOBIX were administered separately at darunavir exposures less than 1 (mice and rabbits) and 3-times (rats), and at cobicistat exposures 1.6 (rats) and 3.8 (rabbits) times human exposures at the recommended daily dose of these components in PREZCOBIX (see Data ) . No adverse developmental effects were seen when cobicistat was administered to rats through lactation at cobicistat exposures up to 1.2 times the human exposure at the recommended therapeutic dose.

Clinical Considerations Not Recommended During Pregnancy PREZCOBIX or PREZCOBIX PED is not recommended for use during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy (see Data ) and [see Clinical Pharmacology (12.3) ] . PREZCOBIX or PREZCOBIX PED should not be initiated in pregnant individuals. An alternative regimen is recommended for individuals who become pregnant during therapy with PREZCOBIX or PREZCOBIX PED.

Data Human Data PREZCOBIX in combination with a background regimen was evaluated in a clinical trial of 7 pregnant participants taking PREZCOBIX (800 mg/150 mg) prior to enrollment and who were willing to remain on PREZCOBIX throughout the study. The study period included the second and third trimesters, and through 12 weeks postpartum. Six pregnant participants completed the trial.

Exposure to darunavir and cobicistat as part of an antiretroviral regimen was substantially lower during the second and third trimesters of pregnancy compared with postpartum [see Clinical Pharmacology (12.3) ] . One out of 6 pregnant participants who completed the study experienced virologic failure with HIV-1 RNA >1,000 copies/mL from the third trimester visit through the postpartum period. Five pregnant participants had sustained virologic response (HIV-1 RNA <50 copies/mL) throughout the study period.

There are no clinical data on the virologic response when PREZCOBIX is initiated during pregnancy. Prospective reports from the APR of overall major birth defects in preg… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PREZCOBIX or PREZCOBIX PED during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) 1-800-258-4263. Risk Summary PREZCOBIX or PREZCOBIX PED is not recommended during pregnancy because of substantially lower exposures of darunavir and cobicistat during the second and third trimesters [see Dosage and Administration (2.7) ] .

A study evaluating the pharmacokinetics of antiretrovirals during pregnancy demonstrated substantially lower exposures of darunavir and cobicistat in the second and third trimesters compared to the post-partum period (see Data ) and [see Clinical Pharmacology (12.3) ]. Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects or miscarriage. However, available data from the APR show no statistically significant difference in the overall risk of major birth defects for darunavir and cobicistat compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data ) .

The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15–20%. The background risk of major birth defects and miscarriage for the indicated population is unknown.

In animal reproduction studies, no adverse developmental effects were observed when the components of PREZCOBIX were administered separately at darunavir exposures less than 1 (mice and rabbits) and 3-times (rats), and at cobicistat exposures 1.6 (rats) and 3.8 (rabbits) times human exposures at the recommended daily dose of these components in PREZCOBIX (see Data ) . No adverse developmental effects were seen when cobicistat was administered to rats through lactation at cobicistat exposures up to 1.2 times the human exposure at the recommended therapeutic dose.

Clinical Considerations Not Recommended During Pregnancy PREZCOBIX or PREZCOBIX PED is not recommended for use during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy (see Data ) and [see Clinical Pharmacology (12.3) ] . PREZCOBIX or PREZCOBIX PED should not be initiated in pregnant individuals. An alternative regimen is recommended for individuals who become pregnant during therapy with PREZCOBIX or PREZCOBIX PED.

Data Human Data PREZCOBIX in combination with a background regimen was evaluated in a clinical trial of 7 pregnant participants taking PREZCOBIX (800 mg/150 mg) prior to enrollment and who were willing to remain on PREZCOBIX throughout the study. The study period included the second and third trimesters, and through 12 weeks postpartum. Six pregnant participants completed the trial.

Exposure to darunavir and cobicistat as part of an antiretroviral regimen was substantially lower during the second and third trimesters of pregnancy compared with postpartum [see Clinical Pharmacology (12.3) ] . One out of 6 pregnant participants who completed the study experienced virologic failure with HIV-1 RNA >1,000 copies/mL from the third trimester visit through the postpartum period. Five pregnant participants had sustained virologic response (HIV-1 RNA <50 copies/mL) throughout the study period.

There are no clinical data on the virologic response when PREZCOBIX is initiated during pregnancy. Prospective reports from the APR of overall major birth defects in pregnancies exposed to the components of PREZCOBIX are compared with a U.S. background major birth defect rate. Methodological limitations of the APR include the use of MACDP as the external comparator group.

Limitations of using an external comparator include differences in methodology and populations, as well as confounding due to the underlying disease. There wer… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of PREZCOBIX and PREZCOBIX PED for the treatment of HIV-1 in pediatric patients 3 years of age and older weighing at least 15 kg was established through a trial with components of PREZCOBIX and PREZCOBIX PED. Use of PREZCOBIX or PREZCOBIX PED in this group is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic, safety, and virologic data from a study of components of PREZCOBIX or PREZCOBIX PED (Trial GS-US-216-0128) in pediatric participants with HIV-1 aged 3 to less than 18 years [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.2) ] .

The safety and effectiveness of PREZCOBIX or PREZCOBIX PED have not been established in pediatric patients weighing less than 15 kg. Darunavir, a component of PREZCOBIX and PREZCOBIX PED is not recommended in pediatric patients below 3 years of age because of toxicity and mortality observed in juvenile rats dosed with darunavir. Juvenile Animal Toxicity Data Darunavir: In a juvenile toxicity study where rats were directly dosed with darunavir (up to 1000 mg/kg), deaths occurred from post-natal day 5 at plasma exposure levels ranging from 0.1 to 1.0 of the human exposure levels.

In a 4-week rat toxicology study, when dosing was initiated on post-natal day 23 (the human equivalent of 2 to 3 years of age), no deaths were observed with a plasma exposure (in combination with ritonavir) 2 times the human plasma exposure levels.

🧓 Geriatric Use 65 words ▾

8.5Geriatric Use Clinical trials of PREZCOBIX did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, caution should be exercised in the administration and monitoring of PREZCOBIX in elderly patients, reflecting the greater frequency of decreased hepatic function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 75 words ▾

10 OVERDOSAGE Human experience of acute overdose with PREZCOBIX or PREZCOBIX PED is limited. No specific antidote is available for overdose with PREZCOBIX or PREZCOBIX PED. Treatment of overdose with PREZCOBIX or PREZCOBIX PED consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.

Since both darunavir and cobicistat are highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action PREZCOBIX and PREZCOBIX PED are fixed-dose combinations of an HIV-1 antiviral drug, darunavir and a CYP3A inhibitor, cobicistat [see Microbiology (12.4) ].

12.2Pharmacodynamics Cardiac Electrophysiology Separate thorough QT trials have been conducted for darunavir co-administered with ritonavir and for cobicistat. The effect of darunavir co-administered with cobicistat on the QT interval has not been evaluated. Darunavir : In a thorough QT/QTc study in 40 healthy participants, darunavir doses (co-administered with 100 mg ritonavir) of approximately 2 times the recommended darunavir dose did not affect the QT/QTc interval.

Cobicistat : The effect of a single dose of cobicistat 250 mg and 400 mg (approximately 1.7 and 2.7 times the recommended dose) on QTc interval was evaluated in a randomized, placebo- and active-controlled (moxifloxacin 400 mg) four-period crossover thorough QT trial in 48 healthy participants. In this trial, no significant QTc prolongation effect of cobicistat was detected. The dose of 400 mg cobicistat is expected to provide information on a high exposure clinical scenario.

Prolongation of the PR interval was noted in participants receiving cobicistat in the same trial. The maximum mean (95% upper confidence bound) difference in PR from placebo after baseline-correction was 9.5 (12.1) msec for 250 mg and 20.2 (22.8) msec for 400 mg of cobicistat . Effects on Serum Creatinine Cobicistat : The effect of cobicistat on serum creatinine was investigated in a trial in participants with normal renal function (eGFR ≥80 mL/min, N=12) and mild-to-moderate renal impairment (eGFR 50–79 mL/min, N=18).

A statistically significant decrease in the estimated glomerular filtration rate, calculated by Cockcroft-Gault method (eGFR CG ) from baseline, was observed after 7 days of treatment with cobicistat 150 mg among participants with normal renal function (-9.9 ± 13.1 mL/min) and mild-to-moderate renal impairment (-11.9 ± 7.0 mL/min). No statistically significant changes in eGFR CG were observed compared to baseline for participants with normal renal function or mild-to-moderate renal impairment 7 days after cobicistat was discontinued.

The actual glomerular filtration rate, as determined by the clearance of probe drug iohexol, was not altered from baseline following treatment of cobicistat among participants with normal renal function and mild-to-moderate renal impairment, indicating that cobicistat inhibits tubular secretion of creatinine, reflected as a reduction in eGFR CG , without affecting the actual glomerular filtration rate.

12.3Pharmacokinetics The pharmacokinetics of darunavir co-administered with cobicistat (150 mg) have been evaluated in healthy adults and in adults with HIV-1. Darunavir is primarily metabolized by CYP3A. Cobicistat inhibits CYP3A, thereby increasing the plasma concentrations of darunavir.

Under fed (535 total kcal, 171 kcal from fat, 268 kcal from carbohydrates, 96 kcal from protein) and fasted conditions in healthy participants, the 90% confidence intervals when comparing darunavir exposure between PREZCOBIX (800 mg/150 mg) and darunavir 800 mg co-administered with cobicistat 150 mg as single entities were within 80–125%. No clinically significant difference was observed between PREZCOBIX (675 mg/150 mg) and darunavir 675 mg co-administered with cobicistat 150 mg as single entities under fed conditions in healthy adults.

No clinically significant difference was observed between PREZCOBIX PED (600 mg/90 mg) and darunavir suspension (100 mg/mL) at a dose of 600 mg co-administered with cobicistat 90 mg as single entities under fed conditions in healthy adults. Darunavir exposure when comparing darunavir co-administered with cobicistat (as single entities) to darunavir co-administered with ritonavir was evaluated in a relative bioavailability trial [see cobicistat full prescribing information]. Table 3 displays the pharmacokinetic estimates of da… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 26 words ▾

12.1Mechanism of Action PREZCOBIX and PREZCOBIX PED are fixed-dose combinations of an HIV-1 antiviral drug, darunavir and a CYP3A inhibitor, cobicistat [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING PREZCOBIX Tablets PREZCOBIX ® (darunavir and cobicistat) tablets, 800/150 mg, are supplied as pink, oval-shaped, film-coated tablets debossed with "800" on one side and "TG" on the other side. Bottle of 30 tablets with child-resistant closure (NDC 59676-575-30). PREZCOBIX ® (darunavir and cobicistat) tablets, 675/150 mg, are supplied as green to dark green, oval-shaped, scored film-coated tablet debossed with "675" on one side and "TG" on the other side.

Bottle of 30 tablets with child-resistant closure (NDC 59676-578-30). Storage of PREZCOBIX tablets: Store at 20 °C to 25 °C (between 68 °F to 77 °F); with excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature]. PREZCOBIX PED Tablets for Oral Suspension PREZCOBIX ® PED (darunavir and cobicistat) tablets for oral suspension, 600/90 mg, are supplied as reddish purple, oval-shaped, film-coated tablets debossed with "690" on one side and "TG" on the other side.

Bottle of 30 tablets with child-resistant closure (NDC 59676-577-30). Storage of PREZCOBIX PED tablets for oral suspension: Store in the original container in order to protect from light. Keep the container tightly closed.

Store at 20 °C to 25 °C (between 68 °F to 77 °F); with excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature]. Keep PREZCOBIX, PREZCOBIX PED, and all medicines out of reach of children.

📦 Storage and Handling 151 words ▾

Storage of PREZCOBIX tablets: Store at 20 °C to 25 °C (between 68 °F to 77 °F); with excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature]. PREZCOBIX PED Tablets for Oral Suspension PREZCOBIX ® PED (darunavir and cobicistat) tablets for oral suspension, 600/90 mg, are supplied as reddish purple, oval-shaped, film-coated tablets debossed with "690" on one side and "TG" on the other side. Bottle of 30 tablets with child-resistant closure (NDC 59676-577-30).

Storage of PREZCOBIX PED tablets for oral suspension: Store in the original container in order to protect from light. Keep the container tightly closed. Store at 20 °C to 25 °C (between 68 °F to 77 °F); with excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature].

Keep PREZCOBIX, PREZCOBIX PED, and all medicines out of reach of children.

📋 Description ~2 min read ▾

11 DESCRIPTION PREZCOBIX and PREZCOBIX PED are fixed-dose combination products containing darunavir and cobicistat. Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family.

Darunavir : Darunavir, in the form of darunavir ethanolate, has the following chemical name: [(1 S ,2 R )-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3 R ,3a S ,6a R )-hexahydrofuro[2,3- b ]furan-3-yl ester monoethanolate. Its molecular formula is C 27 H 37 N 3 O 7 S ∙ C 2 H 5 OH and its molecular weight is 593.73. Darunavir ethanolate has the following structural formula: Cobicistat : Cobicistat is adsorbed onto silicon dioxide.

The chemical name for cobicistat is 1,3-thiazol-5-ylmethyl[(2 R ,5 R )-5-{[(2 S )2-[(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)amino]-4-(morpholin-4yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate. It has a molecular formula of C 40 H 53 N 7 O 5 S 2 and a molecular weight of 776.0. It has the following structural formula: PREZCOBIX ® 800 mg darunavir/150 mg cobicistat tablets are for oral administration.

Each tablet contains darunavir ethanolate equivalent to 800 mg of darunavir and 150 mg of cobicistat. The tablets include the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, and silicified microcrystalline cellulose. The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide.

PREZCOBIX ® 675 mg darunavir/150 mg cobicistat tablets are for oral administration. Each tablet contains darunavir ethanolate equivalent to 675 mg of darunavir and 150 mg of cobicistat. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.

The tablets are film-coated with a coating material containing iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. PREZCOBIX ® PED 600 mg darunavir/90 mg cobicistat tablets for oral suspension are for oral administration. Each tablet for oral suspension contains darunavir ethanolate equivalent to 600 mg of darunavir and 90 mg of cobicistat.

The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, silicified microcrystalline cellulose, strawberry flavor, and sucralose. The tablets are film-coated with a coating material containing glycerol monocaprylocaprate type 1, iron oxide red, iron oxide black, macrogol polyvinyl alcohol graft copolymer, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. Chemical Structure Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Instructions for Use Advise patients to take PREZCOBIX or PREZCOBIX PED with food every day on a regular dosing schedule, as missed doses can result in development of resistance. Inform patients not to alter the dose of PREZCOBIX or PREZCOBIX PED or discontinue therapy with PREZCOBIX or PREZCOBIX PED without consulting their physician [see Dosage and Administration (2.2) ].

Inform patients and caregivers that PREZCOBIX PED tablets for oral suspension must be dispersed in drinking water and not be crushed, chewed, or swallowed [see Dosage and Administration (2.1 , 2.3) ]. Hepatotoxicity Inform patients that drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) and liver injury, including some fatalities, could potentially occur with PREZCOBIX or PREZCOBIX PED. Advise patients to contact their healthcare provider immediately if signs and symptoms of liver problems develop [see Warnings and Precautions (5.1) ] .

Severe Skin Reactions Inform patients that skin reactions ranging from mild to severe, including Stevens-Johnson Syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, could potentially occur with PREZCOBIX or PREZCOBIX PED. Advise patients to contact their healthcare provider immediately if signs or symptoms of severe skin reactions develop, including but not limited to severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, and/or conjunctivitis [see Warnings and Precautions (5.2) ] .

Renal Impairment Inform patients that renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported when cobicistat is used in combination with a tenofovir DF-containing regimen [see Warnings and Precautions (5.4) ] . Pregnancy Advise patients that PREZCOBIX or PREZCOBIX PED is not recommended during pregnancy and to alert their healthcare provider if they get pregnant while taking PREZCOBIX or PREZCOBIX PED [see Use in Specific Populations (8.1) ] . Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant individuals exposed to PREZCOBIX or PREZCOBIX PED [see Use in Specific Populations (8.1) ].

Lactation Inform patients that the potential risks of breastfeeding include: (1) HIV-1 transmission (in infants without HIV-1), (2) developing viral resistance (in infants with HIV-1), and (3) serious adverse reactions in a breastfed infant similar to those seen in adults [see Use in Specific Populations (8.2) ] . Drug Interactions PREZCOBIX or PREZCOBIX PED may interact with many drugs; therefore, inform patients of the potential serious drug interactions with PREZCOBIX or PREZCOBIX PED, and that some drugs are contraindicated with PREZCOBIX or PREZCOBIX PED and other drugs may require dosage adjustment.

Advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including St. John's wort. Immune Reconstitution Syndrome Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.10) ] .

Fat Redistribution Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including PREZCOBIX or PREZCOBIX PED and that the cause and long-term health effects of these conditions are not known at this time [see Warnings and Precautions (5.9) ] .

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of darunavir co-administered with cobicistat (150 mg) have been evaluated in healthy adults and in adults with HIV-1. Darunavir is primarily metabolized by CYP3A. Cobicistat inhibits CYP3A, thereby increasing the plasma concentrations of darunavir.

Under fed (535 total kcal, 171 kcal from fat, 268 kcal from carbohydrates, 96 kcal from protein) and fasted conditions in healthy participants, the 90% confidence intervals when comparing darunavir exposure between PREZCOBIX (800 mg/150 mg) and darunavir 800 mg co-administered with cobicistat 150 mg as single entities were within 80–125%. No clinically significant difference was observed between PREZCOBIX (675 mg/150 mg) and darunavir 675 mg co-administered with cobicistat 150 mg as single entities under fed conditions in healthy adults.

No clinically significant difference was observed between PREZCOBIX PED (600 mg/90 mg) and darunavir suspension (100 mg/mL) at a dose of 600 mg co-administered with cobicistat 90 mg as single entities under fed conditions in healthy adults. Darunavir exposure when comparing darunavir co-administered with cobicistat (as single entities) to darunavir co-administered with ritonavir was evaluated in a relative bioavailability trial [see cobicistat full prescribing information]. Table 3 displays the pharmacokinetic estimates of darunavir after oral administration of darunavir 800 mg co-administered with ritonavir 100 mg once daily (based on sparse sampling in 335 participants in Trial TMC114-C211 and 280 participants in Trial TMC114-C229) and darunavir 800 mg co-administered with cobicistat 150 mg once daily administered as single entities (based on sparse sampling in 298 participants in Trial GS-US-216-0130) to HIV-1 participants.

Table 3: Pharmacokinetic Estimates of Darunavir as Darunavir 800 mg Co-administered with Ritonavir 100 mg Once Daily (Trial TMC114-C211, 48 Week Analysis and Trial TMC114-C229, 48 Week Analysis) and Darunavir 800 mg Co-administered with Cobicistat 150 mg Once Daily (Trial GS-US-216-0130, 24 Week Analysis) Trial TMC114-C211 (treatment-naïve) Darunavir 800 mg co-administered with ritonavir 100 mg once daily Trial TMC114-C229 (treatment-experienced) Darunavir 800 mg co-administered with ritonavir 100 mg once daily Trial GS-US-216-0130 (treatment-naïve and experienced) Darunavir 800 mg co-administered with cobicistat 150 mg once daily Parameter N=335 N=280 N=298 AUC 0–24h =area under the concentration-time curve over a 24-hour dosing interval at steady state; C 0h =plasma concentration at the end of a 24-hour dosing interval at steady state; N=number of participants; SD=standard deviation AUC 0–24h (ng∙h/mL) Mean ± SD 93026 ± 27050 93334 ± 28626 100152 ± 32042 Median (Range) 87854 (45000–219240) 87788 (45456–236920) 96900 (34500–224000) C 0h (ng/mL) Mean ± SD 2282 ± 1168 2160 ± 1201 2043 ± 1257 Median (Range) 2041 (368–7242) 1896 (184–7881) 1875 (70–6890) Absorption and Bioavailability In healthy participants, under fed conditions, when single doses of the darunavir and cobicistat fixed-dose combination tablet were administered, the maximum plasma concentration was achieved within approximately 4 to 4.5 hours for darunavir and approximately 4 to 5 hours for cobicistat.

Effects of Food on Oral Absorption When compared to fasted conditions, administration of PREZCOBIX (800 mg/150 mg) to healthy adult participants with a high-fat meal (965 total kcal: 129 kcal from protein, 236 kcal from carbohydrates and 600 kcal from fat) resulted in a 70% increase in AUC (0–inf) and a 127% increase in C max for darunavir. Cobicistat exposures were not affected by food. PREZCOBIX or PREZCOBIX PED should be taken with food.

Distribution Darunavir : Darunavir is approximately 95% bound to plasma proteins. Darunavir binds primarily to plasma alpha 1-acid glycoprotein (AAG). Cobicistat : Cobicistat is 97–98% bound to human plasma proteins and the mean blood–to-plasma ratio was approximately 0.5.

Metabolism Dar… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Cardiac Electrophysiology Separate thorough QT trials have been conducted for darunavir co-administered with ritonavir and for cobicistat. The effect of darunavir co-administered with cobicistat on the QT interval has not been evaluated. Darunavir : In a thorough QT/QTc study in 40 healthy participants, darunavir doses (co-administered with 100 mg ritonavir) of approximately 2 times the recommended darunavir dose did not affect the QT/QTc interval.

Cobicistat : The effect of a single dose of cobicistat 250 mg and 400 mg (approximately 1.7 and 2.7 times the recommended dose) on QTc interval was evaluated in a randomized, placebo- and active-controlled (moxifloxacin 400 mg) four-period crossover thorough QT trial in 48 healthy participants. In this trial, no significant QTc prolongation effect of cobicistat was detected. The dose of 400 mg cobicistat is expected to provide information on a high exposure clinical scenario.

Prolongation of the PR interval was noted in participants receiving cobicistat in the same trial. The maximum mean (95% upper confidence bound) difference in PR from placebo after baseline-correction was 9.5 (12.1) msec for 250 mg and 20.2 (22.8) msec for 400 mg of cobicistat . Effects on Serum Creatinine Cobicistat : The effect of cobicistat on serum creatinine was investigated in a trial in participants with normal renal function (eGFR ≥80 mL/min, N=12) and mild-to-moderate renal impairment (eGFR 50–79 mL/min, N=18).

A statistically significant decrease in the estimated glomerular filtration rate, calculated by Cockcroft-Gault method (eGFR CG ) from baseline, was observed after 7 days of treatment with cobicistat 150 mg among participants with normal renal function (-9.9 ± 13.1 mL/min) and mild-to-moderate renal impairment (-11.9 ± 7.0 mL/min). No statistically significant changes in eGFR CG were observed compared to baseline for participants with normal renal function or mild-to-moderate renal impairment 7 days after cobicistat was discontinued.

The actual glomerular filtration rate, as determined by the clearance of probe drug iohexol, was not altered from baseline following treatment of cobicistat among participants with normal renal function and mild-to-moderate renal impairment, indicating that cobicistat inhibits tubular secretion of creatinine, reflected as a reduction in eGFR CG , without affecting the actual glomerular filtration rate.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Clinical Trial Results in Adults with HIV-1 The efficacy of PREZCOBIX in adults with HIV-1 is based on efficacy demonstrated in clinical trials of darunavir co-administered with ritonavir [see darunavir full prescribing information].

14.2Clinical Trial Results in Pediatrics with HIV-1 Trial GS-US-216-0128 was a Phase 2/3 multicenter, open-label trial to evaluate the pharmacokinetics, safety, and efficacy of darunavir co-administered with cobicistat in pediatric participants aged 12 years and older (Cohort 1), aged 6 to less than 12 years old (Cohort 2), and aged 3 years and older (Cohort 3), with HIV-1 who were virologically suppressed and had a baseline estimated creatinine clearance ≥90 mL/min/1.73 m 2 . Participants were on a stable antiretroviral regimen including at least 2 NRTIs (for at least 3 months).

Cohort 1: The median age of participants was 14 years (range 12–16 years), median weight was 60 kg (range 45–78 kg), and 43% were male. At baseline, all had plasma HIV-1 RNA <50 copies/mL. At Week 48, 86% (6/7) of participants remained suppressed (HIV-1 RNA <50 copies/mL), and 1 had missing data.

From a median baseline CD4+ cell count and CD4+% of 1,117 cells/mm 3 (range 658 to 2,416 cells/mm 3 ) and 45% (range 28% to 56%), respectively, the median change from baseline in CD4+ cell count and CD4+% at Week 48 was -342 cells/mm 3 (range -1,389 to 219 cells/mm 3 ) and -6% (range -12% to 5%), respectively. All 6 participants with available data had CD4+ cell counts above 800 cells/mm 3 at Week 48. Cohort 2: The median age of participants was 10 years (range 7–11 years), median weight was 31.7 kg (range 29.1–45.4 kg), and 75% were female.

At baseline, all had plasma HIV-1 RNA <50 copies/mL. At Week 48, all participants remained suppressed (HIV-1 RNA <50 copies/mL). From a median baseline CD4+ cell count and CD4+% of 998 cells/mm 3 (range 439 to 1113 cells/mm 3 ) and 40% (range 29.1% to 48.5%), respectively, the median change from baseline in CD4+ cell count and CD4+% at Week 48 was -20 cells/mm 3 (range -318 to 245) and 0.75% (-11.40 to 3.20), respectively.

Cohort 3: The median age of participants was 4 years (range: 3 – 7 years), median weight was 17 kg (range 14.7 to 22.0 kg), 55% were female. At baseline, all had plasma HIV-1 RNA <50 copies/mL. At week 48, 91% (10/11) of participants remained suppressed (HIV-1 RNA <50 copies/mL), and 1 had missing data.

From a median baseline CD4+ cell count and CD4+% of 1,237 cells/mm 3 (range 705 to 1,636 cells/mm 3 ) and 35.9% (range 25.3% to 49.1%), respectively, the median change from baseline in CD4+ cell count and CD4+% at Week 48 was 34 cells/mm 3 (range -755 to 180) and 1.5% (range -3.00 to 5.50), respectively.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis Darunavir : Darunavir was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks. Daily doses of 150, 450 and 1000 mg/kg were administered to mice and doses of 50, 150 and 500 mg/kg were administered to rats. A dose-related increase in the incidence of hepatocellular adenomas and carcinomas was observed in males and females of both species and an increase in thyroid follicular cell adenomas was observed in male rats.

The observed hepatocellular findings in rodents are considered to be of limited relevance to humans. Repeated administration of darunavir to rats caused hepatic microsomal enzyme induction and increased thyroid hormone elimination, which predispose rats but not humans, to thyroid neoplasms. At the highest tested doses, the systemic exposures to darunavir (based on AUC) were between 0.4- and 0.7-fold (mice) and 0.7- and 1-fold (rats) of exposures observed in humans at the recommended therapeutic doses (darunavir 600 mg co-administered with ritonavir 100 mg twice daily or darunavir 800 mg co-administered with ritonavir 100 mg once daily).

Darunavir was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation (Ames), chromosomal aberration in human lymphocytes, and in vivo micronucleus test in mice. Cobicistat : In a long-term carcinogenicity study in mice, no drug-related increases in tumor incidence were observed at doses up to 50 and 100 mg/kg/day in males and females, respectively. Cobicistat exposures at these doses were approximately 7 (male) and 16 (females) times, respectively, the human systemic exposure at the therapeutic daily dose.

In a long-term carcinogenicity study of cobicistat in rats, an increased incidence of follicular cell adenomas and/or carcinomas in the thyroid gland was observed at doses of 25 and 50 mg/kg/day in males, and at 30 mg/kg/day in females. The follicular cell findings are considered to be rat-specific, secondary to hepatic microsomal enzyme induction and thyroid hormone imbalance, and are not relevant for humans. At the highest doses tested in the rat carcinogenicity study, systemic exposures were approximately 2 times the human systemic exposure at the therapeutic daily dose.

Cobicistat was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or rat micronucleus assays. Impairment of Fertility Darunavir : No effects on fertility or early embryonic development were observed with darunavir in rats. Cobicistat : Cobicistat did not affect fertility in male or female rats at daily exposures (AUC) approximately 4-fold higher than human exposures at the recommended 150 mg daily dose.

Fertility was normal in the offspring of rats exposed daily from before birth ( in utero ) through sexual maturity at daily exposures (AUC) of approximately 1.2-fold higher than human exposures at the recommended 150 mg daily dose.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis Darunavir : Darunavir was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks. Daily doses of 150, 450 and 1000 mg/kg were administered to mice and doses of 50, 150 and 500 mg/kg were administered to rats. A dose-related increase in the incidence of hepatocellular adenomas and carcinomas was observed in males and females of both species and an increase in thyroid follicular cell adenomas was observed in male rats.

The observed hepatocellular findings in rodents are considered to be of limited relevance to humans. Repeated administration of darunavir to rats caused hepatic microsomal enzyme induction and increased thyroid hormone elimination, which predispose rats but not humans, to thyroid neoplasms. At the highest tested doses, the systemic exposures to darunavir (based on AUC) were between 0.4- and 0.7-fold (mice) and 0.7- and 1-fold (rats) of exposures observed in humans at the recommended therapeutic doses (darunavir 600 mg co-administered with ritonavir 100 mg twice daily or darunavir 800 mg co-administered with ritonavir 100 mg once daily).

Darunavir was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation (Ames), chromosomal aberration in human lymphocytes, and in vivo micronucleus test in mice. Cobicistat : In a long-term carcinogenicity study in mice, no drug-related increases in tumor incidence were observed at doses up to 50 and 100 mg/kg/day in males and females, respectively. Cobicistat exposures at these doses were approximately 7 (male) and 16 (females) times, respectively, the human systemic exposure at the therapeutic daily dose.

In a long-term carcinogenicity study of cobicistat in rats, an increased incidence of follicular cell adenomas and/or carcinomas in the thyroid gland was observed at doses of 25 and 50 mg/kg/day in males, and at 30 mg/kg/day in females. The follicular cell findings are considered to be rat-specific, secondary to hepatic microsomal enzyme induction and thyroid hormone imbalance, and are not relevant for humans. At the highest doses tested in the rat carcinogenicity study, systemic exposures were approximately 2 times the human systemic exposure at the therapeutic daily dose.

Cobicistat was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or rat micronucleus assays. Impairment of Fertility Darunavir : No effects on fertility or early embryonic development were observed with darunavir in rats. Cobicistat : Cobicistat did not affect fertility in male or female rats at daily exposures (AUC) approximately 4-fold higher than human exposures at the recommended 150 mg daily dose.

Fertility was normal in the offspring of rats exposed daily from before birth ( in utero ) through sexual maturity at daily exposures (AUC) of approximately 1.2-fold higher than human exposures at the recommended 150 mg daily dose.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 02/2026 PATIENT INFORMATION PREZCOBIX ® (prez-koe-bix) (darunavir and cobicistat) tablets PREZCOBIX ® PED (prez-koe-bix ped) (darunavir and cobicistat) tablets for oral suspension What is the most important information I should know about PREZCOBIX and PREZCOBIX PED?

PREZCOBIX and PREZCOBIX PED may cause serious side effects, including: Liver problems. People taking PREZCOBIX or PREZCOBIX PED may develop liver problems which may be life-threatening and can lead to death. Your healthcare provider should do blood tests before and during your treatment with PREZCOBIX or PREZCOBIX PED.

If you have chronic hepatitis B or C or other liver problems, your healthcare provider may check your blood tests more often because you have an increased risk of developing liver problems. Tell your healthcare provider right away if you develop any new or worsening signs or symptoms of liver problems, including: tiredness dark (tea colored) urine yellowing of your skin or whites of your eyes pale colored stools (bowel movements) nausea vomiting pain or tenderness on your right side below your ribs loss of appetite Severe skin reactions or rash.

Skin rash is common during treatment with PREZCOBIX or PREZCOBIX PED but can become severe and require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking PREZCOBIX or PREZCOBIX PED and call your healthcare provider right away if you develop a severe rash or a rash with any of the following symptoms: fever tiredness muscle or joint pain blisters or skin lesions mouth sores or ulcers red or inflamed eyes, like "pink eye" (conjunctivitis) Kidney problems.

PREZCOBIX and PREZCOBIX PED when taken with certain other medicines can cause new or worsening kidney problems, including kidney failure. Your healthcare provider should check your kidneys before you start and during treatment with PREZCOBIX or PREZCOBIX PED. See " What are the possible side effects of PREZCOBIX or PREZCOBIX PED? " for more information about side effects.

What are PREZCOBIX and PREZCOBIX PED? PREZCOBIX and PREZCOBIX PED are prescription medicines that are used with other human immunodeficiency virus (HIV-1) medicines to treat HIV-1 in adults and in children 3 years of age and older who weigh at least 33 pounds (15 kg). HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

PREZCOBIX and PREZCOBIX PED contain the prescription medicines darunavir and cobicistat. It is not known if PREZCOBIX or PREZCOBIX PED are safe and effective in children weighing less than 33 pounds (15 kg). Do not take PREZCOBIX or PREZCOBIX PED with any medicine that contains: alfuzosin carbamazepine colchicine, if you have liver or kidney problems dronedarone elbasvir and grazoprevir ergot-containing medicines: dihydroergotamine ergotamine tartrate methylergonovine ivabradine lomitapide lovastatin lurasidone midazolam, when taken by mouth naloxegol phenobarbital phenytoin pimozide ranolazine rifampin sildenafil, when used for the treatment of pulmonary arterial hypertension (PAH) simvastatin St.

John's wort ( Hypericum perforatum ) triazolam Serious problems can happen if you take any of these medicines with PREZCOBIX or PREZCOBIX PED. This is not a complete list of medicines. Therefore, tell your healthcare provider about all medicines you take.

Before taking PREZCOBIX or PREZCOBIX PED, tell your healthcare provider about all your medical conditions, including if you: have liver problems, including hepatitis B or hepatitis C, or liver disease (cirrhosis) have kidney problems are allergic to sulfa (sulfonamide) have diabetes have hemophilia are pregnant or plan to become pregnant. It is not known if PREZCOBIX or PREZCOBIX PED will harm your unborn baby. PREZCOBIX or PREZCOBIX PED should not be used during pregnancy because the PREZCOBIX or PREZCOBIX PED levels in your blood may be lower during pregnancy and may… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: 02/2026 INSTRUCTIONS FOR USE PREZCOBIX ® PED (prez-koe-bix ped) (darunavir and cobicistat) tablets for oral suspension This Instructions for Use contains information on how to prepare and give PREZCOBIX PED.

Read this Instructions for Use before your child starts taking PREZCOBIX PED for the first time and each time you get a refill. There may be new information. Important information you need to know before giving PREZCOBIX PED: Give PREZCOBIX PED exactly as your healthcare provider tells you.

Each time you receive your child's prescription, check the bottle to make sure that you received PREZCOBIX PED tablets for oral suspension. PREZCOBIX PED tablets for oral suspension are not the same as PREZCOBIX tablets. Contact your pharmacist or healthcare provider if you did not receive the correct dosage form.

Do not crush, chew or swallow PREZCOBIX PED tablets for oral suspension. Talk to your healthcare provider or pharmacist if you have any questions on how to prepare or give the prescribed dose of PREZCOBIX PED. Supplies needed to prepare and give PREZCOBIX PED: bottle of PREZCOBIX PED tablets for oral suspension (not included with PREZCOBIX PED) a clean empty cup non-carbonated room temperature drinking water tablespoon teaspoon orange juice, applesauce, or yogurt (optional) Step 1: Remove the child-resistant cap from the PREZCOBIX PED bottle Open the bottle by pushing down on the child-resistant cap while turning it left (counter-clockwise).

Remove the unscrewed cap. Remove 1 tablet. Do not crush the tablet.

Step 2: Place the tablet in a cup Place the tablet in a clean empty cup. Step 3: Replace the child-resistant cap on the PREZCOBIX PED bottle Close the bottle by replacing the child-resistant cap and turning it right (clockwise). Step 4: Add 30 mL (2 tablespoons) of non-carbonated room temperature drinking water.

Add 30 mL (2 tablespoons) of non-carbonated room temperature drinking water to the cup. Do not crush the tablet. Step 5: Stir well with a spoon Stir well with a spoon until the tablet completely breaks apart (disperses).

The prepared medicine will appear reddish purple. If you spill any medicine, clean up the spill. Throw away the rest of the prepared medicine and make a new dose.

You must give the prepared medicine right away. If you do not give the prepared medicine right away, throw away the mixture and prepare a new dose of medicine. Step 6: Give PREZCOBIX PED Give all the prepared medicine right away or you may add 10 mL (2 teaspoons) of non-carbonated room temperature drinking water or orange juice, or 1 teaspoon of applesauce or yogurt to the prepared medicine to make it easier to take.

Mix and give all of the prepared medicine right away. Add another 5 mL (1 teaspoon) of non-carbonated drinking water to the cup, swirl and give to drink completely. Repeat this step as needed to make sure the entire dose is taken.

Step 7: Clean the dosing items Wash all the items used to prepare the medicine thoroughly with water. Make sure they are clean and dry before preparing the next dose. Storing PREZCOBIX PED Store PREZCOBIX PED at room temperature between 68 °F to 77 °F (20 °C to 25 °C).

PREZCOBIX PED comes in a bottle with a child-resistant cap. Store PREZCOBIX PED tablets for oral suspension in the original container to protect from light. Keep the container tightly closed.

Keep PREZCOBIX PED and all medicines out of the reach of children. Manufactured for: Janssen Products, LP, Horsham, PA 19044, USA For patent information: www.janssenpatents.com © Johnson & Johnson and its affiliates 2026 For more information call 1-800-526-7736. Image Image Image Image Image

📄 Recent Major Changes 18 words ▾

Indications and Usage ( 1 ) 02/2026 Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 02/2026

📄 Package Label / Principal Display Panel 160 words ▾

PRINCIPAL DISPLAY PANEL - 800 mg/150 mg Tablet Bottle Label NDC 59676-575-30 PREZCOBIX ® (darunavir and cobicistat) Tablets 800 mg/150 mg ALERT: Find out about medicines that should NOT be taken with PREZCOBIX ® from your healthcare provider. Rx only 30 Tablets Johnson &Johnson PREZCOBIX 800 mg PDP

PRINCIPAL DISPLAY PANEL - 675 mg/150 mg Tablet Bottle Carton NDC 59676-578-30 PREZCOBIX ® (darunavir and cobicistat) Tablets 675 mg/150 mg ALERT: Find out about medicines that should NOT be taken with PREZCOBIX ® from your healthcare provider. Rx only 30 Tablets Johnson & Johnson PRINCIPAL DISPLAY PANEL - 675 mg/150 mg Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 600 mg/90 mg Tablet Bottle Carton NDC 59676-577-30 PREZCOBIX ® PED (darunavir and cobicistat) Tablets for oral suspension. 600 mg/90 mg DISPENSE IN DRINKING WATER Do not crush, chew, or swallow whole, see Instructions for Use Rx only 30 Tablets Johnson & Johnson PRINCIPAL DISPLAY PANEL - 600 mg/90 mg Tablet Bottle Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
30.6K
Units reimbursed last 4 qtrs
1M
Gross reimbursed last 4 qtrs
$79.9M
Avg / prescription
$2,613.34
Avg / unit
$79.6970
Latest quarter Q1 2026
6.9KRx
Medicaid pays / ea
$79.6970
gross reimbursed
vs
NADAC / ea
$79.9938
acquisition cost
=
Spread
−$0.2968
+0% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
58% FFS 42% MCO
Fee-for-service · 17,814 Rx Managed care · 12,759 Rx
State Medicaid map
Alaska: 322 units · 43.9 per 100k residents AK Maine: 3,900 units · 280 per 100k residents ME Washington: 6,056 units · 77.5 per 100k residents WA Idaho: no data reported ID Montana: 1,830 units · 162 per 100k residents MT North Dakota: no data reported ND Minnesota: 4,033 units · 70.3 per 100k residents MN Wisconsin: 4,950 units · 83.8 per 100k residents WI Michigan: 23,954 units · 239 per 100k residents MI New York: 290,146 units · 1,483 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,530 units · 109 per 100k residents NH Oregon: 10,032 units · 237 per 100k residents OR Nevada: 10,257 units · 321 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 4,048 units · 126 per 100k residents IA Illinois: 28,438 units · 227 per 100k residents IL Indiana: 9,750 units · 142 per 100k residents IN Ohio: 19,331 units · 164 per 100k residents OH Pennsylvania: 46,359 units · 358 per 100k residents PA New Jersey: 16,924 units · 182 per 100k residents NJ Massachusetts: 18,248 units · 261 per 100k residents MA California: 120,882 units · 310 per 100k residents CA Utah: 2,073 units · 60.7 per 100k residents UT Colorado: 3,390 units · 57.7 per 100k residents CO Nebraska: 420 units · 21.2 per 100k residents NE Missouri: 15,900 units · 257 per 100k residents MO Kentucky: 3,431 units · 75.8 per 100k residents KY West Virginia: 1,080 units · 61.0 per 100k residents WV Virginia: 15,153 units · 174 per 100k residents VA Maryland: 31,093 units · 503 per 100k residents MD Connecticut: 21,789 units · 602 per 100k residents CT Rhode Island: 4,890 units · 447 per 100k residents RI Arizona: 14,122 units · 190 per 100k residents AZ New Mexico: 1,350 units · 63.9 per 100k residents NM Kansas: 810 units · 27.6 per 100k residents KS Arkansas: 2,340 units · 76.3 per 100k residents AR Tennessee: 13,619 units · 191 per 100k residents TN North Carolina: 41,402 units · 382 per 100k residents NC South Carolina: 3,870 units · 72.0 per 100k residents SC Delaware: 4,542 units · 441 per 100k residents DE Oklahoma: 9,390 units · 232 per 100k residents OK Louisiana: 28,505 units · 623 per 100k residents LA Mississippi: 2,970 units · 101 per 100k residents MS Alabama: 7,837 units · 153 per 100k residents AL Georgia: 27,780 units · 252 per 100k residents GA D.C.: 27,870 units · 4,105 per 100k residents DC Hawaii: 390 units · 27.2 per 100k residents HI Texas: 34,693 units · 114 per 100k residents TX Florida: 36,669 units · 162 per 100k residents FL
Units reimbursed · per 100k residents
21.24,105
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 D.C. 4,105 /100k
2 New York 1,483 /100k
3 Louisiana 623 /100k
4 Connecticut 602 /100k
5 Maryland 503 /100k
6 Rhode Island 447 /100k
7 Delaware 441 /100k
8 North Carolina 382 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Prezcobix — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Prezcobix. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$55.99M
Claims incl. refills
22.5K
Beneficiaries
8.7K
Spend / beneficiary
$6,419.09
Spend / claim
$2,486.95
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for DARUNAVIR ETHANOLATE and COBICISTAT — the ingredient across all brands.

Top reported reactions

Pain440
Emotional Distress426
Anxiety404
Anhedonia377
Chronic Kidney Disease256
Osteoporosis181
Bone Density Decreased170

Reporter sex

1,754 reports
Male · 75%
Female · 25%

Serious outcomes

Death135
Life-threatening24
Disabling13
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 289 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 59676-0572-01 · Janssen 59676-0577-30 · Janssen →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.