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PREZCOBIX PED DARUNAVIR ETHANOLATE and COBICISTAT 600 mg; 90 mg Tablet, For Suspension, 30-count — NDC 59676-0577-30 package photo

PREZCOBIX PED DARUNAVIR ETHANOLATE and COBICISTAT 600 mg; 90 mg Tablet, For Suspension, 30-count

by Janssen Products, LP · 30 TABLET, FOR SUSPENSION in 1 BOTTLE (59676-577-30)
NDC 59676-0577-30
🏷️ FDA NDC (as labeled) 59676-577-30 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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

🆔 Identity & classification

FDA NDC (as labeled) 59676-577-30
Product NDC 59676-577
11-digit billing NDC 59676057730
RxCUI 1600704, 1600710, 2710424, 2710426, 2738995, 2738999
UNII LW2E03M5PG, 33O78XF0BW
UPC 0359676575306
Application # NDA220092
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 2026-02-27
Route ORAL
Dosage form TABLET, FOR SUSPENSION
Substance DARUNAVIR ETHANOLATE; COBICISTAT
Why two NDCs? The FDA registers this code as 59676-577-30 — 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 → 59676-0577-30. 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.

🏭 Manufacturer & labeler

LabelerJanssen Products, LP
Application holderJANSSEN PRODUCTS LP
FDA applicationNDA220092 (NDA)
Labeler code59676
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio17 products on file
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.

🩺 Clinical

📗 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.

🧪 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.

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

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

13 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.

💲 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Prezcobix Ped 600 mg/1; 90 mgthis 59676-0577-30 Janssen 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59676-0577-30 You're viewing this 30 TABLET, FOR SUSPENSION in 1 BOTTLE (59676-577-30) 2026-02-27 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 59676-577-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 59676-0577-30, written without dashes as 59676057730. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 59676-0577-30, the first segment (59676) is the labeler code FDA assigned to Janssen Products, LP; the middle segment (0577) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Janssen Products, LP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Janssen Products, LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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
🎯 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 (…

💊 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 ~2 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…

🤒 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…

👥 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…

🤰 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…

🧒 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…

🧬 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) ] .

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