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IDVYNSO Doravirine, Islatravir 100 mg; .25 mg Tablet, Film Coated, 14-count — NDC 00006-5092-59 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

IDVYNSO Doravirine, Islatravir 100 mg; .25 mg Tablet, Film Coated, 14-count — NDC 0006-5092-59 (Billing 00006-5092-59)

by Merck Sharp & Dohme LLC · 14 TABLET, FILM COATED in 1 BOTTLE

This is a package of 14 tablets of IDVYNSO Doravirine, Islatravir 100 mg; .25 mg Tablet, Film Coated from Merck Sharp & Dohme LLC, marketed since Apr 2026 and currently FDA-listed.

NDC 00006-5092-59
🏷️ FDA NDC (as labeled) 0006-5092-59 billing pads the labeler segment with a zero
This package
Contains14-count Pack sizes2 compare ↓
Product page 00006-5092-01 Also comes in: 30 tablets 0006-5092-01
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 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 0006-5092-59 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0006 labeler · 5092 product · 59 package
Package marketed since
Apr 23, 2026
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Barcode (UPC)
0300065092010
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0006-5092-59
Product NDC 0006-5092
11-digit billing NDC 00006509259
RxCUI 2741694, 2741700
UNII 913P6LK81M, QPQ082R25D
UPC 0300065092010
Application # NDA216964
SPL Set ID 11aaeb53-9848-433c-be7f-db8a5bc0b26f
Established class (EPC) Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of action Non-Nucleoside Reverse Transcriptase Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-23
Route ORAL
Dosage form TABLET, FILM COATED
Substance DORAVIRINE; ISLATRAVIR ANHYDROUS

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

GPI-14 12109902650320
GCN Seq No 088879
GCN 59057
HICL code 051279
Ingredient (HICL) Doravirine/Islatravir
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5W
Therapeutic class — specific (HIC3) Artv-Nucleoside Analogs And Non-Nucleoside Rti Cmb
AHFS code 08:18.08.16
AHFS class Hiv Nonnucleoside Rev.transcrip. Inhib.
FDB label name IDVYNSO 100 MG-0.25 MG TABLET
FDB brand name Idvynso
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088879
  • GCN: 59057
  • GPI-14 (Medi-Span): 12109902650320
  • HICL (First Databank): 051279
  • AHFS class code: 08:18.08.16
  • RxCUI (RxNorm): 2741694
Why two NDCs? The FDA registers this code as 0006-5092-59 — a 4-4-2 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 labeler segment → 00006-5092-59. 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 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor class.

Pharmacologic class Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Drug family (ATC) Non-nucleoside reverse transcriptase inhibitors
How it works Non-Nucleoside Reverse Transcriptase 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 IDVYNSO 100 MG-0.25 MG TABLET Ingredient Doravirine/Islatravir

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 eachPer 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.
Try another pack size: 30 tablets
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
00006-5092-01 0006-5092-01 Main listing 30 TABLET, FILM COATED in 1 BOTTLE 2026-04-23 — Active
00006-5092-59 You're viewing this 14 TABLET, FILM COATED in 1 BOTTLE Sample 2026-04-23 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 14-count package — 14 tablet, film coated in 1 bottle.
How does this package differ from NDC 00006-5092-01?
Both are IDVYNSO Doravirine, Islatravir 100 mg; .25 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 14-count one, while NDC 00006-5092-01 is the 30 tablets package.
What NDC number is used to bill for this package of IDVYNSO Doravirine, Islatravir 100 mg; .25 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Idvynso 100 mg/1; .25 mgthis 00006-5092-59 Merck 14 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
First FDA approval
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🛡️
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 Aug 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 20, 2026 RLD RS ⏳ ~5.9 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 8486975 — drug substance (U-4527)
US 7339053 — drug substance
Exclusivity NCE
2026 2028 2030 2032
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 (2)
PatentTypeUse codeExpires
US 8486975 ↗ Drug substance U-4527 Aug 30, 2032
US 7339053 ↗ Drug substance — May 31, 2027
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Apr 20, 2031
Common questions
Is there a generic version of IDVYNSO 100 MG-0.25 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for IDVYNSO 100 MG-0.25 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Aug 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
ShapeOval
Imprint772;plain
Size17 mm
ScoringNot scored
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.

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

  • UNII H0G9379FGK
    Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • 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 36SFW2JZ0W
    Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII A7ZHS2RJ34
    A cellulose-derived polymer made by chemically modifying plant fiber. It acts as a film-former and enteric coating to protect medicine from stomach acid and control where it dissolves in the digestive tract.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 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 XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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.

Manufacturer & labeler

LabelerMerck Sharp & Dohme LLC
Application holderMERCK SHARP AND DOHME LLC
FDA applicationNDA216964 (NDA)
Labeler code00006
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio112 products on file

More NDCs from Merck Sharp & Dohme LLC labeler code 00006

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 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 152 words ▾

1 INDICATIONS AND USAGE IDVYNSO™ is indicated as a complete two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine [see Microbiology (12.4) and Clinical Studies (14) ]. IDVYNSO is a two-drug combination of doravirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), and islatravir, a nucleoside analog reverse transcriptase inhibitor (NRTI), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

( 1 )

⏱️ Dosage and Administration 141 words ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage: One tablet taken orally once daily with or without food in adults. ( 2.1 ) Dosage adjustment with rifabutin: Take one tablet of IDVYNSO once daily, followed by one tablet of doravirine (PIFELTRO) 100 mg approximately 12 hours after the dose of IDVYNSO. ( 2.2 )

2.1Recommended Dosage The recommended dosage of IDVYNSO is one tablet taken orally once daily with or without food [see Clinical Pharmacology (12.3) ] . One tablet of IDVYNSO contains 100 mg doravirine and 0.25 mg islatravir.

2.2Dosage Adjustment with Rifabutin If IDVYNSO is co-administered with rifabutin, take one tablet of IDVYNSO once daily as recommended, followed by one tablet of doravirine (PIFELTRO) 100 mg approximately 12 hours after the dose of IDVYNSO for the duration of rifabutin co-administration [see Drug Interactions (7.2) and Clinical Pharmacology (12.3) ].

💊 Dosage Forms and Strengths 46 words ▾

3 DOSAGE FORMS AND STRENGTHS IDVYNSO film-coated tablets are pink, oval-shaped, and debossed with 772 on one side and are plain on the other side. Each tablet contains 100 mg doravirine and 0.25 mg islatravir. Tablets: 100 mg doravirine and 0.25 mg islatravir. ( 3 )

⛔ Contraindications 155 words ▾

4 CONTRAINDICATIONS IDVYNSO is contraindicated when co-administered with: drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of IDVYNSO [see Warnings and Precautions (5.2) , Drug Interactions (7.2) , and Clinical Pharmacology (12.3) ] . lamivudine (3TC) or emtricitabine (FTC) as significant decreases in islatravir-triphosphate (ISL-TP) concentrations may occur, which may decrease the effectiveness of IDVYNSO [see Warnings and Precautions (5.2) , Drug Interactions (7.2) and Clinical Pharmacology (12.3) ] .

IDVYNSO is contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of IDVYNSO. ( 4 ) IDVYNSO is contraindicated when co-administered with lamivudine (3TC) or emtricitabine (FTC), which are deoxycytidine kinase (dCK) substrates, as a decrease in islatravir-triphosphate (ISL-TP) levels may occur, which may decrease the effectiveness of IDVYNSO. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Severe skin reactions, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), have been reported. Discontinue IDVYNSO immediately if signs or symptoms of severe skin reactions develop. ( 5.1 )

5.1Skin and Hypersensitivity Reactions Severe skin reactions, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported during postmarketing experience with doravirine-containing regimens [see Adverse Reactions (6.2) ] . In addition, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) was reported with IDVYNSO in a clinical trial [see Adverse Reactions (6.1) ] . Discontinue IDVYNSO, and other medications known to be associated with severe skin reactions, immediately if a painful rash with mucosal involvement, a progressive severe rash, or a rash with constitutional symptoms, eosinophilia, lymphadenopathy, or other organ involvement develops.

Clinical status should be closely monitored, and appropriate therapy should be initiated.

5.2Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions The concomitant use of IDVYNSO and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to [see Dosage and Administration (2.2) , Contraindications (4) , Drug Interactions (7.2) , and Clinical Pharmacology (12.3) ]: Loss of therapeutic effect of IDVYNSO and possible development of resistance. Possible clinically significant adverse reactions from greater exposures of a component of IDVYNSO .

See Table 3 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during IDVYNSO therapy, review concomitant medications during IDVYNSO therapy, and monitor for adverse reactions.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in other sections of the labeling: Skin and Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence greater than or equal to 2%, all grades): diarrhea, dizziness, fatigue, abdominal distension, headache, and weight increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 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 practice. Adverse Reactions in Virologically-Suppressed Adults Living with HIV-1 Who Switched to IDVYNSO The safety assessment of IDVYNSO in virologically-suppressed (HIV-1 RNA less than 50 copies/mL) participants living with HIV was based on Week 48 data from two Phase 3, randomized trials, Trial 051 and Trial 052.

A total of 708 participants received once-daily IDVYNSO [see Clinical Studies (14) ] . In Trial 051, an open-label trial with 551 participants, 366 participants were switched to IDVYNSO and 185 participants continued their baseline antiretroviral therapy (ART). By Week 48, 0.5% in the IDVYNSO group and 2% in the baseline ART group had adverse events leading to discontinuation of study medication.

In Trial 052, a double-blinded trial with 513 participants, 342 participants were switched to IDVYNSO and 171 participants continued on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). By Week 48, 3% in the IDVYNSO group and 2% in the BIC/FTC/TAF group had adverse events leading to discontinuation of study medication. Among participants who received IDVYNSO and experienced at least one adverse event in Trial 051 or Trial 052, 88% experienced only adverse events that were mild (Grade 1) or moderate (Grade 2).

The most common adverse reactions (all grades) reported in greater than or equal to 2% of participants in any treatment group from Trial 051 and Trial 052 through Week 48 are presented in Table 1 . Table 1: Adverse Reactions Frequencies based on all adverse events attributed to study drugs by the investigator (All Grades) Reported in ≥2% of Participants in Any Treatment Group in Trials 051 and 052 in HIV-1 Virologically-Suppressed Adults (Week 48) Adverse Reactions Trial 051 Trial 052 IDVYNSO N=366 Baseline ART N=185 IDVYNSO N=342 BIC/FTC/TAF N=171 Diarrhea 3% 0 1% 1% Dizziness 2% 1% 1% 0 Fatigue Fatigue includes fatigue and asthenia.

2% 1% 1% 1% Abdominal distension 2% 0 1% 0 Headache 2% 1% 1% 0 Weight increased The mean change in weight from baseline at Week 48 was 0.94 kg in the IDVYNSO group vs. -0.15 kg in the baseline ART group in Trial 051, and -0.03 kg in the IDVYNSO group vs. 0.28 kg in the BIC/FTC/TAF group in Trial 052. 2% 4 of the 6 participants with adverse reactions of weight increased switched from a baseline ART regimen containing efavirenz and/or tenofovir disoproxil fumarate in Trial 051.

0 <1% 0 A single case of severe immune thrombocytopenia (platelet count nadir of 2 x10 9 /L) characterized by abrupt onset of subcutaneous hematoma, petechiae, and hematuria was reported in a participant 32 days after initiating IDVYNSO in Trial 052. This serious adverse reaction resolved with discontinuation of IDVYNSO, in conjunction with treatments including corticosteroids and IVIG. Among all participants in Trial 051 and Trial 052, there were no patterns of platelet decreases over time with IDVYNSO and no differences between treatment arms in mean change from baseline in platelet count.

Less Common Adverse Reactions The following select adverse reactions were observed in less than 2% of participants administered IDVYNSO: Gastrointestinal disorders : Abdominal pain (includes abdominal pain, abdominal pain upper, a… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Because IDVYNSO is a complete regimen, co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended. ( 7.1 ) Consult the full prescribing information prior to and during treatment for important potential drug-drug interactions. ( 2.2 , 4 , 5.2 , 7 , 12.3 )

7.1Concomitant Use with Other Antiretroviral Medications Because IDVYNSO is a complete regimen for the treatment of HIV-1 infection, co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended.

7.2Effects of Other Drugs on IDVYNSO Doravirine Co-administration of IDVYNSO with a CYP3A inducer decreases doravirine plasma concentrations, which may reduce the efficacy of IDVYNSO [see Contraindications (4) , Warnings and Precautions (5.2) , and Clinical Pharmacology (12.3) ] . Co-administration of IDVYNSO and drugs that are inhibitors of CYP3A may result in increased plasma concentrations of doravirine. Islatravir Islatravir requires phosphorylation by cellular kinases to form the pharmacologically active ISL-TP.

Co-administration of IDVYNSO and drugs that are substrates of dCK (e.g., certain nucleoside antiviral agents and nucleoside antimetabolites) may result in a decrease in ISL-TP concentrations and may reduce the therapeutic effect of islatravir [see Contraindications (4) , Warnings and Precautions (5.2) , and Clinical Pharmacology (12.3) ] . Islatravir is subject to ADA-mediated metabolism (approximately 53%). Co-administration of IDVYNSO and drugs that are ADA inhibitors (e.g., pentostatin) may result in increased plasma concentrations of islatravir and may increase the risk of adverse reactions [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ] .

The drug interactions described in Table 3 are based on studies conducted with IDVYNSO, its components, or are predicted drug interactions that may occur with IDVYNSO. Table 3: Drug Interactions with IDVYNSO This table is not all inclusive. Concomitant Drug Class: Drug Name Effect on Concentration Clinical Comment ↑ = increase, ↓ = decrease Strong CYP3A Inducers ↓ doravirine Co-administration with strong CYP3A inducers is contraindicated At least a 4-week cessation period is recommended prior to initiation of IDVYNSO.

Moderate CYP3A Inducers ↓ doravirine If IDVYNSO is co-administered with rifabutin Interactions were evaluated in clinical studies. All other drug-drug interactions are predicted. , one tablet of doravirine (PIFELTRO) should be taken approximately 12 hours after the dose of IDVYNSO [see Dosage and Administration (2.2) ] . Co-administration with other moderate CYP3A inducers is not recommended. dCK Substrates May include other nucleoside drugs Anti-virals lamivudine emtricitabine ↓ ISL-TP Co-administration is contraindicated with lamivudine or emtricitabine.

Nucleoside Antimetabolites cladribine clofarabine cytarabine fludarabine gemcitabine ↓ ISL-TP Co-administration with these nucleoside antimetabolites is not recommended as dCK substrates may cause a decrease in the intracellular concentration of ISL-TP. ADA Inhibitors pentostatin ↑ islatravir Co-administration with pentostatin is not recommended as it may cause an increase in plasma concentrations of islatravir.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to IDVYNSO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary There are insufficient human data on the use of IDVYNSO during pregnancy to inform a drug-associated risk of birth defects and miscarriage.

In animal reproduction studies, no developmental effects were observed when the components of IDVYNSO were administered separately at exposures (AUC) at least 8 (doravirine) and 500 (islatravir) times the exposure at the recommended human dose (RHD) of these components in IDVYNSO (see Data .) The background rate of major birth defects is 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in the clinically recognized pregnancies in the U.S. general population is 15-20%.

Methodological limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates individuals and infants from the limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation. Data Animal Data Doravirine Doravirine was administered orally to pregnant rabbits (up to 300 mg/kg/day on Gestation Days (GD) 7 to 20) and rats (up to 450 mg/kg/day on GD 6 to 20 and separately from GD 6 to Lactation/Postpartum Day 20).

No significant toxicological effects on embryo-fetal (rats and rabbits) or pre/post-natal (rats) development were observed at exposures (AUC) approximately 9 times (rats) and 8 times (rabbits) the exposure in humans at the RHD. Doravirine was transferred to the fetus through the placenta in embryo-fetal studies, with fetal plasma concentrations of up to 40% (rabbits) and 52% (rats) that of maternal concentrations observed on GD 20. Islatravir Islatravir was administered orally to pregnant rabbits (up to 10 mg/kg/day on GD 7 to 20) and rats (up to 50 mg/kg/day on GD 6 to 20 and separately up to 10 mg/kg from GD 6 to Lactation/Postpartum Day 20).

No significant toxicological effects on embryo-fetal (rats and rabbits) or pre/post-natal (rats) development were observed at exposures (AUC) approximately 500 times (rats) and 1300 times (rabbits) the exposure in humans at the RHD. In rats, islatravir was transferred to the fetus through the placenta in rats, with fetal plasma concentrations of up to 88% that of maternal concentrations observed on GD 20.

8.2Lactation Risk Summary It is unknown whether IDVYNSO or any of the components of IDVYNSO is present in human milk, affects human milk production, or has effects on the breastfed infant. Doravirine is present in the milk of lactating rats, while islatravir was detected in the plasma of nursing pups from lactating rats administered islatravir ( see Data ). 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.

Data Doravirine: Doravirine was excreted into the milk of lactating rats following oral administration (450 mg/kg/day) from GD 6 to Lactation Day (LD) 14, with milk concentrations approximately 1.5 times that of maternal plasma concentrations observed 2 hours post dose on LD 14. Islatravir: Islatravir was detected in the plasma of nursing pups (LD 10) from lactating rats following oral administration (10 mg/kg) from GD 6 to LD 10, with concentrations 0.1% and 1.5% the maternal plasma concentrations observed 1 and 3 hours post dose on LD 10, respectively [see Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use The safety and effectiveness of IDVYNSO have not been established in pediatric patien… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to IDVYNSO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary There are insufficient human data on the use of IDVYNSO during pregnancy to inform a drug-associated risk of birth defects and miscarriage.

In animal reproduction studies, no developmental effects were observed when the components of IDVYNSO were administered separately at exposures (AUC) at least 8 (doravirine) and 500 (islatravir) times the exposure at the recommended human dose (RHD) of these components in IDVYNSO (see Data .) The background rate of major birth defects is 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in the clinically recognized pregnancies in the U.S. general population is 15-20%.

Methodological limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates individuals and infants from the limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation. Data Animal Data Doravirine Doravirine was administered orally to pregnant rabbits (up to 300 mg/kg/day on Gestation Days (GD) 7 to 20) and rats (up to 450 mg/kg/day on GD 6 to 20 and separately from GD 6 to Lactation/Postpartum Day 20).

No significant toxicological effects on embryo-fetal (rats and rabbits) or pre/post-natal (rats) development were observed at exposures (AUC) approximately 9 times (rats) and 8 times (rabbits) the exposure in humans at the RHD. Doravirine was transferred to the fetus through the placenta in embryo-fetal studies, with fetal plasma concentrations of up to 40% (rabbits) and 52% (rats) that of maternal concentrations observed on GD 20. Islatravir Islatravir was administered orally to pregnant rabbits (up to 10 mg/kg/day on GD 7 to 20) and rats (up to 50 mg/kg/day on GD 6 to 20 and separately up to 10 mg/kg from GD 6 to Lactation/Postpartum Day 20).

No significant toxicological effects on embryo-fetal (rats and rabbits) or pre/post-natal (rats) development were observed at exposures (AUC) approximately 500 times (rats) and 1300 times (rabbits) the exposure in humans at the RHD. In rats, islatravir was transferred to the fetus through the placenta in rats, with fetal plasma concentrations of up to 88% that of maternal concentrations observed on GD 20.

🧒 Pediatric Use 27 words ▾

8.4Pediatric Use The safety and effectiveness of IDVYNSO have not been established in pediatric patients less than 18 years of age [see Clinical Pharmacology (12.3) ].

🧓 Geriatric Use 65 words ▾

8.5Geriatric Use Clinical trials in virologically-suppressed participants who received IDVYNSO (Trial 051 and Trial 052) included 81 (11%) participants aged 65 years and older, including 10 (1%) aged 75 years and older [see Clinical Studies (14) ] . No overall differences in safety or effectiveness were observed between these participants and younger participants, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 36 words ▾

10 OVERDOSAGE No data are available on overdose of IDVYNSO and there is no known specific treatment for overdose with IDVYNSO. If overdose occurs, the person should be monitored, and standard supportive treatment applied as required.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action IDVYNSO is a fixed-dose combination of the antiretroviral drugs doravirine and islatravir [see Microbiology (12.4) ].

12.2Pharmacodynamics In a Phase 2 trial evaluating doravirine over a dose range of 0.25 to 2 times the recommended dose of doravirine (in combination with FTC and TDF), in participants with no antiretroviral treatment history, no exposure-response relationship for efficacy was identified for doravirine. In a Phase 2 trial evaluating islatravir over a dose range of 1 to 9 times the recommended dose of islatravir (in combination with doravirine and 3TC), in participants with no antiretroviral treatment history, no exposure-response relationship for efficacy was identified for islatravir.

Exposure-response modeling of data from Phase 2 and Phase 3 studies, including studies evaluating islatravir at daily doses from 0.25 mg to 2.25 mg (9 times the recommended daily dosage), demonstrated a relationship between islatravir exposure and decreases in lymphocytes and CD4+ T-cells. No clinically meaningful reduction in lymphocytes or CD4+ T-cells was observed at exposures associated with the recommended daily islatravir dose of 0.25 mg. Cardiac Electrophysiology At 12 times the maximum recommended doravirine dose, clinically significant QTc interval prolongation was not observed.

At 960 times the maximum recommended islatravir dose, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics Single-dose administration of one IDVYNSO tablet to healthy adult participants under fasted conditions provided comparable exposures of doravirine and islatravir to administration of a doravirine tablet (100 mg) plus an islatravir capsule (0.25 mg). No clinically significant difference in pharmacokinetics was observed between healthy participants and participants living with HIV-1. Plasma pharmacokinetic properties of the components of IDVYNSO are provided in Table 4 .

Table 4: Pharmacokinetic Properties of the Components of IDVYNSO Parameter Doravirine Islatravir Abbreviations: AUC=area under the time concentration curve; C max =maximum concentration; C 24 =concentration at 24 hours; T max =time to C max ; Vd/F=apparent volume of distribution; t 1/2 =half-life; CL/F=apparent clearance; ADA= adenosine deaminase General Steady State Exposure AUC 0-24 Reported as geometric mean (%CV: geometric coefficient of variation) 37.8 (29) μM•hr Doravirine 100 mg once daily to participants living with HIV 31.4 (15.3) nM•hr IDVYNSO once daily to participants living with HIV C max 2.26 (19) μM 3.45 (5.5) nM C 24 0.930 (63) μM 0.779 (22.3) nM Time to Steady State (d) 2 7 Accumulation Ratio 1.2 to 1.4

1.8Absorption Absolute Bioavailability 64% unknown T max (hr) Under fasted conditions 4 1 Effect of Food Geometric mean ratio [high-fat meal/fasting] and (90% confidence interval) for pharmacokinetic parameters. High fat meal is approximately 1000 kcal, 50% fat. The effect of food is not clinically relevant.

AUC Ratio 1.17 (1.10, 1.24) 1.13 (1.07, 1.19) C max Ratio 1.18 (1.11, 1.25) 0.80 (0.71, 0.91) Distribution V d /F (L) Based on population pharmacokinetic modeling and reported as the population mean (%CV) 162 (32.6) 264 Plasma protein binding 76% 3% Elimination t 1/2 (h) 15 21 Reported as the effective half-life of islatravir. The terminal half-life of islatravir is approximately 230 hours. The terminal half-life of intracellular ISL-TP is approximately 186 hours.

CL/F (L/hr) 6.34 (35.2) 27.7 (15.1) Metabolism Primary Pathway(s) CYP3A Oxidative deamination by ADA Excretion Major route of elimination Metabolism Metabolism Urine (unchanged) 6% 32% Biliary/Fecal (unchanged) Minor Minor Specific Populations No clinically significant differences in the pharmacokinetics of doravirine were observed based on age (18 to 78 years), sex, race/ethnicity (White, Black or African American, Asian, and other), mild to severe renal impairment (creatinine clearance (CLcr) > 15 mL/min), an… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 20 words ▾

12.1Mechanism of Action IDVYNSO is a fixed-dose combination of the antiretroviral drugs doravirine and islatravir [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling 96 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Each IDVYNSO tablet contains 100 mg of doravirine and 0.25 mg of islatravir, is pink, oval-shaped and film-coated, and is debossed with 772 on one side and plain on the other side. Each bottle contains 30 tablets (NDC 0006-5092-01) with desiccant and is closed with a child-resistant closure. Store IDVYNSO in the original bottle.

Keep the bottle tightly closed to protect from moisture. Do not remove the desiccant. Store IDVYNSO at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description 202 words ▾

11 DESCRIPTION IDVYNSO is a fixed-dose combination tablet for oral administration containing doravirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), and islatravir, an HIV-1 nucleoside analog reverse transcriptase inhibitor (NRTI). Each film-coated tablet contains 100 mg of doravirine and 0.25 mg islatravir as active ingredients. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

The tablets are film coated with a coating material containing the following inactive ingredients: calcium carbonate, ferric oxide, ferrosoferric oxide, hypromellose, lactose monohydrate, and triacetin. The coated tablets are polished with carnauba wax. Doravirine The chemical name for doravirine is 3-chloro-5-[[1-[(4,5-dihydro-4-methyl-5-oxo-1 H -1,2,4-triazol-3-yl)methyl]-1,2-dihydro-2-oxo-4-(trifluoromethyl)-3-pyridinyl]oxy]benzonitrile.

The molecular formula is C 17 H 11 ClF 3 N 5 O 3 and the molecular weight is 425.75. Doravirine is practically insoluble in water and has the following structural formula: Islatravir Islatravir is a crystalline monohydrate. The chemical name for islatravir is 2′-deoxy-4′- C -ethynyl-2-fluoroadenosine hydrate (1:1).

The molecular formula is C 12 H 12 FN 5 O 3 .H 2 O and the molecular weight is 311.27. Islatravir monohydrate is very slightly soluble in water and has the following structural formula: Chemical Structure - Doravirine Chemical Structure - Islatravir

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling ( Patient Information ). Skin and Hypersensitivity Reactions Inform patients that severe skin reactions including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported with doravirine-containing regimens. Advise patients to immediately contact their healthcare provider if they develop a rash.

Instruct patients to immediately stop taking IDVYNSO and seek medical attention if a painful rash with mucosal involvement or a rash with constitutional symptoms develops [see Warnings and Precautions (5.1) ] . Drug Interactions Inform patients that IDVYNSO may interact with certain other drugs; therefore, 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 [see Contraindications (4) , Warnings and Precautions (5.2) , and Drug Interactions (7.2) ].

For patients concomitantly receiving rifabutin, take one tablet of doravirine (PIFELTRO) 100 mg approximately 12 hours after the dose of IDVYNSO [see Dosage and Administration (2.2) ] . Dosing Instructions Advise patients to take IDVYNSO every day at a regularly scheduled time with or without food. Inform patients that it is important not to miss or skip doses as it can result in development of resistance.

If patients forget to take IDVYNSO, tell patients to take the missed dose right away, unless it is almost time for the next dose [see Dosage and Administration (2.1) ] . Pregnancy Registry Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes in pregnant individuals exposed to IDVYNSO [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) ] .

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Single-dose administration of one IDVYNSO tablet to healthy adult participants under fasted conditions provided comparable exposures of doravirine and islatravir to administration of a doravirine tablet (100 mg) plus an islatravir capsule (0.25 mg). No clinically significant difference in pharmacokinetics was observed between healthy participants and participants living with HIV-1. Plasma pharmacokinetic properties of the components of IDVYNSO are provided in Table 4 .

Table 4: Pharmacokinetic Properties of the Components of IDVYNSO Parameter Doravirine Islatravir Abbreviations: AUC=area under the time concentration curve; C max =maximum concentration; C 24 =concentration at 24 hours; T max =time to C max ; Vd/F=apparent volume of distribution; t 1/2 =half-life; CL/F=apparent clearance; ADA= adenosine deaminase General Steady State Exposure AUC 0-24 Reported as geometric mean (%CV: geometric coefficient of variation) 37.8 (29) μM•hr Doravirine 100 mg once daily to participants living with HIV 31.4 (15.3) nM•hr IDVYNSO once daily to participants living with HIV C max 2.26 (19) μM 3.45 (5.5) nM C 24 0.930 (63) μM 0.779 (22.3) nM Time to Steady State (d) 2 7 Accumulation Ratio 1.2 to 1.4

1.8Absorption Absolute Bioavailability 64% unknown T max (hr) Under fasted conditions 4 1 Effect of Food Geometric mean ratio [high-fat meal/fasting] and (90% confidence interval) for pharmacokinetic parameters. High fat meal is approximately 1000 kcal, 50% fat. The effect of food is not clinically relevant.

AUC Ratio 1.17 (1.10, 1.24) 1.13 (1.07, 1.19) C max Ratio 1.18 (1.11, 1.25) 0.80 (0.71, 0.91) Distribution V d /F (L) Based on population pharmacokinetic modeling and reported as the population mean (%CV) 162 (32.6) 264 Plasma protein binding 76% 3% Elimination t 1/2 (h) 15 21 Reported as the effective half-life of islatravir. The terminal half-life of islatravir is approximately 230 hours. The terminal half-life of intracellular ISL-TP is approximately 186 hours.

CL/F (L/hr) 6.34 (35.2) 27.7 (15.1) Metabolism Primary Pathway(s) CYP3A Oxidative deamination by ADA Excretion Major route of elimination Metabolism Metabolism Urine (unchanged) 6% 32% Biliary/Fecal (unchanged) Minor Minor Specific Populations No clinically significant differences in the pharmacokinetics of doravirine were observed based on age (18 to 78 years), sex, race/ethnicity (White, Black or African American, Asian, and other), mild to severe renal impairment (creatinine clearance (CLcr) > 15 mL/min), and mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.

The pharmacokinetics of doravirine in patients with end-stage renal disease or undergoing dialysis, or severe hepatic impairment (Child-Pugh C) is unknown. No clinically significant differences in the pharmacokinetics of islatravir were observed based on age (18 to 83 years), weight (36.6 to 205.3 kg), sex, race/ethnicity (White, Black or African American, Asian, and other), mild to moderate renal impairment (eGFR ≥30 mL/min/1.73 m 2 ), and mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.

The pharmacokinetics of islatravir in patients undergoing dialysis, patients with severe hepatic impairment (Child-Pugh Class C), or people <18 years of age is unknown. Patients with Renal Impairment Islatravir : In a study comparing 6 participants with severe renal impairment (eGFR < 30 mL/min/1.73 m 2 , not on dialysis) to 6 participants without renal impairment, the single dose exposure of islatravir was approximately 2-fold higher in participants with severe renal impairment [see Use in Specific Populations (8.6) ] .

Drug Interaction Studies As IDVYNSO is a complete regimen for the treatment of HIV-1 infection, it is not recommended to be administered with other HIV-1 antiretroviral medications. Doravirine Doravirine is primarily metabolized by CYP3A, and drugs that induce or inhibit CYP3A may affect the clearance of doravirine. Co-administration of doravir… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 188 words ▾

12.2Pharmacodynamics In a Phase 2 trial evaluating doravirine over a dose range of 0.25 to 2 times the recommended dose of doravirine (in combination with FTC and TDF), in participants with no antiretroviral treatment history, no exposure-response relationship for efficacy was identified for doravirine. In a Phase 2 trial evaluating islatravir over a dose range of 1 to 9 times the recommended dose of islatravir (in combination with doravirine and 3TC), in participants with no antiretroviral treatment history, no exposure-response relationship for efficacy was identified for islatravir.

Exposure-response modeling of data from Phase 2 and Phase 3 studies, including studies evaluating islatravir at daily doses from 0.25 mg to 2.25 mg (9 times the recommended daily dosage), demonstrated a relationship between islatravir exposure and decreases in lymphocytes and CD4+ T-cells. No clinically meaningful reduction in lymphocytes or CD4+ T-cells was observed at exposures associated with the recommended daily islatravir dose of 0.25 mg. Cardiac Electrophysiology At 12 times the maximum recommended doravirine dose, clinically significant QTc interval prolongation was not observed.

At 960 times the maximum recommended islatravir dose, clinically significant QTc interval prolongation was not observed.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of IDVYNSO is supported by data from 2 randomized, active-controlled, non-inferiority trials (Trial 051 [NCT05631093] and Trial 052 [NCT05630755]) in virologically-suppressed (HIV-1 RNA less than 50 copies per mL) participants living with HIV. Participants must have been stably suppressed on their baseline regimen for at least 3 months prior to trial entry and had no history of treatment failure. Participants with active HBV infection [hepatitis B surface antigen (HBsAg) positive or HBV DNA positive] were excluded from the trials.

In open-labeled Trial 051, participants switched from an oral ART regimen to IDVYNSO. A total of 551 participants were randomized (2:1) and switched to once-daily IDVYNSO (N=366) or remained on their baseline ART (N=185). Randomization was stratified by baseline ART.

At baseline, participants had a mean age of 50 years (range: 18 to 83), 60% of participants were male, 39% were White, 45% were Black/African American, 5% were Asian, and 11% were other or unknown. A total of 15% identified as Hispanic/Latino. The mean baseline CD4+ T-cell count was 748 cells/mm 3 and 80% of participants had baseline CD4+ T-cell count >500 cells/mm 3 .

At enrollment, 64% of the participants were receiving InSTI-based regimens, 5% PI-based regimens (including combinations with InSTI), and 30% other regimens. Approximately 29% of participants in both study arms had evidence of past HBV infection [hepatitis B core antibody (HBcAb) positive] at enrollment. These characteristics were similar between treatment groups.

In the double-blind Trial 052, participants switched from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) to IDVYNSO. A total of 513 participants were randomized (2:1) and switched to once-daily IDVYNSO (N=342) or remained on BIC/FTC/TAF (N=171). At baseline, participants had a mean age of 48 years (range: 19 to 77), 79% of participants were male, 61% were White, 31% were Black/African American, 6% were Asian, and 3% were other or unknown.

A total of 23% identified as Hispanic/Latino. The mean baseline CD4+ T-cell count was 717 cells/mm 3 and 75% of participants had baseline CD4+ T-cell count >500 cells/mm 3 . Approximately 26% of participants in both study arms were HBcAb positive at enrollment.

These characteristics were similar between treatment groups. The primary endpoint of Trial 051 and Trial 052 was the proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48. Treatment outcomes are shown in Table 7 .

Table 7: Virologic Outcomes in Trial 051 and Trial 052 at Week 48 in Virologically-Suppressed Adults Who Switched to IDVYNSO Outcomes Trial 051 Trial 052 IDVYNSO N=366 Baseline ART N=185 IDVYNSO N=342 BIC/FTC/TAF N=171 HIV-1 RNA ≥50 copies/mL 1% 5% 1% 1% Treatment Difference (95% CI) CIs were calculated based on the stratified Miettinen and Nurminen method with Cochran-Mantel-Haenszel weights for Trial 051 (with baseline ART as stratification factors), and unstratified Miettinen and Nurminen method for Trial 052; non-inferiority (NI) was assessed using a NI margin of 4% -3.6% (-7.8%, -0.8%) 0.9% (-1.9%, 2.9%) HIV-1 RNA <50 copies/mL 96% 92% 92% 94% No Virologic Data at Week 48 Window 3% 3% 7% 5% Discontinued study due to AE or Death Includes participants who discontinued because of AE or death if this resulted in no virologic data on treatment during the Week 48 window 1% 1% 2% 2% Discontinued study for Other Reasons Other reasons include: lost to follow-up, physician decision, and withdrawal by participant 2% 2% 5% 4% On study drug but missing data in window 1% 1% - - In Trial 051, treatment outcomes between treatment groups were similar across subgroups by age, sex, race and baseline ART regimens.

In Trial 052, treatment outcomes between treatment groups were similar across subgroups by age, sex and race. In Trial 051, the mean increase from baseline at Week 48 in CD4+ T-cell counts in the IDVYNSO and baseline ART groups were 5 and 18 cells/mm 3 , re… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Doravirine Doravirine was not carcinogenic in a 6-month transgenic mouse study at doses of up to 300 mg/kg/day or in a 2-year rat oral carcinogenicity study at exposures up to 7 times the human exposures at the RHD. A statistically significant incidence of thyroid parafollicular cell adenoma and carcinoma seen only in female rats at the high dose was within the range observed in historical controls. Islatravir Islatravir was not carcinogenic in a 6-month transgenic mouse study at doses of up to 13 mg/kg/day or in a 2-year rat oral carcinogenicity study at exposures approximately 600 times the human exposures at the RHD.

Mutagenesis Doravirine Doravirine was not genotoxic in a battery of in vitro or in vivo assays, including microbial mutagenesis, chromosomal aberration in Chinese hamster ovary cells, and in in vivo rat micronucleus assays. Islatravir Islatravir was not mutagenic in the in vitro microbial mutagenicity assay. Islatravir was positive in an in vitro chromosomal aberration assay in Chinese hamster ovary cells likely due to nucleotide pool imbalances; however, it was not genotoxic in an in vivo rat micronucleus assay at systemic exposures (AUC) approximately 2700 times the human exposure at the RHD.

Islatravir is not genotoxic at clinically relevant exposures. Impairment of Fertility Doravirine There were no effects on fertility, mating performance, or early embryonic development when doravirine was administered to rats at systemic exposures (AUC) approximately 7 times the exposure in humans at the RHD. Islatravir There were no effects on fertility, mating performance, or early embryonic development when islatravir was administered to rats at systemic exposures (AUC) approximately 1000 times the exposure in humans at the RHD.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Doravirine Doravirine was not carcinogenic in a 6-month transgenic mouse study at doses of up to 300 mg/kg/day or in a 2-year rat oral carcinogenicity study at exposures up to 7 times the human exposures at the RHD. A statistically significant incidence of thyroid parafollicular cell adenoma and carcinoma seen only in female rats at the high dose was within the range observed in historical controls. Islatravir Islatravir was not carcinogenic in a 6-month transgenic mouse study at doses of up to 13 mg/kg/day or in a 2-year rat oral carcinogenicity study at exposures approximately 600 times the human exposures at the RHD.

Mutagenesis Doravirine Doravirine was not genotoxic in a battery of in vitro or in vivo assays, including microbial mutagenesis, chromosomal aberration in Chinese hamster ovary cells, and in in vivo rat micronucleus assays. Islatravir Islatravir was not mutagenic in the in vitro microbial mutagenicity assay. Islatravir was positive in an in vitro chromosomal aberration assay in Chinese hamster ovary cells likely due to nucleotide pool imbalances; however, it was not genotoxic in an in vivo rat micronucleus assay at systemic exposures (AUC) approximately 2700 times the human exposure at the RHD.

Islatravir is not genotoxic at clinically relevant exposures. Impairment of Fertility Doravirine There were no effects on fertility, mating performance, or early embryonic development when doravirine was administered to rats at systemic exposures (AUC) approximately 7 times the exposure in humans at the RHD. Islatravir There were no effects on fertility, mating performance, or early embryonic development when islatravir was administered to rats at systemic exposures (AUC) approximately 1000 times the exposure in humans at the RHD.

📄 Patient Package Insert ~3 min read ▾

Patient Information IDVYNSO ™ (ihd‑VIHN‑soh) (doravirine and islatravir) tablets This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 04/2026 What is IDVYNSO? IDVYNSO is a prescription medicine that is used without other Human Immunodeficiency Virus-1 (HIV-1) medicines to treat HIV-1 infection in adults to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). IDVYNSO contains the prescription medicines doravirine and islatravir. It is not known if IDVYNSO is safe and effective in children under 18 years of age.

Do not take IDVYNSO if you take: certain medicines called strong CYP3A inducers which increase the enzyme CYP3A in your liver. lamivudine or emtricitabine. These medicines can make IDVYNSO less effective. Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are strong CYP3A inducers.

If you have taken any of the medicines in the past 4 weeks, talk to your healthcare provider or pharmacist before starting treatment with IDVYNSO. Before taking IDVYNSO, tell your healthcare provider about all of your medical conditions, including if you: have liver problems have ever had hepatitis B virus infection have kidney problems are pregnant or plan to become pregnant. It is not known if IDVYNSO can harm your unborn baby.

Tell your healthcare provider if you become pregnant during treatment with IDVYNSO. Pregnancy Registry: There is a pregnancy registry for people who take IDVYNSO during pregnancy. The purpose of this registry is to collect information about the health of you and your baby.

Talk to your healthcare provider about how you can take part in this registry. are breastfeeding or plan to breastfeed. It is not known if IDVYNSO passes into your breast milk. Talk with your healthcare provider about the following risks to your baby from breastfeeding during treatment with IDVYNSO: the HIV-1 virus may pass to your baby if your baby does not have HIV-1. the HIV-1 virus may become harder to treat if your baby has HIV-1. your baby may get side effects from IDVYNSO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with IDVYNSO. Keep a list of your medicines to show your healthcare provider and pharmacist.

Tell your healthcare provider if you have taken rifabutin in the past 4 weeks. You can ask your healthcare provider or pharmacist for a list of medicines that interact with IDVYNSO. Do not start taking a new medicine without telling your healthcare provider.

Your healthcare provider can tell you if it is safe to take IDVYNSO with other medicines. How should I take IDVYNSO? Take IDVYNSO every day exactly as your healthcare provider tells you to take it.

Take IDVYNSO 1 time each day, at about the same time every day. Take IDVYNSO with or without food. IDVYNSO is taken by itself (without other HIV-1 medicines).

If you take the medicine rifabutin during treatment with IDVYNSO, your healthcare provider will also prescribe an additional dose of doravirine for you. You may not have enough doravirine in your blood if you take rifabutin during treatment with IDVYNSO. Carefully follow your healthcare provider’s instructions about when to take doravirine and how much to take.

This is usually 1 tablet of doravirine about 12 hours after your dose of IDVYNSO. Do not change your dose or stop taking IDVYNSO without talking to your healthcare provider. Stay under a healthcare provider’s care when taking IDVYNSO.

It is important that you do not miss or skip doses of IDVYNSO. If you miss a dose of IDVYNSO, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose, and take the next dose at your regular time.

Do not take 2 doses of IDVYNSO at the same time. If you have any qu… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 45 words ▾

PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label NDC 0006-5092-01 Idvynso ™ (doravirine and islatravir) tablets 100 mg/0.25 mg ALERT: Find out about medicines that should NOT be taken with Idvynso ™ . Rx only 30 Tablets PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

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

About this NDC listing & data coverage

Finished prescription product
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Active ingredient / dosage form / route ✓ Available
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Inactive ingredients (structured) ✓ Available
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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.
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Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (00006-5092-01). Each has its own NDC and its own page — see the package list near the top of this page.
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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.
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← 00006-5091-01 · Merck 00006-5331-01 · Merck →
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.