Brand Name
Idvynso
Generic Name
Islatravir
View Brand Information FDA approval date: April 20, 2026
Classification: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Form: Tablet
What is Idvynso (Islatravir)?
IDVYNSO™ is indicated as a complete two-drug regimen for the treatment of human immunodeficiency virus type 1 infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine [see Microbiology (1.
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Brand Information
IDVYNSO (Doravirine, Islatravir)
1INDICATIONS 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
2DOSAGE 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.
3CONTRAINDICATIONS
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
- lamivudine (3TC) or emtricitabine (FTC) as significant decreases in islatravir-triphosphate (ISL-TP) concentrations may occur, which may decrease the effectiveness of IDVYNSO
4ADVERSE REACTIONS
The following serious adverse reactions are described in greater detail in other sections of the labeling:
- Skin and Hypersensitivity Reactions
4.1Clinical 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
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
A single case of severe immune thrombocytopenia (platelet count nadir of 2 x10
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, abdominal pain lower, and abdominal discomfort), flatulence, nausea
- Psychiatric disorders: Abnormal dreams, Insomnia (includes insomnia, initial insomnia, middle insomnia and terminal insomnia)
- Skin and Subcutaneous Tissue Disorders: Pruritus, Rash (includes rash, rash papular, rash maculo-papular and rash pruritic)
In an ongoing clinical trial, a participant developed Grade 4 DRESS syndrome ten weeks after starting IDVYNSO that was characterized by a diffuse pruritic maculopapular rash covering 60% of the body, lymphadenopathy, eosinophilia (peak 20,000 cells/µL), and an episode of hypotension. This serious adverse reaction resolved with discontinuation of IDVYNSO
Laboratory Abnormalities
Hepatic laboratory data from Trials 051 and Trial 052 are presented in
Across the clinical development program for the combination of doravirine and islatravir, there were 3 participants with elevations in alanine aminotransferase and/or aspartate aminotransferase greater than 10X ULN attributed to study drug that resolved with discontinuation of treatment. Of the 3 participants, one received doravirine 100 mg with islatravir 0.75 mg (three times the recommended dosage of islatravir) and had transient elevation in total bilirubin 2X ULN and Grade 1 (mild) nausea. The other 2 participants received IDVYNSO and were asymptomatic.
4.2Postmarketing Experience
The following adverse reactions have been identified during postmarketing experience in patients receiving doravirine-containing regimens. 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.
Doravirine:
Hepatobiliary Disorders: hepatitis
Investigations: hepatic enzyme increased
Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)
5OVERDOSAGE
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.
6DESCRIPTION
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
Islatravir
Islatravir is a crystalline monohydrate. The chemical name for islatravir is 2′-deoxy-4′-
7CLINICAL 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
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
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
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
8HOW 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].
9PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (
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
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
For patients concomitantly receiving rifabutin, take one tablet of doravirine (PIFELTRO) 100 mg approximately 12 hours after the dose of IDVYNSO
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
Pregnancy Registry
Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes in pregnant individuals exposed to IDVYNSO
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
10PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
NDC 0006-5092-01
Idvynso
100 mg/0.25 mg
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Rx only
30 Tablets
