Overview
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.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action IDVYNSO is a fixed-dose combination of the antiretroviral drugs doravirine and islatravir [see Microbiology (12.4) ]. 12.2 Pharmacodynamics 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.
Indications
- 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) ].
Common Doses
- 100 mg
- 0.25 mg
Dosage
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 ) 2.1 Recommended 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.
Contraindications
- 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.
Side Effects
- 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.
Interactions
- 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 ) 7.1 Concomitant 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.