Doravirine (3 brand names, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- DELSTRIGO
- IDVYNSO
- PIFELTRO
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)].
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)].
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)]
Mechanism of Action
IDVYNSO is a fixed-dose combination of the antiretroviral drugs doravirine and islatravir [see Microbiology (12.4)].
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.