Usual Adult Dose for HIV Infection

100 mg orally once a day

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in patients: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to this drug

Usual Pediatric Dose for HIV Infection

At least 35 kg: 100 mg orally once a day

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in patients: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to this drug

Renal Dose Adjustments

Mild, moderate, or severe renal dysfunction: No adjustment recommended.
ESRD: Data not available

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Data not available

Dose Adjustments

Coadministration with rifabutin: Doravirine 100 mg orally twice a day

Comments:

• Dosing should be about 12 hours apart.
• Increased dosing should continue for the duration of rifabutin coadministration.

Precautions

CONTRAINDICATIONS:
Coadministration with strong CYP450 3A inducers (may significantly decrease doravirine plasma levels, which may decrease the efficacy of this drug) including, but not limited to, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St. John's wort

Safety and efficacy have not been established in pediatric patients weighing less than 35 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer with or without food.

• Store at 20 to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Store in original bottle and do not remove desiccant; keep bottle tightly closed to protect from moisture.

• Read the US FDA-approved patient labeling (Patient Information).
• Notify healthcare provider at once of any symptoms of infection.
• Do not miss or skip doses as resistance may develop.
• If a dose is missed, take it as soon as remembered unless it is almost time for the next dose, then skip the missed dose and take the next dose at the regularly scheduled time. Do not take 2 doses at the same time.

Frequently asked questions

• What drugs are contained in the HIV treatment Delstrigo?
• What type of drug is Pifeltro (doravirine)?