Doravirine

What it is used for

PIFELTRO ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg:

• with no prior antiretroviral treatment history; OR
• 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 treatment failure and no known substitutions associated with resistance to doravirine.

Side effects, and when to stop

The following adverse reactions are discussed in other sections of the labeling:

• Skin and Hypersensitivity Reactions
• Immune Reconstitution Syndrome

Who should not take it

PIFELTRO 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 PIFELTRO. These drugs include, but are not limited to, the following:

• the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• the androgen receptor inhibitor enzalutamide
• the antimycobacterials rifampin, rifapentine
• the cytotoxic agent mitotane
• St. John's wort ( Hypericum perforatum)

Storing it

Store PIFELTRO in the original bottle. Keep the bottle tightly closed to protect from moisture. Do not remove the desiccant.

Store PIFELTRO at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).