Each PIFELTRO tablet contains 100 mg of doravirine, is white, oval-shaped and film-coated, and is debossed with the corporate logo and 700 on one side and plain on the other side. Each bottle contains 30 tablets (NDC 0006-3069-01) with silica gel desiccant and is closed with a child-resistant closure.
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) [see USP Controlled Room Temperature]. These highlights do not include all the information needed to use PIFELTRO safely and effectively. See full prescribing information for PIFELTRO.
PIFELTRO� (doravirine) tablets, for oral use
Initial U.S. Approval: 2018
RECENT MAJOR CHANGES
Indications and Usage (1) 09/2019
Warnings and Precautions,
Immune Reconstitution Syndrome (5.2) 09/2019
INDICATIONS AND USAGE
PIFELTRO, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients:
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. (1)
DOSAGE AND ADMINISTRATION
Recommended dosage: One tablet taken orally once daily with or without food in adult patients. (2.1)
Dosage adjustment with rifabutin: One tablet taken twice daily (approximately 12 hours apart). (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg doravirine. (3)
CONTRAINDICATIONS
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. (4)
WARNINGS AND PRECAUTIONS
Monitor for Immune Reconstitution Syndrome. (5.2)
ADVERSE REACTIONS
Most common adverse reactions (incidence greater than or equal to 5%, all grades) are nausea, dizziness, headache, fatigue, diarrhea, abdominal pain, and abnormal dreams. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Consult the full prescribing information prior to and during treatment for important potential drug-drug interactions. (4, 5.1, 7)
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2019