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STRIBILD™ is indicated as a complete regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-na´ve.
DOSAGE AND ADMINISTRATION
The recommended dose of STRIBILD is one tablet taken orally once daily with food [See CLINICAL PHARMACOLOGY].
STRIBILD should not be initiated in patients with estimated creatinine clearance below 70 mL per min. Because STRIBILD is a fixed-dose combination tablet, STRIBILD should be discontinued if estimated creatinine clearance declines below 50 mL per min during treatment with STRIBILD as dose interval adjustment required for emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) cannot be achieved [See WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, Use in Specific Populations, CLINICAL PHARMACOLOGY, and Clinical Studies].
No dose adjustment of STRIBILD is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. No pharmacokinetic or safety data are available regarding the use of STRIBILD in patients with severe hepatic impairment (Child-Pugh Class C). Therefore, STRIBILD is not recommended for use in patients with severe hepatic impairment [See Use In Specific Populations and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
STRIBILD is available as tablets. Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate (tenofovir DF, equivalent to 245 mg of tenofovir disoproxil).
The tablets are green, capsule-shaped, film-coated, debossed with “GSI” on one side and the number “1” surrounded by a square box (1) on the other side of the tablet.
Storage And Handling
STRIBILD tablets are green, capsule-shaped, film-coated, debossed with “GSI” on one side and the number “1” surrounded by a square box (1) on the other side. Each bottle contains 30 tablets (NDC 61958-1201-1), a silica gel desiccant and closed with a child-resistant closure.
Store at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (see USP Controlled Room Temperature).
- Keep container tightly closed.
- Dispense only in original container.
- Do not use if seal over bottle opening is broken or missing.
Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404. Issued: August 2012
Last reviewed on RxList: 9/20/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Stribild Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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