"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
STRIBILD® is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of STRIBILD [see Clinical Studies].
DOSAGE AND ADMINISTRATION
The recommended dosage of STRIBILD is one tablet taken orally once daily with food [see CLINICAL PHARMACOLOGY].
Dosage Adjustment In Patients With Renal Impairment
Initiation of STRIBILD in patients with estimated creatinine clearance below 70 mL per minute is not recommended. Because STRIBILD is a fixed-dose combination tablet, STRIBILD should be discontinued if estimated creatinine clearance declines below 50 mL per minute during treatment with STRIBILD, as the dose interval adjustment required for emtricitabine and tenofovir disoproxil fumarate (DF) cannot be achieved [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, Use in Specific Populations, CLINICAL PHARMACOLOGY, and Clinical Studies].
Dosage In Patients With Hepatic Impairment
No dosage 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].
Testing Prior To Initiation Of STRIBILD
Prior to initiation of STRIBILD, patients should be tested for hepatitis B infection [see WARNINGS AND PRECAUTIONS] and estimated creatinine clearance, urine glucose and urine protein should be documented in all patients [see WARNINGS AND PRECAUTIONS].
Dosage Forms And Strengths
Each STRIBILD 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  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. Revised: December 2014
Last reviewed on RxList: 1/2/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Stribild Information
- Stribild Drug Interactions Center: elvitegr-cobicist-emtric-tenof oral
- Stribild Side Effects Center
- Stribild FDA Approved Prescribing Information including Dosage
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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