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Stribild

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Stribild

INDICATIONS

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

Dosage Information

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 min during treatment with STRIBILD as 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].

HOW SUPPLIED

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 (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: October 2013

Last reviewed on RxList: 10/21/2013
This monograph has been modified to include the generic and brand name in many instances.

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