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GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(三)
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Description of Clinical Trials
14.2 Clinical Trial Results in HIV-1 Treatment-Naïve Subjects
14.3 Clinical Trial Results in HIV-1 Virologically-Suppressed Subjects Who Switched to GENVOYA
14.4 Clinical Trial Results in HIV-1 Infected Subjects with Renal Impairment
14.5 Clinical Trial Results in HIV-1 Treatment-Naïve Adolescent Subjects Aged 12 to Less than 18
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 kg who have no 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 for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of GENVOYA [see CLINICAL STUDIES (14)].
2 DOSAGE AND ADMINISTRATION
2.1 Testing Prior to Initiation and During Treatment with GENVOYA
Prior to initiation of GENVOYA, patients should be tested for hepatitis B virus infection [see WARNINGS AND PRECAUTIONS (5.1)].
It is recommended that serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose and urine protein be assessed before initiating GENVOYA and during therapy in all patients as clinically appropriate [see WARNINGS AND PRECAUTIONS (5.4)].
2.2 Recommended Dosage
GENVOYA is a four-drug fixed dose combination product containing 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide (TAF). The recommended dosage of GENVOYA is one tablet taken orally once daily with food in adults and pediatric patients 12 years of age and older with body weight at least 35 kg and creatinine clearance greater than or equal to 30 mL per minute [see USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)].
2.3 Not Recommended in Patients with Severe Renal Impairment
GENVOYA is not recommended in patients with estimated creatinine clearance below 30 mL per minute [see USE IN SPECIFIC POPULATIONS (8.6)].
2.4 Not Recommended in Patients with Severe Hepatic Impairment
GENVOYA is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) [see USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].
3 DOSAGE FORMS AND STRENGTHS
Each GENVOYA tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide (TAF) (equivalent to 11.2 mg of tenofovir alafenamide fumarate).
The tablets are green, capsule-shaped, film-coated tablets, debossed with "GSI" on one side of the tablet and the number "510" on the other side of the tablet.
4 CONTRAINDICATIONS
Coadministration of GENVOYA is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threate |
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