Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

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Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Allison Tu [2]

Disclaimer

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Black Box Warning

POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
See full prescribing information for complete Boxed Warning.
  • GENVOYA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of GENVOYA have not been established in patients coinfected with human immunodeficiency virus-1 (HIV-1) and HBV.
  • Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of GENVOYA.
  • Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue GENVOYA. If appropriate, anti-hepatitis B therapy may be warranted.

Overview

Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide is a combination of an HIV-1 integrase strand transfer inhibitor, a CYP3A inhibitor, and two HIV-1 nucleoside analog reverse transcriptase inhibitors that is FDA approved 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. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea and decreased bone mineral density.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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.

Dosing Information

  • 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in pediatric patients.

Contraindications

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Contraindications in the drug label.

Warnings

POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
See full prescribing information for complete Boxed Warning.
  • GENVOYA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of GENVOYA have not been established in patients coinfected with human immunodeficiency virus-1 (HIV-1) and HBV.
  • Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of GENVOYA.
  • Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue GENVOYA. If appropriate, anti-hepatitis B therapy may be warranted.

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in geriatric settings.

Gender

There is no FDA guidance on the use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Administration in the drug label.

Monitoring

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide and IV administrations.

Overdosage

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Mechanism of Action in the drug label.

Structure

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Structure in the drug label.

Pharmacodynamics

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Clinical Studies in the drug label.

How Supplied

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide How Supplied in the drug label.

Storage

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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