Emtricitabine and tenofovir alafenamide fumarate

Emtricitabine and tenofovir alafenamide fumarate
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: AKT

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Black Box Warning

TITLE POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete Boxed Warning. Condition Name: DESCOVY is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of DESCOVY 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 (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of DESCOVY. 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 DESCOVY. If appropriate, initiation of anti-hepatitis B therapy may be warranted

Overview

Emtricitabine and tenofovir alafenamide fumarate is a nucleoside analog reverse transcriptase inhibitors that is FDA approved for the treatment of HIV-1 infection. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

DESCOVY is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

Limitations of Use:

DESCOVY is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. DESCOVY is a two-drug fixed dose combination product containing 200 mg of emtricitabine (FTC) and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of DESCOVY is one tablet taken orally once daily with or without 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)]. For specific dosing recommendations for coadministered third agents, refer to their respective prescribing information

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Emtricitabine and tenofovir alafenamide fumarate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Emtricitabine and tenofovir alafenamide fumarate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

DESCOVY is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

Limitations of Use:

DESCOVY is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. DESCOVY is a two-drug fixed dose combination product containing 200 mg of emtricitabine (FTC) and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of DESCOVY is one tablet taken orally once daily with or without 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)].

For specific dosing recommendations for coadministered third agents, refer to their respective prescribing information

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Emtricitabine and tenofovir alafenamide fumarate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Emtricitabine and tenofovir alafenamide fumarate in pediatric patients.

Contraindications

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Contraindications in the drug label.

Warnings

TITLE POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete Boxed Warning. Condition Name: DESCOVY is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of DESCOVY 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 (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of DESCOVY. 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 DESCOVY. If appropriate, initiation of anti-hepatitis B therapy may be warranted

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Emtricitabine and tenofovir alafenamide fumarate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Emtricitabine and tenofovir alafenamide fumarate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Emtricitabine and tenofovir alafenamide fumarate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Emtricitabine and tenofovir alafenamide fumarate in geriatric settings.

Gender

There is no FDA guidance on the use of Emtricitabine and tenofovir alafenamide fumarate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Emtricitabine and tenofovir alafenamide fumarate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Emtricitabine and tenofovir alafenamide fumarate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Emtricitabine and tenofovir alafenamide fumarate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Emtricitabine and tenofovir alafenamide fumarate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Emtricitabine and tenofovir alafenamide fumarate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Administration in the drug label.

Monitoring

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Emtricitabine and tenofovir alafenamide fumarate and IV administrations.

Overdosage

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate 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 Emtricitabine and tenofovir alafenamide fumarate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Mechanism of Action in the drug label.

Structure

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate How Supplied in the drug label.

Storage

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate 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 Emtricitabine and tenofovir alafenamide fumarate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Emtricitabine and tenofovir alafenamide fumarate 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 Emtricitabine and tenofovir alafenamide fumarate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Emtricitabine and tenofovir alafenamide fumarate 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.