Tenofovir

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Tenofovir
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: Vignesh Ponnusamy, M.B.B.S. [2]

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Black Box Warning

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS
See full prescribing information for complete Boxed Warning.
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD.
  • Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including VIREAD. Hepatic function should be monitored closely in these patients. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

Overview

Tenofovir is a HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor that is FDA approved for the {{{indicationType}}} of HIV-1 infection in adults and pediatric patients 2 years of age and older, chronic hepatitis B in adults and pediatric patients 12 years of age and older. There is a Black Box Warning for this drug as shown here. Common adverse reactions include rash, diarrhea, headache, pain, depression, asthenia, and nausea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

HIV-1 Infection
  • Dosing Information
  • The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food.
Chronic Hepatitis B
  • Dosing Information
  • The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

HIV infection - Type B viral hepatitis, chronic
  • Developed by: The Department of Health and Human Services Panel on Antiretroviral Guidelines and the American Association for the Study of Liver Diseases (AASLD)
  • Class of Recommendation: Adult, Class IIa
  • Strength of Evidence: Adult, Category B
  • Dosing Information
  • Tenofovir 300 mg/day[1]

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tenofovir in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

HIV-1 Infection
  • Pediatric Patients 12 Years of Age and Older (35 kg or more)
  • The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food.
  • For the treatment of HIV-1 in pediatric patients 2 years of age and older, the recommended oral dose of VIREAD is 8 mg of tenofovir disoproxil fumarate per kilogram of body weight (up to a maximum of 300 mg) once daily administered as oral powder or tablets.
  • VIREAD oral powder should be measured only with the supplied dosing scoop. One level scoop delivers 1 g of powder which contains 40 mg of tenofovir disoproxil fumarate. VIREAD oral powder should be mixed in a container with 2 to 4 ounces of soft food not requiring chewing (e.g., applesauce, baby food, yogurt). The entire mixture should be ingested immediately to avoid a bitter taste. Do not administer VIREAD oral powder in a liquid as the powder may float on top of the liquid even after stirring. Further patient instructions on how to administer VIREAD oral powder with the supplied dosing scoop are provided in the FDA-approved patient labeling (Patient Information).
  • VIREAD is also available as tablets in 150, 200, 250 and 300 mg strengths for pediatric patients who weigh greater than or equal to 17 kg and who are able to reliably swallow intact tablets. The dose is one tablet once daily taken orally, without regard to food.
  • Tables 1 and 2 contain dosing recommendations for VIREAD oral powder and tablets based on body weight. Weight should be monitored periodically and the VIREAD dose adjusted accordingly.



Chronic Hepatitis B
  • Pediatric Patients 12 Years of Age and Older (35 kg or more)
  • The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tenofovir in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tenofovir in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS
See full prescribing information for complete Boxed Warning.
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD.
  • Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including VIREAD. Hepatic function should be monitored closely in these patients. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Tenofovir in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Tenofovir in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tenofovir in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Tenofovir during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Tenofovir with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Tenofovir with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Tenofovir with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Tenofovir with respect to specific gender populations.

Race

There is no FDA guidance on the use of Tenofovir with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Tenofovir in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Tenofovir in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Tenofovir in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Tenofovir in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Tenofovir in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Tenofovir in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Tenofovir in the drug label.

Pharmacology

There is limited information regarding Tenofovir Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Tenofovir in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Tenofovir in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Tenofovir in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Tenofovir in the drug label.

How Supplied

Storage

There is limited information regarding Tenofovir 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 Patient Counseling Information of Tenofovir in the drug label.

Precautions with Alcohol

  • Alcohol-Tenofovir interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Lacombe K, Gozlan J, Boyd A, Boelle PY, Bonnard P, Molina JM; et al. (2008). "Comparison of the antiviral activity of adefovir and tenofovir on hepatitis B virus in HIV-HBV-coinfected patients". Antivir Ther. 13 (5): 705–13. PMC 2665195. PMID 18771054.
  2. ↑ Empty citation (help)
  3. ↑ "http://www.ismp.org". External link in |title= (help)


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