These highlights do not include all the information needed to use VIREAD safely and effectively. See full prescribing information for VIREAD.
VIREAD ® (tenofovir disoproxil fumarate) tablets, for oral use
VIREAD ® (tenofovir disoproxil fumarate) powder, for oral use
Initial U.S. Approval: 2001
WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS
See full prescribing information for complete boxed warning.
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Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD. (5.1)
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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. (5.2)
INDICATIONS AND USAGE
VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor.
VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. (1)
VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. (1)
DOSAGE AND ADMINISTRATION
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Recommended dose for the treatment of HIV-1 or chronic hepatitis B in adults and pediatric patients 12 years of age and older (35 kg or more): 300 mg once daily taken orally without regard to food. (2.1)
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Recommended dose for the treatment of HIV-1 in pediatric patients (2 to less than 12 years of age):
Tablets: for pediatric patients weighing greater than or equal to 17 kg who can swallow an intact tablet, one VIREAD tablet (150, 200, 250 or 300 mg based on body weight) once daily taken orally without regard to food. (2.2)
Oral powder: 8 mg/kg VIREAD oral powder (up to a maximum of 300 mg) once daily with food. (2.2)
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Dose recommended in renal impairment in adults:
Creatinine clearance 30–49 mL/min: 300 mg every 48 hours. (2.3)
Creatinine clearance 10–29 mL/min: 300 mg every 72 to 96 hours. (2.3)
Hemodialysis: 300 mg every 7 days or after approximately 12 hours of dialysis. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 150, 200, 250 and 300 mg (3)
Oral Powder: 40 mg per 1 g of oral powder (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Assess estimated creatinine clearance before initiating treatment with VIREAD. In patients at risk for renal dysfunction, assess estimated creatinine clearance, serum phosphorus, urine glucose and urine protein before initiating treatment with VIREAD and periodically during treatment. Avoid administering VIREAD with concurrent or recent use of nephrotoxic drugs. (5.3)
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Coadministration with Other Products: Do not use with other tenofovir-containing products (e.g., ATRIPLA, COMPLERA, STRIBILD and TRUVADA). Do not administer in combination with HEPSERA. (5.4)
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HIV testing: HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VIREAD. VIREAD should only be used as part of an appropriate antiretroviral combination regimen in HIV-infected patients with or without HBV coinfection. (5.5)
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Decreases in bone mineral density (BMD): Consider assessment of BMD in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss. (5.6)
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Redistribution/accumulation of body fat: Observed in HIV-infected patients receiving antiretroviral combination therapy. (5.7)
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Immune reconstitution syndrome: Observed in HIV-infected patients. May necessitate further eva luation and treatment. (5.8)
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Triple nucleoside-only regimens: Early virologic failure has been reported in HIV-infected patients. Monitor carefully and consider treatment modification. (5.9)
ADVERSE REACTIONS
In HIV-infected adult subjects: Most common adverse reactions (incidence greater than or equal to 10%, Grades 2–4) are rash, diarrhea, headache, pain, depression, asthenia, and nausea. (6.1)
In HBV-infected subjects with compensated liver disease: most common adverse reaction (all grades) was nausea (9%). (6.1)
In pediatric subjects: Adverse reactions in pediatric subjects were consistent with those observed in adults. (6.1)
In HBV-infected subjects with decompensated liver disease: most common adverse reactions (incidence greater than or equal to 10%, all grades) were abdominal pain, nausea, insomnia, pruritus, vomiting, dizziness, and pyrexia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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Didanosine: Coadministration increases didanosine concentrations. Use with caution and monitor for evidence of didanosine toxicity (e.g., pancreatitis, neuropathy). Consider dose reductions or discontinuations of didanosine if warranted. (7.1)
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HIV-1 protease inhibitors: Coadministration decreases atazanavir concentrations and increases tenofovir concentrations. When coadministered with VIREAD, use atazanavir given with ritonavir. Coadministration of VIREAD with atazanavir and ritonavir, darunavir and ritonavir, or lopinavir/ritonavir increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity. (7.2)
USE IN SPECIFIC POPULATIONS
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Nursing mothers: Women infected with HIV should be instructed not to breast feed. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 6/2015
