RECENT MAJOR CHANGES

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 12 years of age and older. (1)

VIREAD is indicated for the treatment of chronic hepatitis B in adults. (1)

DOSAGE AND ADMINISTRATION

• Recommended dose for the treatment of HIV-1 or chronic hepatitis B in adults: 300 mg once daily taken orally without regard to food. (2.1)
• Recommended dose for the treatment of HIV-1 in pediatric patients (12 years of age and older and weighing greater than or equal to 35 kg): 300 mg once daily taken orally without regard to food. (2.2)
• 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: 300 mg. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

• New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Assess creatinine clearance (CrCl) before initiating treatment with VIREAD. Monitor CrCl and serum phosphorus in patients at risk. Avoid administering VIREAD with concurrent or recent use of nephrotoxic drugs. (5.3)
• Coadministration with Other Products: Do not use with other tenofovir-containing products (e.g., ATRIPLA, COMPLERA, and TRUVADA). Do not administer in combination with HEPSERA. (5.4)
• 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)
• Decreases in bone mineral density (BMD): Observed in HIV-infected patients. Consider assessment of BMD in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss. (5.6)
• Redistribution/accumulation of body fat: Observed in HIV-infected patients receiving antiretroviral combination therapy. (5.7)
• Immune reconstitution syndrome: Observed in HIV-infected patients. May necessitate further eva luation and treatment. (5.8)
• 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 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)

In HBV-infected subjects with compensated liver disease: most common adverse reaction (all grades) was nausea (9%). (6)

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)

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

DRUG INTERACTIONS

• 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)
• Atazanavir: Coadministration decreases atazanavir concentrations and increases tenofovir concentrations. Use atazanavir with VIREAD only with additional ritonavir; monitor for evidence of tenofovir toxicity. (7.2)
• Lopinavir/ritonavir: Coadministration increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity. (7.3)

USE IN SPECIFIC POPULATIONS

• Pregnancy: There is a pregnancy registry available.
• Nursing mothers: Women infected with HIV should be instructed not to breast feed. (8.3)
• Safety and efficacy not established in patients less than 12 years of age. (8.4)