Tenofovir disoproxil fumarate is an antiviral drug

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. VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.

• 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.
• 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. Oral powder: 8 mg/kg VIREAD oral powder (up to a maximum of 300 mg) once daily with food.
• Dose recommended in renal impairment in adults: Creatinine clearance 30-49 mL/min: 300 mg every 48 hours. Creatinine clearance 10-29 mL/min: 300 mg every 72 to 96 hours. Hemodialysis: 300 mg every 7 days or after approximately 12 hours of dialysis.

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. In HBV-infected subjects with compensated liver disease: most common adverse reaction (all grades) was nausea (9%). In pediatric subjects: Adverse reactions in pediatric subjects were consistent with those observed in adults. 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.

None.

• 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.
• 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.
• HIV testing: HIV antibody testing should be offered to all HBVinfected 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.
• 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. See package insert for complete information.