TafovirTM is indicated for the treatment of-
- Chronic hepatitis B virus infection in adults.
- HIV infected adults over the age of 18 years, in combination with other antiretroviral agents.
Dosage & Administration
Adults: The recommended dose of TafovirTM is one tablet (containing 300 mg tenofovir disoproxil fumarate), taken orally, once daily with or without food. Children: The safety and efficacy of tenofovir disoproxil fumarate have not been established in patients under the age of 18 years. Consequently, TafovirTM should not be administered to children or adolescents.
General: Patients receiving TafovirTM or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases. Lactic Acidosis/Severe Hepatomegaly with Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of antiretroviral nucleoside analogues alone or in combination, in the treatment of HIV infection. Renal impairment: Tenofovir is principally eliminated by the kidney. Dosing interval adjustment of Tafovir is required in all patients with creatinine clearance <50 mL/min. Renal function should be closely monitored in these patients. Patients at risk for, or with a history of, renal dysfunction should be routinely monitored for changes in serum creatinine and phosphorus. Use in pregnancy: Pregnancy category- B3. No clinical data are available for pregnant women being treated with tenofovir disoproxil fumarate . Use in lactation: It is not known whether tenofovir is excreted in human milk. Mothers should be instructed not to breast feed if they are receiving TafovirTM. Use in children: Safety and effectiveness in pediatric patients have not been established.