BECOVIR

TENOFOVIR DISOPROXIL FUMARATE

This is indicated for the treatment of: Chronic hepatitis B virus infection in adults HIV infected adults in combination with other anti retroviral agents

Drugs for HIV / Anti-retroviral drugs, Hepatic viral infections (Hepatitis B)

Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analog). Tenofovir alafenamide as a lipophilic cell-permeant compound enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3. Tenofovir alafenamide is then converted to tenofovir through hydrolysis primarily by carboxylesterase 1 (CES1) in primary hepatocytes. Intracellular tenofovir is subsequently phosphorylated by cellular kinases to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain-termination. Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases that include mitochondrial DNA polymerase 8 and there is no evidence of toxicity to mitochondria in cell culture.

The recommended dose of Tenofovir in chronic hepatitis B virus infection in adults 18 years of age and older with adequate renal function is 300 mg once daily with or without food.

Co-administration of Tenofovir with anti-retroviral, entecavir, lamivudine, methadone, oral contraceptives, ribavirin and tacrolimus did not result in significant drug interactions. The effects of co-administration of Tenofovir with other drugs that are renally eliminated or are known to affect renal function have not been evaluated.

Tenofovir is contraindicated in patients with known hypersensitivity to Tenofovir or any component of the product.

The most common side effects are nausea, vomiting, diarrhea and flatulence.

Pregnancy: Pregnancy category B. It should be used during pregnancy only if clearly needed. Lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breast feed if they are taking Tenofovir.

There is no experience of Tenofovir overdose reported in patients

Co-administration with other drugs: Tenofovir should not be administered concurrently with Emtricitabine & Tenofovir combination or Adefovir Dipivoxil. Lactic Acidosis & Severe Hepatomegaly with Steatosis: Though the risk of occurrence of lactic acidosis is low for Tenofovir, treatment should be suspended in any patient who develops lactic acidosis or hepatotoxicity. Exacerbation of hepatitis after discontinuation of treatment: Discontinuation of Tenofovir therapy may be associated with severe acute exacerbation of hepatitis.

Store in a cool and dry place, protected from light and moisture. Keep the medicine out of the reach of children.