Tenofovir disoproxil fumarate.
Each film-coated tablet contains tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg.
Pharmacology: Tenofovir disoproxil fumarate is an acyclic nucleoside phosphonate diester analog of adenosine monophosphate. After phosphorylation to the active tenofovir diphosphate form, it inhibits the activity of human immunodeficiency virus type 1 (HIV-1) reverse transcriptase and hepatitis B virus (HBV) reverse transcriptase by competing with the natural substrate deoxyadenosine 5'-triphosphate and terminates the deoxyribonucleic acid (DNA) chain after incorporation into viral DNA.
Chronic hepatitis B virus infection in adults >18 years. It is also indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Adults ≥18 Years: Chronic Hepatitis B Infection: Recommended Dose: 300 mg once daily with or without food. However, it is generally recommended to be taken with a meal to improve bioavailability.
HIV Infection: Usual Dose: 300 mg once daily.
Renal Impairment: No dose adjustment is necessary for patients with mild renal impairment [creatinine clearance (CrCl) 50-80 mL/min]. Since tenofovir is principally eliminated by the kidney, in the case of severe renal impairment, including cases of acute renal failure and Fanconi syndrome; dosage adjustment is required in all patients with CrCl <50 mL/min, as detailed in the following table. (See table.)
Click on icon to see table/diagram/image
Hepatic Impairment: No dose adjustment is required in patients with hepatic impairment.
Usually none. However, tenofovir is contraindicated to the patients who have hypersensitivity to any of the components of Tenvira.
Co-Administration with Other Drugs: Tenofovir should not be administered concurrently with emtricitabine and 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 exacerbations of hepatitis. Monitor liver function tests every 3 months, and viral and serological markers of hepatitis B every 3-6 months. Discontinue if deterioration in liver function, hepatic steatosis, progressive hepatomegaly or unexplained lactic acidosis. Recurrent hepatitis may occur on discontinuation.
Use in pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Tenofovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are receiving tenofovir.
Use in children: The use of tenofovir is not recommended for pediatric patients.
Use in the elderly: In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Use in pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Tenofovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are receiving tenofovir.
The most common side effects are nausea, vomiting, diarrhoea, unusual stomach discomfort and fatigue.
Co-administration of tenofovir with antiretroviral, entecavir, lamivudine, methadone, oral contraceptives, ribavirin and tacrolimus did not result in significant drug interactions. However, since tenofovir is predominantly eliminated by the kidney, co-administration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either drug.
Store in a cool and dry place. Protect from light.
J05AF07 - tenofovir disoproxil ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
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