Tevirax^®

Tevirax is a preparation of Tenofovir Alafenamide which is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor. It as a lipophilic cell-permeant
compound enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATPIBI and OATPIB3. Tenofovir Alafenamide is then converted to Tenofovir through hydrolysis primarily by carboxylesterase I (CESI) in primary hepatocytes. Intracellular tenofovir is subsequently phosphorylated by cellular kinases to the phanmcologically 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.

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Tevirax are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated
liver disease.

Route of administration: Tevirax@ should be administered in oral route with food.

The recommended dosage is one Tevirax@ tablet once daily.
Patients should be periodically reassessed to determine the
need for mamtenance treatment and the appropriate dose for
such treatment.

Pregnancy: There are no well controlled studies ofpregnant women exposed to tenofovir of a dntg-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Lactation: There is no information regarding the presence of tenofovir in human milk, the effects on the breastfed infant or the effects on milk production. The developmental
and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the breastfed infant from the combination
or from the underlying maternal condition.

Use in children and adolescents
Safety and effectiveness of tenofovir has not been established in pediatric patients less than 6 years of age or weigh less than 25 kg.

Discontinuation of anti-hepatitis B therapy, including tenofovir alafenamide, may result in severe acute exacerbations of hepatitis B. Patients who discontinue tenofovir alafenamide should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. Due to the risk of development of HIV-I resistance, tenofovir alafenamide alone is not recommended for the treatment of HIV-I infection. HIV antibody testing should be offered to all HBV infected patients before initiating therapy with tenofovir alafenamide, and, if positive, an appropriate antiretroviral combination regimen that is recommended for patients coinfected with HIV-I should be used. There's a risk of renal impairment, including acute renal failure, proximal renal tubulopathy, lactic acidosis, severe hepatomegaly with steatosis and Fanconi syndrome with TAF containing products and nucleoside analogs. Caution should be taken.

The most common side effects are headache, abdominal pain, cough, back pain, fatigue and nausea.

It is contraindicated in patients with history of known hypersensitivity to tenofovir or any other components of this product.

Drug interaction with medication: Concomitant use of tenofovir with drugs that inhibit P-gp, BCRP and drugs that reduce renal function or compete for active tubular secretion may increase the absorption and plasma concentration of tenofovir and this may Increase the risk of adverse reactions. Dosage adjustments may be required. Concomitant use of
tenofovir alafenamide with oxcarbazepme, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine or St. John's wort is not recommended.

Drug interaction with food and others: Not applicable.

In case of overdose, supportive care with close medical supervision should be initiated. Tenofovir is efficiently removed by hemodialysis.

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Tevirax tablet: Each coated tablet contams Tenofovir Alafenamide 25 mg as Tenofovir Alafenamide Fumarate INN.

Storage
Store below 300C in a dry place, protected from light. Keep away from the reach of children.

Packing
Tevirax tablet: Carton of 10 tablets in blister pack.