Alenvir is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.
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.
The following adverse reactions are discussed in other sections of the labeling:
Pregnancy: Based on prospective reports to the APR of over 660 exposures to TAF-containing regimens during pregnancy resulting in live births (including over 520 exposed in the first trimester and over 130 exposed in the second/third trimester), the prevalence of birth defects in live births was 4.2% (95% CI: 2.6% to 6.3%) and 3.0% (95% CI: 0.8% to 7.5%) following first and second/third trimester exposure, respectively, to TAF-containing regimens. Methodologic limitations of the APR include the use of MACDP as the external comparator group.
If overdose occurs, monitor patient for evidence of toxicity. Treatment of overdosage with Alenvir consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Alenvir is efficiently removed by hemo- dialysis with an extraction coefficient of approximately 54%.
Hepatic viral infections (Hepatitis B)
Store below 30°C. Keep it in its original container. protect from light. Keep out of children’s reach.