HepBest

HepBest

tenofovir alafenamide

Manufacturer:

Mylan Labs

Distributor:

Viatris Pharma
Concise Prescribing Info
Contents
Tenofovir alafenamide fumarate
Indications/Uses
Chronic hepatitis B in adults & adolescents (≥12 yr & at least 35 kg).
Dosage/Direction for Use
Adult & adolescent (≥12 yr & at least 35 kg) 1 tab once daily.
Administration
Should be taken with food.
Contraindications
Special Precautions
Does not prevent risk of transmission of HBV to others through sexual contact or contamination w/ blood. Closely monitor hepatobiliary & renal parameters in HBV infected patients w/ decompensated liver disease & Child Pugh Turcotte score >9 (ie, class C). Higher risk for hepatic decompensation following hepatitis exacerbation in patients w/ cirrhosis. Treatment discontinuation is not recommended in patients w/ advanced liver disease or cirrhosis. Nephrotoxicity. Patients coinfected w/ HBV & hepatitis C or D virus. HIV Ab testing to all HBV infected patients whose HIV-1 infection status is unknown before initiating therapy; co-administer w/ other antiretroviral agents in patients who are co-infected w/ HBV & HIV. Monitor hepatic function at repeated intervals w/ both clinical & lab follow-up for at least 6 mth after discontinuation of treatment for hepatitis B. Not to be co-administered w/ medicinal products containing tenofovir alafenamide, tenofovir disoproxil or adefovir dipivoxil. Not recommended w/ co-administration of P-gp inducers eg, anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarb & phenytoin), antimycobacterials (eg, rifampicin, rifabutin & rifapentine), & St John's wort; strong P-gp inhibitors eg, itraconazole & ketoconazole. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not recommended in patients w/ CrCl <15 mL/min who are not receiving haemodialysis. Do not use during lactation. Childn <12 yr or weighing <35 kg.
Adverse Reactions
Headache. Dizziness; diarrhoea, vomiting, nausea, abdominal pain/distension, flatulence; increased ALT; rash, pruritus; arthralgia; fatigue.
Drug Interactions
May decrease plasma conc w/ P-gp inducers eg, anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarb & phenytoin), antimycobacterials (eg, rifampicin, rifabutin & rifapentine), & St John's wort. May increase plasma conc w/ strong P-gp inhibitors eg, itraconazole & ketoconazole.
MIMS Class
Antivirals
ATC Classification
J05AF13 - tenofovir alafenamide ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
HepBest FC tab 25 mg
Packing/Price
30's
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