tenofovir alafenamide


Mylan Healthcare


Antah Pharma
Concise Prescribing Info
Tenofovir alafenamide
Chronic hepatitis B in adults & adolescents ≥12 yr weighing at least 35 kg.
Dosage/Direction for Use
Should be taken with food.
Special Precautions
Does not prevent risk of HBV transmission. Nephrotoxicity. HBV & hepatitis C or D virus co-infection; hepatitis B & HIV co-infection. Increased risk of hepatic decompensation following hepatitis exacerbation in patients w/ cirrhosis. Monitor hepatobiliary & renal parameters in HBV-infected patients w/ decompensated liver disease & Child-Pugh-Turcotte score >9 (class C); hepatic function at repeated intervals during & for at least 6 mth after last dose. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not be co-administered w/ tenofovir alafenamide-, tenofovir disoproxil fumarate- or adefovir dipivoxil-containing products. Not recommended w/ certain anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarb, phenytoin), antimycobacterials (eg, rifampicin, rifabutin, rifapentine) or St. John's wort; strong P-gp inhibitors eg, itraconazole, ketoconazole. May affect ability to drive & use machines. Not recommended in patients w/ CrCl <15 mL/min not receiving dialysis. Pregnancy. Not to be used during lactation. Childn <12 yr, <35 kg.
Adverse Reactions
Headache. Diarrhoea, vomiting, nausea, abdominal pain & distension, flatulence; fatigue; dizziness; rash, pruritus; increased ALT; arthralgia.
Drug Interactions
Decreased plasma conc w/ P-gp inducers eg, rifampicin, rifabutin, carbamazepine, phenobarb or St. John's wort. Increased plasma conc w/ P-gp or BCRP inhibitors. Decreased Cmax w/ carbamazepine, oxcarbazepine, phenobarb, phenytoin, rifampicin, rifapentine, rifabutin, tipranavir/ritonavir, efavirenz, St. John's wort (Hypericum perforatum). Increased Cmax w/ itraconazole, ketoconazole, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, atazanavir/cobicistat, atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir, dolutegravir.
MIMS Class
ATC Classification
J05AF13 - tenofovir alafenamide ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
MyTAFF FC tab 25 mg
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