Tafnat

Tafnat

tenofovir alafenamide

Manufacturer:

Natco Pharma

Distributor:

Integrated Market Services
Concise Prescribing Info
Contents
Tenofovir alafenamide
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 HBV transmission through sexual contact or blood contamination. Monitor hepatobiliary & renal parameters in HBV-infected patients w/ decompensated liver disease & Child-Pugh-Turcotte score >9 (ie, class C). Exacerbation of hepatitis. Closely monitor patients w/ cirrhosis during therapy. Monitor hepatic function at repeated intervals w/ clinical & laboratory follow-up for at least 6 mth after treatment discontinuation. Treatment discontinuation is not recommended in patients w/ advanced liver disease or cirrhosis. Nephrotoxicity. Patients co-infected w/ HBV & hepatitis C or D virus; HBV & HIV. Not to be co-administered w/ products containing tenofovir alafenamide, tenofovir disoproxil fumarate or adefovir dipivoxil. Not recommended in co-administration w/ P-gp inducers [eg, anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarb & phenytoin), antimycobacterials (eg, rifampicin, rifabutin & rifapentine) or St. John's wort] & strong inhibitors (eg, itraconazole & ketoconazole). Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Dizziness during treatment which 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 or <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); oxcarbazepine; phenytoin; rifapentine; tipranavir/ritonavir; efavirenz; St. John's wort. Increased plasma conc w/ P-gp &/or BCRP inhibitors; itraconazole, ketoconazole; ledipasvir/sofosbuvir, sofosbuvir/velpatasvir; atazanavir/cobicistat, atazanavir/ritonavir, darunavir/cobicistat, darunavir/ritonavir, lopinavir/ritonavir; dolutegravir.
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
Tafnat FC tab 25 mg
Packing/Price
30's
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