Tafnat

Tafnat

tenofovir alafenamide

Manufacturer:

Natco Pharma

Distributor:

Atlanta Medicare

Marketer:

Atlanta Medicare
Concise Prescribing Info
Contents
Tenofovir alafenamide
Indications/Uses
Chronic hepatitis B in adults & adolescents ≥12 yr weighing 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
Risk of transmission of HBV. Closely monitor hepatobiliary & renal parameters in patients w/ decompensated liver disease & Child Pugh Turcotte score >9, cirrhosis. Monitor hepatic function at repeated intervals w/ follow-up for at least 6 mth after discontinuation of treatment. Advanced liver disease or cirrhosis. Patients w/ renal impairment (CrCl <15 mL/min) not receiving haemodialysis, co-infected w/ hepatitis C or D virus. Potential risk of nephrotoxicity. HIV Ab testing should be offered to all HBV-infected patients whose HIV-1 infection status is unknown before initiation of therapy. Concomitant use w/ products containing tenofovir alafenamide, tenofovir disoproxil fumarate or adefovir dipivoxil; certain anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarb & phenytoin), antimycobacterials (eg, rifampicin, rifabutin & rifapentine) or St. John's wort; strong P-gp inhibitors (eg, itraconazole & ketoconazole). Galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. Pregnancy & lactation.
Adverse Reactions
Headache. Diarrhoea, vomiting, nausea, abdominal pain & distension, flatulence; fatigue; dizziness; rash, pruritus; increased ALT; arthralgia.
Drug Interactions
Decreased effects w/ anticonvulsants eg, carbamazepine, oxcarbazepine, phenobarb, phenytoin; antimycobacterials eg, rifampicin, rifapentine & rifabutin; tipranavir/ritonavir; St. John's wort (Hypericum perforatum). Increased effects w/ itraconazole & ketoconazole. Increased AUC & Cmax w/ PIs eg, atazanavir/cobicistat, atazanavir/ritonavir, darunavir/cobicistat, darunavir/ritonavir, lopinavir/ritonavir.
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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