(tenofovir alafenamide) Tablets
POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B
Discontinuation of anti-hepatitis B therapy, including HEPBEST, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including HEPBEST. If appropriate, resumption of anti-hepatitis B therapy may be warranted
HEPBEST is a tablet containing tenofovir alafenamide for oral administration. Tenofovir alafenamide, a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate.
Each tablet contains 25 mg of tenofovir alafenamide (equivalent to 28 mg of tenofovir alafenamide fumarate). The tablets include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets are film coated with a coating material containing: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
The chemical name of tenofovir alafenamide fumarate drug substance is L-alanine, N– [(S)-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]phenoxyphosphinyl]-, 1- methylethyl ester, (2E)-2-butenedioate (2:1).
It has an empirical formula of C21H29O5N6P•½(C4H4O4) and a formula weight of 534.50.
It has the following structural formula:
Tenofovir alafenamide fumarate is a white to off-white or tan powder with a solubility of 4.7 mg per mL in water at 20 °C.
HEPBEST is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease
Recommended Dosage In Adults
The recommended dosage of HEPBEST is 25 mg (one tablet) taken orally once daily with food
Dosage In Patients With Renal Impairment
No dosage adjustment of HEPBEST is required in patients with mild, moderate, or severe renal impairment. HEPBEST is not recommended in patients with end stage renal disease (estimated creatinine clearance below 15 mL per minute)
Dosage In Patients With Hepatic Impairment
No dosage adjustment of HEPBEST is required in patients with mild hepatic impairment (Child-Pugh A). HEPBEST is not recommended in patients with decompensated (Child- Pugh B or C) hepatic impairment
Dosage Forms And Strengths
Tablets: 25 mg of tenofovir alafenamide (equivalent to 28 mg of tenofovir alafenamide fumarate) — yellow, round, film-coated tablets, debossed with “GSI” on one side of the tablet and “25” on the other side.
Storage And Handling
HEPBEST tablets containing 25 mg of tenofovir alafenamide are yellow, round, film-coated, debossed with “GSI” on one side and “25” on the other side. Each bottle contains 30 tablets (NDC61958-2301-1), a silica gel desiccant, polyester coil, and is closed with a child-resistant closure.
Store below 30 °C (86 °F).
- Keep container tightly closed.
- Dispense only in original container.