Description:

Tenofovir Alafenamide Tablets IP 25mg HepBest (30 tabs) by Mylan (now Viatris) is a generic direct-acting antiviral medication used to treat chronic hepatitis B virus (HBV) infection in adults and adolescents (aged 12 years and older with body weight at least 35 kg) with compensated liver disease. It is a prodrug of tenofovir that delivers the active form more efficiently to liver cells with lower systemic exposure, reducing risks to kidneys and bones compared to older tenofovir formulations. It inhibits HBV replication by interfering with viral DNA synthesis.

Prescription: Prescription-only (Rx). Requires a doctor’s prescription (typically from a hepatologist or infectious disease specialist) with HBV confirmation (e.g., viral load, genotype if needed), liver function tests, and ongoing monitoring. In Ghana, available through pharmacies or specialist clinics following national hepatitis guidelines.

Therapeutic Category:

Antiviral / Nucleotide reverse transcriptase inhibitor / Direct-acting antiviral (DAA) for chronic hepatitis B.

Active Ingredients/Composition:

Each film-coated tablet contains: Tenofovir alafenamide fumarate equivalent to Tenofovir alafenamide 25 mg. Excipients include lactose monohydrate (about 68 mg per tablet in some formulations), and standard tablet components (refer to label for full list).

Vitamins: None.

Minerals: None.

Variant: 25 mg strength tablets (standard adult/adolescent dose; 30-tablet pack for a 1-month supply; film-coated, often white/off-white round biconvex debossed with “M” and “TFI” or similar).

Consume Type:

Oral (tablet; swallow whole with water; take with food to enhance absorption and reduce GI upset).

Directions/Usage: Adults and adolescents ≥12 years and ≥35 kg: One 25 mg tablet once daily, with food. Therapy is initiated and monitored by a specialist. Duration: Often long-term (years) unless seroconversion occurs (e.g., continue 6-12 months after HBeAg seroconversion in non-cirrhotic patients, or longer until HBsAg loss). Do not stop abruptly without medical advice due to risk of HBV flare. Regular monitoring of HBV DNA, ALT, renal function, and bone density recommended. Not for monotherapy in HIV co-infection without full ART regimen.

Common Side Effects:

• Headache
• Nausea, vomiting, abdominal pain
• Fatigue
• Diarrhoea, flatulence
• Cough, back pain, arthralgia
• Rash, pruritus
• Changes in lipids (e.g., increased LDL/triglycerides, decreased HDL) Most are mild; serious rare: Lactic acidosis, severe hepatotoxicity, renal impairment, bone density loss (less than with TDF), HBV flare on discontinuation. Seek immediate help for yellowing skin/eyes, severe fatigue, muscle pain, or breathing issues.

Package Type:

HDPE bottle or blister packs containing 30 film-coated tablets (often in a carton with desiccant; 30’s common for monthly supply).

Storage Advice: Store at room temperature (below 30°C), in the original container to protect from moisture and light. Keep tightly closed and out of reach of children.

Safety Advice:

• Risk of HBV reactivation/flare if stopped abruptly—do not discontinue without specialist guidance; monitor closely post-discontinuation.
• Screen for HIV before starting (not for HIV monotherapy).
• Caution in renal impairment (monitor CrCl; dose adjustment may not be needed but close watch), decompensated liver disease, or co-infection.
• Higher risk of lactic acidosis/hepatotoxicity in females, obese patients, or long-term nucleoside users.
• Avoid in severe hepatic impairment without advice.
• Pregnancy/breastfeeding: Limited data; use if benefits outweigh risks (not recommended during breastfeeding).
• Inform doctor of all medications (e.g., avoid strong CYP3A inducers; caution with nephrotoxic drugs).
• Regular lab tests essential (HBV DNA, LFTs, renal function, lipids, bone markers if at risk).

Product Substitutes: Other tenofovir alafenamide 25 mg generics: Vemlidy (original Gilead), Tafnat, Tenohep AF, or combinations like tenofovir alafenamide + emtricitabine (for HBV/HIV). Alternatives for HBV: Tenofovir disoproxil fumarate (TDF) generics, entecavir, or pegylated interferon—consult specialist per local guidelines (e.g., Ghana National Hepatitis Programme favors DAAs like TAF/TDF).

Manufacturer/Marketer:

Mylan Laboratories Limited (now part of Viatris following merger; originally launched by Mylan).

Country of Origin:

India.