Tafnat (Tenofovir Alafenamide) 25 mg Tablets (30 Count)

Tafnat is supplied as round, film-coated bluish-green tablets:

• Packaging: Original high-density polyethylene (HDPE) bottle containing 30 tablets (30-day supply), enclosed in a cardboard box with a patient leaflet.
• Active Ingredient: Tenofovir Alafenamide I.P. — 25 mg per tablet (as fumarate).
• Excipients: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide.
• Film Coating: Opadry II (hypromellose, titanium dioxide, lactose monohydrate, triacetin, colorants).

Pharmacodynamics: Tenofovir Alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI). TAF is a targeted prodrug of tenofovir. Once inside hepatocytes, it is intracellularly converted to tenofovir diphosphate, which inhibits HBV reverse transcriptase, incorporating into viral DNA and causing chain termination, thereby stopping viral replication.

Pharmacokinetics: Following oral administration with food, TAF is rapidly absorbed. Peak plasma concentration occurs within 0.4–0.5 hours. Plasma protein binding is approximately 80%. TAF is metabolized intracellularly by carboxylesterase 1 (CES1). Excretion occurs mainly via feces (31.7%) and renal elimination (<1%). TAF plasma half-life is ~0.51 hours, but its active intracellular metabolite resides substantially longer.

Tafnat is indicated for:

• 🔹 Treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients aged 12 years and older weighing at least 35 kg.
• 🔹 Suitable for patients with compensated liver disease (without cirrhosis or Child-Pugh Class A cirrhosis) and those with elevated risks of renal dysfunction or osteoporosis.
• 🔹 As part of combination ART regimens for HIV-1 infection management (under specialist guidance).

Recommended dosage and administration for Tafnat:

• 💊 Dosage: Take 1 tablet (25 mg) orally once daily.
• 🥤 Administration: Swallow whole with water. Must be taken with food to enhance oral absorption and bioavailability.
• ⏰ Timing: Take consistently at the same time each day. Do not crush or chew.
• ⏱️ Treatment Duration: Determined individually by the attending physician. HBV therapy is typically long-term.
• 🤢 Vomiting Management: If vomiting occurs within 1 hour of taking the dose, take another tablet. If over 1 hour has passed, no additional dose is needed.

Tafnat is contraindicated in:

• ❌ Hypersensitivity to Tenofovir Alafenamide or any tablet excipients.
• ❌ Children under 12 years of age or weighing less than 35 kg.
• ❌ Severe renal impairment (CrCl < 15 mL/min) in patients not on chronic hemodialysis.
• ❌ Patients with lactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption.
• ❌ Co-administration with other tenofovir-containing drugs (e.g., TDF).

Important drug interactions with Tafnat:

• ⚠️ P-glycoprotein (P-gp) Inducers: Co-administration with strong P-gp inducers (rifampin, carbamazepine, oxcarbazepine, phenobarbital, St. John’s wort) significantly decreases TAF plasma concentrations, leading to loss of therapeutic effect.
• ⚠️ HIV Antiretrovirals: Regimens containing boosted protease inhibitors (e.g., atazanavir/darunavir with cobicistat or ritonavir) may increase TAF exposure.
• ⚠️ Nephrotoxic Agents: Avoid concomitant use with high-dose NSAIDs due to potential renal toxicity risks.

Usage considerations during pregnancy and nursing:

• 🤰 Pregnancy: Human data regarding TAF use in pregnant women are limited. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• 🤱 Lactation: It is unknown whether TAF is excreted in human milk. Breastfeeding is not recommended during therapy.

Tafnat has a favorable safety profile. Common adverse events include:

• 🔴 Very Common (≥1/10): Headache.
• 🟡 Common (≥1/100 to <1/10): Dizziness, nausea, diarrhea, abdominal pain, fatigue, arthralgia, rash, pruritus.
• 🟢 Laboratory Events: Transient ALT elevations may occur in the first weeks of treatment.

Clinical experience with acute TAF overdose is limited:

• Symptoms: Exaggeration of common adverse reactions (headache, GI distress) may occur.
• Management: Symptomatic and supportive treatment. Hemodialysis efficiently removes tenofovir (extraction ratio ~54%).

Storage instructions for Tafnat:

• 🌡️ Temperature: Store below 30 °C in the original container.
• ☀️ Protection: Protect from light and moisture. Keep the bottle tightly closed. Do not remove the desiccant canister.
• 👶 Safety: Keep out of reach of children.

Tafnat by Natco Pharma features multi-level authenticity protections:

• 🛡️ Holographic Seal: The opening flap of the outer carton is sealed with a genuine NATCO hologram sticker that shows tamper evidence if opened.
• 🔍 Tamper-Evident Bottle Seal: The turquoise HDPE bottle has a break-ring safety cap and an induction foil seal over the bottle neck.
• 📦 Factory Markings: Clear embossing of Batch No., Manufacturing Date, Expiry Date, License No., and the "For India Only" mark on the packaging.