Pemafate

Pemafate is indicated for:

Approved Indications:

• Treatment of hypertriglyceridemia and mixed dyslipidemia in adults as an adjunct to diet and lifestyle modification.
• Used to reduce elevated triglycerides and increase HDL cholesterol levels.

Off-Label / Clinically Accepted Uses:

• Add-on therapy for patients on statins with residual hypertriglyceridemia.
• Management of metabolic dyslipidemia, type 2 diabetes-associated dyslipidemia, and non-alcoholic fatty liver disease (NAFLD).

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

• Adults: 0.1 mg twice daily or 0.2 mg once daily.
• Maximum dose: 0.4 mg once daily if needed.
• Renal impairment: Use with caution; avoid in severe impairment.
• Hepatic impairment: Contraindicated in moderate to severe hepatic dysfunction.
• Elderly: Start at the lowest effective dose; monitor function.
• Pediatric: Safety not established.
• Administration: Take orally with or after meals.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Pemafibrate is a Selective Peroxisome Proliferator-Activated Receptor Alpha Modulator (SPPARM-α).
It activates hepatic PPAR-α receptors, promoting fatty acid oxidation, reducing VLDL synthesis, lowering triglycerides, and raising HDL-C, thereby improving overall lipid metabolism.

• Absorption: Rapid after oral administration.
• Distribution: Highly protein-bound (>99%).
• Metabolism: Extensively metabolized in the liver (mainly via CYP3A4).
• Excretion: Mainly through bile/feces; minimal renal clearance.
• Half-life: ~20 hours.

• Pregnancy: Category C – use only if clearly needed; potential fetal risk based on animal data.
• Lactation: Unknown if excreted in breast milk; avoid during breastfeeding or discontinue nursing.

Lipid-regulating agent / Selective PPAR-α Modulator (SPPARM-α)

• Severe hepatic impairment
• Active gallbladder disease
• Known hypersensitivity to Pemafibrate or other fibrates
• Nursing mothers

• Monitor liver enzymes (ALT, AST) periodically.
• Risk of myopathy or rhabdomyolysis, especially when used with statins.
• Discontinue if unexplained muscle pain or abnormal liver tests occur.
• Use caution in patients with renal impairment, gallstones, or hypothyroidism.

Common: Abdominal discomfort, constipation, elevated liver enzymes, headache.
Serious / Rare: Myopathy, rhabdomyolysis, gallstones, pancreatitis, hypersensitivity reactions.

• Statins: Increased risk of myopathy; monitor.
• Warfarin: May enhance anticoagulant effect; monitor INR.
• Cyclosporine: Contraindicated – increases Pemafibrate exposure.
• Rifampicin: Decreases Pemafibrate level; avoid co-administration.
• Bile acid sequestrants: Reduce absorption; take separately.

• Recent studies (PROMINENT Trial) confirm Pemafibrate effectively lowers triglycerides and is safer for kidneys and liver than traditional fibrates.
• Approved and widely used in Japan for hyperlipidemia (0.2 mg daily dose).

• Store below 30 °C, in a dry place away from light and moisture.
• Keep out of reach of children.