Pemafibrate

EACH LUCIPEMAFIB TABLET CONTAINS: Pemafibrate …………… 0.1 mg

INDICATION

LuciPemafib is indicated for the treatment of hyperlipidemia (including familial hyperlipidemia) in patients with elevated triglycerides.

It is used to reduce serum triglycerides, very low-density lipoprotein (VLDL) cholesterol, and low-density lipoprotein (LDL) cholesterol, and to improve lipid abnormalities in patients with dyslipidemia.

It is indicated in patients who do not achieve adequate lipid control with diet and lifestyle modification alone.

DOSAGE AND ADMINISTRATION

Recommended Dosage:

The recommended dose is 0.2 mg daily, administered as 0.1 mg twice daily (morning and evening), with or without food.

• Dose adjustment may be required in patients with renal impairment.
• The dose may be increased up to a maximum of 0.4 mg per day (0.2 mg twice daily) based on clinical response and tolerability.

DOSAGE FORM AND STRENGTH

Tablets: 0.1 mg, film-coated tablets, engraved with “LUCIUS” on one side and plain on the other side.

STORAGE

Store below 30°C (86°F) in a dry place.

Protect from moisture.

Keep out of reach of children.

WARNINGS AND PRECAUTIONS

• To be used under the supervision of a registered medical practitioner.
• Monitor liver function and renal function periodically during treatment.
• Use with caution in patients with hepatic impairment.
• Risk of rhabdomyolysis, particularly when used concomitantly with statins.
• Use caution in patients with renal impairment; dose adjustment may be required.

CONTRAINDICATIONS

• Severe hepatic impairment
• Severe renal impairment (unless appropriately monitored)
• Known hypersensitivity to pemafibrate or any component of the formulation

MANUFACTURED AND MARKETED BY

LUCIUS PHARMACEUTICALS (LAO) CO., LTD

No. 26, Thongmang Village, Xaythany District, Vientiane Capital, Laos