Pemafate(Pemafibrate)
Therapeutic Group: Hypertriglyceridemia
Presentation
Pemafate Tablet: Each film coated tablet contains pemafibrate INN 0.1 mg
Description
Pemafibrate binds to PPAR? with high selectivity and potency. Binding to PPAR? regulates the target gene expression, leading to decreased plasma triglyceride (TG) concentration, decreased triglyceride-rich lipoprotein,decreased apolipoprotein (Apo) C-3 and increased HDL-cholesterol. Pemafibrate may modulate inflammation and oxidative stress by inhibiting the expression of pro-inflammatory cytokines and adhesion molecules. This anti-inflammatory action can further contribute to cardiovascular protection by reducing the inflammatory component of atherosclerosis, a condition characterized by the buildup of fatty deposits in the arterial walls.
Indications
Pemafibrate is indicated as adjunctive therapy to diet to reduce TG in patients with dyslipidemia, including familial hyperlipidemia.
Dosage & Administration
Adult dose: The usual adult dosage is 0.1 mg of pemafibrate orally administered twice daily. The dose may be individualized according to the patient’s age and symtoms. Pemafibrate can be taken with or without food.
Use in children: The safety of Pemafibrate in children has not been established.
Renal impairment: Pemafibrate should be used with caution in patients with renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mg/min/1.73 m2 .A lower starting dose or prolong dosing intervals should be considered. The maximum dose is 0.2 mg daily.
Hepatic impairment: Pemafibrate should be used with caution in patients with severe hepatic disorder
Precautions
An increased risk of rhabdomyolysis has been reported with other fibrates when co-administered with an HMG-CoA reductase inhibitor (statin), especially in case of pre-existing muscular disease. Pemafibrate should be used with caution in patients receiving statins. Muscle toxicity should be suspected in patients presenting diffuse myalgia, myositis, muscle cramps and weakness and/or marked increase in (CK>5 times the upper limit of normal range [ULN]). In such cases, treatment with Pemafibrate should be stopped. Pemafibrate should be used with caution in patients with hepatic disorder or those with history of hepatic disorder. Abnormal liver function tests may occur. The plasma concentration of Pemafibrate may increase in patients with hepatic disorder (Child-Pugh grade A cirrhosis, etc). Liver function should be monitored periodically during treatment. Since cholelithiasis has been reported, Pemafibrate should be used with caution in patients with a history of cholelithiasis. Since increase in LDL-cholesterol levels may occur, LDL-cholesterol levels should be monitored periodically during treatment
Commercial Pack
Pemafate Tablet: Each box contains 5 Alu Alu blister strips of 10 tablets.