Pemafate Tablet
Pemafibrate
0.1 mg
Incepta Pharmaceuticals Ltd.
| Pack size | 50's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 10.00 AED |
Indications
Pemafate Tablet is used for:
Hypertriglyceridemia, dyslipidemia, familial hyperlipidemia
Adult Dose
Adult
Oral
Pemafibrate is indicated as adjunctive therapy to diet to reduce TG in patients with dyslipidemia, including familial hyperlipidemia
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 symptoms.
Child Dose
Renal Dose
Renal Impairment
In patients with renal impairment, renal function should be monitored periodically during treatment with Pemafibrate.
If eGFR is <30 mL/min/1.73 m2, dose reduction or prolonged dosing intervals should be considered.
The maximum dose is 0.2 mg daily.
Administration
Can be taken with or without food.
Contra Indications
Pemafibrate is contraindicated in
patients with known hypersensitivity to Pemafibrate or to any of the excipients.
patients with severe hepatic disorder, Child-Pugh grade B or C cirrhosis, or biliary obstruction
patients with cholelithiasis
pregnant or possibly pregnant women
patients receiving concomitant cyclosporine or rifampicin
Precautions
An increased risk of rhabdomyolysis has been reported with other fibrates when co-administered with an HMG-CoA reductase inhibitor (statin), especially in cases 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 disorders or those with a history of hepatic disorders. 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.
Monitoring Parameters
Before starting therapy (baseline):
Lipid profile (TG, HDL-C, LDL-C, non-HDL-C, ApoB, ApoC-III).
Liver function tests (ALT, AST, ALP, total bilirubin).
Renal function (serum creatinine, eGFR, BUN).
CK (creatine kinase) if history of myopathy or on statin.
HbA1c / fasting glucose (esp. in type 2 diabetes).
CBC (if patient has risk of cytopenias).
During therapy (follow-up):
Lipid profile 4–8 weeks after initiation, then periodically.
Liver function tests at 3 months, then every 6–12 months.
Renal function (eGFR, creatinine): at 3 months, then every 6–12 months.
CK (creatine kinase): if muscle pain, weakness, or statin combination therapy.
HbA1c / fasting glucose: periodically in diabetics.
Uric acid: if history of gout/hyperuricemia (pemafibrate may reduce uric acid).
Special precautions:
Stop the drug if ALT/AST >3× ULN persistently, or eGFR falls <30 mL/min/1.73m².
Avoid in severe hepatic impairment or ESRD/dialysis.
Pregnancy-Lactation
Pregnancy:
Pemafibrate is contraindicated in pregnant or possibly pregnant women. The safety of Pemafibrate has not been established for use during pregnancy.
Breastfeeding:
The use of Pemafibrate should be avoided in breastfeeding women. If the administration of Pemafibrate is unavoidable, Breastfeeding should be discontinued.
Interactions
Major interactions
Statins (atorvastatin, rosuvastatin, simvastatin, pravastatin):
Increased risk of myopathy/rhabdomyolysis. Use the lowest effective statin dose; monitor CK and muscle symptoms.
Other fibrates (fenofibrate, bezafibrate, gemfibrozil):
Not recommended – no added benefit, ↑ risk of hepatic/renal/muscle toxicity.
Cyclosporine, tacrolimus:
May alter pemafibrate metabolism; ↑ risk of nephrotoxicity. Monitor renal function closely.
Warfarin (and other vitamin K antagonists):
Pemafibrate may enhance the anticoagulant effect. Monitor INR/PT frequently; adjust dose.
Adverse Effects
Side effects of Pemafibrate :
>1%
Cholelithiasis
Diabetes Mellitus
>0.1 to < 1%
Hepatic function abnormality
Increase aspartate aminotransferase
Increase alanine aminotransferase
Increase blood creatine phosphokinase
Increase blood myoglobin
Myalgia
Rash
Itching
Increase glycosylated hemoglobin
Increase low-density lipoprotein
Increase blood uric acid
Unknown incidence
Hepatic function disorders
Jaundice
Mechanism of Action
Pemafibrate binds to PPARα with high selectivity and potency. Binding to PPARα 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.
Note
Pemafate 0.1 mg Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Pemafibrate. Pemafate is availble in Bangladesh.
Farmaco BD drug index information on Pemafate Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.