Source: Health Sciences Authority (SG) Revision Year: 2022 Publisher: Kowa Company, Ltd., 6-29, Nishiki 3-chome, Naka-ku, Nagoya, Aichi, JAPAN
PARMODIA is indicated as adjunctive therapy to diet or other nonpharmacological treatment (e.g. exercise) to reduce TG and to increase HDL-C in patients with dyslipidemia characterised by high TG ≥150 mg/dL, particularly when there is evidence of associated risk such as hypertension and smoking.
Patients should be on a lipid-lowering diet before the initiation of PARMODIA, and should continue dietary control during treatment. Serum lipid levels should be monitored periodically. If an adequate response has not been achieved, complementary or different therapeutic measures should be considered.
The usual adult dose is 0.1 mg twice daily. The dose may be individualized according to the patient’s age and symptoms. The maximum dose is 0.2 mg twice daily.
No dose adjustment is necessary.
Since elderly patients often have reduced physiological function, PARMODIA should be carefully administered with close monitoring for signs of adverse reactions and clinical status of the patient.
The safety of PARMODIA in low birth weight infants, newborns, infants, and children has not been established. No data are available.
PARMODIA should be used with caution in patients with renal impairment defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m². A lower starting dose or prolonged dosing intervals should be considered. The maximum dose is 0.2 mg daily (see section 5.2).
PARMODIA should be used with caution in patients with hepatic disorder (Child-Pugh grade A cirrhosis, etc.) or a history of hepatic disorder. Dose reduction should be considered as necessary (see section 5.2).
PARMODIA is contraindicated in patients with severe hepatic disorder, Child-Pugh grade B or C cirrhosis, or biliary obstruction (see section 4.3 and section 5.2).
PARMODIA should be taken orally twice daily in the morning and evening.
PARMODIA can be taken without regard to meals.
There is no specific treatment in the event of overdose. The patient should be treated symptomatically and supportive measures instituted as required. Since pemafibrate is highly bound to plasma proteins, hemodialysis is unlikely to be of benefit.
3 years.
Do not store above 30ºC.
After the tablet is divided, store away from humidity, and use within 4 months.
PVC/Aluminium blisters in an aluminium-laminated bag, in a carton of 100 tablets (10 blisters x 10 tablets).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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