Fenostad 100

Rx

Indications

Adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

• Severe hypertriglyceridaemia with or without low HDL cholesterol.
• Mixed hyperlipidaemia when a statin is contraindicated or not tolerated or in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

Dosage
Adults

• The recommended dose is 200 mg daily.
• The dose can be titrated up to 267 mg daily. This maximum dose is not recommended in addition to a statin.

Special populations

• Elderly patients (≥ 65 years old)
  No dose adjustment is necessary. The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m².
• Renal impairment
  In patients with renal failure eGFR 30 – 59 mL/min/1.73 m², the dose of fenofibrate should not exceed 100 mg standard or 67 mg micronized once daily.

Paediatric population

• 1 capsule of Fenostad 67 (micronized)/day/20 kg body weight.

Usage

• Fenostad 100 should be swallowed whole during a meal.

• Hypersensitivity to any of the ingredients.
• Hepatic insufficiency.
• Known gallbladder disease.
• Severe renal insufficiency.
• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia,
• Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.

Common

• Abdominal pain, nausea, vomiting, diarrhoea, flatulence,
• Transaminases increased,
• Blood homocysteine level increased.

• Identify a secondary cause of hyperlipidaemia (pathological or drug-induced) and correct before fenofibrate therapy is considered. Monitor transaminases every 3 months during the first 12 months of treatment and thereafter periodically; Continuous monitoring of creatinine during the first 3 months after initiation of treatment and periodically thereafter.
• Risk of pancreatitis, muscle toxicity.
• Consider benefit/risk in patients with predisposing factors for myopathy/rhabdomyolysis (above 70 years of age, personal or familial history of hereditary muscular disorders, renal impairment, hypothyroidism and high alcohol intake).
• Discontinue if: AST/ALT > 3xULN or when symptoms of myalgia, myositis, muscle spasticity, weakness and/or CPK > 5xULN occur; creatinine > 50% ULN.
• In children: Only hereditary disease (familial hyperlipidemia) justifies early treatment, it is recommended to begin treatment with controlled dietary restrictions for a period of at least 3 months, consider medication only when signs of severity and/or in cases where patients suffer from atherosclerotic cardiovascular disease before the age of 40.
• Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Pregnancy, lactation: Use only after benefit/risk assessment.
• Patients should be aware of how they react to drug before driving or operating machinery.