Grofibrat S (Fenofibrate Micronised)

Grofibrat S is indicated for the management of several lipid disorders, typically when diet and lifestyle changes alone are insufficient.

• Primary treatment of hypertriglyceridemia to lower elevated triglyceride levels.
• Adjunct therapy for mixed dyslipidemia, addressing high triglycerides and low HDL‑cholesterol.
• Used together with statins for patients with hypercholesterolemia who need additional triglyceride reduction.
• May be prescribed for patients with familial combined hyperlipidemia when other agents are inadequate.
• Helps reduce the risk of pancreatitis associated with severe hypertriglyceridemia.

The safety profile of Grofibrat S includes both frequently observed and less common adverse reactions that may require medical attention.

Common

• Gastrointestinal discomfort such as abdominal pain, nausea, dyspepsia, or loose stools, which are usually mild and transient.
• Muscle aches, tenderness, or weakness, particularly when the drug is used together with a statin.
• Mild elevations in liver enzymes (ALT/AST) indicating temporary hepatic stress.
• Headache, dizziness, or fatigue that may improve with continued therapy.

Serious

• Rhabdomyolysis, a rare but severe breakdown of muscle tissue that can lead to myoglobinuria and acute kidney injury.
• Acute liver injury presenting with jaundice, marked enzyme elevation, or hepatic failure, requiring immediate medical evaluation.
• Severe hypersensitivity reactions such as rash, pruritus, angio‑edema, or anaphylaxis.

Before prescribing Grofibrat S, clinicians should evaluate several patient‑specific factors to minimize risks and ensure appropriate use.

• Assess liver function; avoid in active hepatic disease or unexplained persistent transaminase elevations.
• Evaluate renal function; dose adjustment may be required in moderate to severe impairment.
• Review concomitant drugs that increase myopathy risk, especially statins or gemfibrozil.
• Avoid use in pregnancy and lactation unless benefits outweigh risks, as safety data are limited.
• Monitor lipid profile and liver enzymes periodically during treatment.
• Caution in patients with a history of gallstones, as fenofibrate may promote biliary sludge formation.

Grofibrat S can interact with several medicines, influencing its efficacy or increasing the risk of adverse effects.

Avoid

• Gemfibrozil, because combined use markedly raises the risk of myopathy and rhabdomyolysis.
• High-dose statins (e.g., simvastatin >40 mg) when used together may increase muscle toxicity.
• Cyclosporine, which can raise fenofibrate plasma concentrations.
• Concomitant use with cholestyramine or colestipol may reduce fenofibrate absorption, decreasing its lipid‑lowering effect.

Use with caution

• Anticoagulants (warfarin) – fenofibrate may enhance anticoagulant effect, requiring INR monitoring.
• Oral hypoglycemic agents – fenofibrate can potentiate glucose‑lowering, risking hypoglycemia.
• Thyroid hormone replacement – may alter thyroid hormone levels, necessitating dose adjustment.
• Protease inhibitors – may increase fenofibrate levels, so monitor for toxicity.