Grofibrat M (Fenofibrate)

Grofibrat M is indicated for the management of several lipid disorders in adults, particularly when dietary measures alone have not achieved target levels.

• Treatment of primary hypercholesterolemia to lower LDL‑cholesterol levels.
• Reduction of elevated triglyceride concentrations in hypertriglyceridemia.
• Management of mixed dyslipidemia with combined high cholesterol and triglycerides.
• Adjunctive therapy for patients at risk of cardiovascular events when lifestyle measures are inadequate.
• Use in combination with statins for enhanced lipid control under physician guidance.
• Treatment of secondary dyslipidemia associated with diabetes mellitus.
• Management of lipid abnormalities in metabolic syndrome.

Like other fibrates, Grofibrat M may cause a range of adverse effects. Most are mild, dose‑related, and reversible, but patients should be aware of the typical symptoms that can arise during therapy. Patients should report any persistent or worsening symptoms to their healthcare provider, especially if they involve muscle pain, weakness, or signs of liver dysfunction.

Common

• Mild gastrointestinal discomfort such as nausea or abdominal pain
• Headache
• Elevated liver enzymes (transient)
• Muscle cramps
• Dizziness
• Fatigue
• Sleep disturbances
• Dry mouth

Serious

• Severe muscle injury (rhabdomyolysis)
• Significant liver injury
• Allergic reactions including rash or angioedema
• Acute kidney injury (rare)
• Blood clotting abnormalities (rare)
• Severe pancreatitis (very rare)

Precautions for Grofibrat M focus on patient selection, monitoring, and conditions that may increase the risk of adverse events. Before starting therapy, clinicians should evaluate liver and kidney function, review concomitant medications, and consider the patient’s overall cardiovascular risk profile.

• Check liver enzymes and kidney function; avoid in severe hepatic impairment.
• Monitor lipid profile, liver tests, and creatinine regularly while on therapy.
• Use caution if patient has gallstones or biliary disease.
• Avoid if known hypersensitivity to fenofibrate or other fibrates.
• Pregnancy and breastfeeding safety are unknown; prescribe only when benefits outweigh risks.

Grofibrat M can interact with several medicines, affecting its efficacy or increasing toxicity. Recognizing these interactions helps clinicians manage therapy safely. Interactions may alter drug concentrations, increase the risk of muscle damage, affect coagulation, or modify lipid outcomes, so dose adjustments or additional monitoring may be required.

Avoid

• Concurrent use with gemfibrozil, as it markedly raises fenofibrate plasma levels and risk of myopathy.
• Co‑administration with strong CYP3A4 inhibitors (e.g., ketoconazole) that can increase exposure.

Use with caution

• Statins (especially simvastatin) – monitor for muscle toxicity.
• Warfarin – may enhance anticoagulant effect; monitor INR.
• Oral contraceptives – may slightly increase triglyceride levels; observe lipid response.