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Fibrate (PPAR-α agonist) Pregnancy: Contraindicated — animal teratogenicity; pause during pregnancy/breastfeeding.

Bezafibrate

Brand names: Bezalip Mono, Bezalip

Adult dose

Dose: 200 mg TDS with or after food, OR 400 mg OD modified-release (Bezalip Mono).
Route: Oral
Frequency: Once daily (MR) or three times daily
Max: 600 mg/day
Take with food to reduce GI upset.

Dose adjustments

Renal

eGFR 60–89: 400 mg OD or 200 mg BD. eGFR 40–59: 200 mg BD. eGFR 15–39: 200 mg every 1–2 days. eGFR <15 or dialysis: avoid.

Hepatic

Avoid in significant hepatic impairment, biliary cirrhosis, or gallbladder disease.

Clinical pearls

  • Modest cardiovascular benefit — primary niche is severe hypertriglyceridaemia (TG >10 mmol/L) for pancreatitis prevention.
  • ACCORD (NEJM 2010) showed no overall CV benefit for fenofibrate added to statin in T2DM, but subgroup with TG >2.3 + low HDL did benefit — fibrate not first-line.
  • Stop immediately if myalgia + ↑ CK >5× ULN; rhabdomyolysis risk high in CKD, hypothyroidism, elderly.
  • Always check TFTs and treat hypothyroidism (which itself causes hypertriglyceridaemia) before adding a fibrate.
  • ↑ Creatinine on bezafibrate is typically a tubular secretion effect, not GFR loss — confirm with cystatin C if relevant.

Contraindications

  • Severe renal impairment (eGFR <15 ml/min)
  • Severe hepatic impairment, biliary cirrhosis
  • Gallbladder disease, gallstones
  • Hypersensitivity to fibrates
  • Pre-existing photosensitivity reaction with fibrates
  • Pregnancy and breastfeeding

Side effects

  • GI upset: dyspepsia, nausea, abdominal pain
  • Myalgia, myositis, rhabdomyolysis (especially with statins, in renal impairment, or hypothyroidism)
  • ↑ Creatinine (often without true GFR change)
  • Cholelithiasis
  • Hepatotoxicity (raised transaminases)
  • Photosensitivity
  • ↑ Homocysteine
  • Headache, fatigue, sexual dysfunction

Interactions

  • Statins: ↑ rhabdomyolysis risk (gemfibrozil worse — bezafibrate is the preferred fibrate to combine with a statin if absolutely necessary, under specialist guidance)
  • Warfarin: ↑ INR — reduce warfarin by ~50% and check INR closely
  • Sulphonylureas / repaglinide / insulin: ↑ hypoglycaemia
  • Ciclosporin: ↓ efficacy of fibrate, ↑ ciclosporin nephrotoxicity
  • Bile acid sequestrants (colestyramine): separate by 2 hours

Monitoring

  • LFTs at baseline, 3 months, then annually
  • U&Es 3-monthly
  • CK if myalgia
  • Lipid profile at 3 months

Reference: BNF 90; SmPC Bezalip Mono; ACCORD Lipid trial NEJM 2010;362:1563-74; NICE CG181; ESC/EAS Dyslipidaemias 2019. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

Pathways