Mibeaz Special Precautions

Elevated hepatic transaminase: A higher incidence of elevated transaminases (3 or more times the upper limit of normal [ULN]) has been observed with concomitant use of ezetimibe and statins compared to statin monotherapy. Consider discontinuation of ezetimibe and/or the statin for persistently evaluated transaminase (ALT or AST 3 or more times the ULN).
Myopathy and rhabdomyolysis: Myopathy, including rhabdomyolysis, has been reported (rarely) with ezetimibe monotherapy. Risk may be increased with concomitant use of a statin or fibrate. Moreover, risk may be increased with patients older than 65 years of age, patients with hypothyroidism, higher dosage of statin. Discontinue ezetimibe and statins or fibrate immediately if myopathy is suspected or confirmed (symptomatic patient with creatinine phosphokinase more than 10 times the ULN).
Renal function impairment: Use with caution in patients with severe renal impairment (CrCl 30 mL/min/ 1.73 m² or less). If using concurrent simvastatin in patients with moderate to severe renal impairment (CrCl less than 60 mL/min/1.73 m²) simvastatin dose exceeding 20 mg may be used with caution and close monitoring for adverse events (e.g. myopathy).
Hepatic function impairment: Use with caution in patients with mild hepatic impairment (Child-Pugh score 5 to 6, class A). Use is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh score 7 to 9, class B or Child-Pugh score >9, class C).