Camzyos

Mavacamten

Symptomatic (NYHA class II-III) obstructive hypertrophic cardiomyopathy in adults.

Dose range: 2.5-15 mg. CYP2C19 poor metaboliser phenotype Initially 2.5 mg once daily. Max: 5 mg once daily. CYP2C19 intermediate, normal, rapid & ultra-rapid metaboliser phenotype Initially 5 mg once daily. Max: 15 mg once daily. Patient w/ mild (Child-Pugh class A) & moderate (Child-Pugh class B) hepatic impairment Starting dose: 2.5 mg.

May be taken with or without food: Swallow whole w/ water.

Hypersensitivity. Concomitant treatment w/ strong CYP3A4 inhibitors in patients w/ CYP2C19 poor metaboliser phenotype & undetermined CYP2C19 phenotype. Concomitant treatment w/ combination of a strong CYP2C19 inhibitor & a strong CYP3A4 inhibitor. Women of childbearing potential not using effective contraception. Pregnancy.

Patient should be genotyped for CYP2C19 to determine appropriate dose. Patients w/ CYP2C19 poor metaboliser phenotype may have increased mavacamten exposures. Reduces left ventricular ejection fraction (LVEF) & may cause heart failure due to systolic dysfunction defined as symptomatic LVEF <50%. Measure LVEF prior to treatment initiation & closely monitor thereafter. Risk of heart failure or loss of response to mavacamten due to interactions w/ CYP2C19 or CYP3A4 inhibitors/inducers. Safety of concomitant use w/ disopyramide, or use in patients taking β-blockers in combination w/ verapamil or diltiazem has not been established; patients should be closely monitored when taking these concomitant medicinal products. Minor influence on the ability to drive & use machines. Has not been studied in patients w/ severe renal or severe hepatic impairment. May cause embryo-fetal toxicity. Women of childbearing potential must have a -ve pregnancy test prior to treatment & must use effective contraception during treatment & for 6 mth after treatment discontinuation. Women must not breast-feed during treatment. Safety & efficacy in childn & adolescents <18 yr have not been established. Should not be used in childn <12 yr.

Dizziness; dyspnoea. Systolic dysfunction; syncope.

Potential pharmacodynamic interactions w/ -ve inotropes. Increased risk of heart failure due to systolic dysfunction w/ strong or moderate CYP3A4 inhibitor or any CYP2C19 inhibitor. Loss of therapeutic response w/ strong CYP3A4 or strong CYP2C19 inducer. Dose adjustment of mavacamten &/or close monitoring may be required in patients initiating or discontinuing treatment w/, or changing the dose of concomitant medicinal products that are inhibitors or inducers of CYP2C19 or CYP3A4; intermittent administration of these medicinal products is not recommended.

Other Cardiovascular Drugs

C01EB24 - mavacamten ; Belongs to the class of other cardiac preparations.

P₁S₁S₃