Indication and clinical use:
CAMZYOS (mavacamten capsules) is indicated for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) Class II-III in adult patients.
- Studies of CAMZYOS suggest that safety, effectiveness, and pharmacokinetics were consistent between elderly patients (≥65 years) and younger patients (18 to <65 years).
- The safety and efficacy of CAMZYOS in children <18 years of age have not been established.
Contraindications:
CAMZYOS is contraindicated:
- with concomitant use of moderate or strong cytochrome P450 (CYP) enzyme CYP2C19 inhibitors, or strong CYP3A4 inhibitors, due to risk of developing left ventricular dysfunction
- with concomitant use of moderate or strong inducers to both CYP2C19 and CYP3A4 due to risk of loss of therapeutic effect
- during pregnancy
- in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Most serious warnings and precautions:
Risk of heart failure: CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Echocardiogram assessments of LVEF and left ventricular outflow tract (LVOT) gradient are required prior to, and regularly during, treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS treatment if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status. Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors may increase the risk of heart failure due to systolic dysfunction.
Other relevant warnings and precautions:
- Heart failure due to systolic dysfunction; monitor patients with intercurrent illness (e.g., serious infections, clinically relevant arrhythmias) or those undergoing major cardiac surgery for signs or symptoms of heart failure or elevation in NT-proBNP
- Risk of heart failure or loss of response due to drug-drug interactions
- Safety of concomitant use with drugs that reduce cardiac contractility (disopyramide; ranolazine; beta blockers + calcium channel blockers) not fully established; expect additive negative inotropic effect
- Not recommended in patients on dual/triple therapy with negative inotropic agents (calcium channel blocker or disopyramide + beta blocker; disopyramide + beta blocker + calcium channel blocker); could increase risk of LV systolic dysfunction and heart failure symptoms
- If concomitant therapy with any negative inotrope is initiated with CAMZYOS or dose of a negative inotrope is increased, monitor closely for systolic dysfunction/LVEF until stable doses and stable clinical response
- Driving and operating machinery
- Teratogenic risk
- Females of reproductive potential: confirm negative pregnancy test prior to treatment initiation; use highly effective contraception during treatment with CAMZYOS and for at least 4 months after discontinuation
- Breastfeeding
- Severe renal impairment (eGFR <30 mL/min/1.73 m2)
- Not recommended in severe hepatic impairment (Child-Pugh Class C)
For more information:
Consult the Product Monograph for important information relating to adverse reactions, drug interactions and dosing.
The Product Monograph is also available by calling 1-866-463-6267.