Mavacamten

1 INDICATIONS AND USAGE CAMZYOS ® is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. CAMZYOS is a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. ( 1 )

6 ADVERSE REACTIONS The following adverse reaction is discussed in other sections of the labeling: • Heart failure [see Warnings and Precautions (5.1) ] Adverse reactions occurring in >5% of patients and more commonly on CAMZYOS than on placebo were dizziness (27%) and syncope (6%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

8.1 Pregnancy Risk Summary Based on animal data, CAMZYOS may cause fetal harm when administered to a pregnant female. There are no human data on the use of CAMZYOS during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. The underlying maternal condition during pregnancy poses a risk to the mother and fetus (see Clinical Considerations ) . Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy.

WARNING: RISK OF HEART FAILURE CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction [see Warnings and Precautions (5.1) ] . Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. 5 WARNINGS AND PRECAUTIONS • Heart Failure : Consider interruption of CAMZYOS in patients with intercurrent illness. ( 2.1 , 5.1 ) • Drug Interactions Leading to Heart Failure or Loss of Effectiveness : Advise patients of the potential for drug interactions including with over-the-counter medications. ( 4 , 5.2 , 17 ) • Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential to use effective contraception until 4 months after the last dose. Avoid concomitant use with a combined hormonal contraceptive that contains a progestin other than norethindrone. ( 5.4 , 7.2 , 8.1 , 8.3 ) 5.1 Heart Failure CAMZYOS reduces systolic contraction and can cause heart failure or significantly reduce ventricular function. 4 CONTRAINDICATIONS CAMZYOS is contraindicated with concomitant use of: • Strong CYP2C19 inhibitors [see Warnings and Precautions (5.2) , Drug Interactions (7.1) ] • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers [see Warnings and Precautions (5.2) , Drug Interactions (7.1) ] • Strong CYP2C19 inhibitors.