Most commonly reported on-treatment adverse reactions in CAMZYOS-treated patients1
- Dizziness (17.1% vs. 11.7% placebo)
- Headache (11.4% vs. 7.8% placebo)
Adverse events in ≥5% of CAMZYOS-treated patients (EXPLORER-HCM at Week 30)1
Adapted from the Product Monograph.
Serious adverse events: Observed in 8.1% of CAMZYOS-treated patients and 8.6% of placebo-treated patients to Week 30
Discontinuation: Study drug was permanently discontinued in 1.6% of CAMZYOS-treated patients due to adverse events (one patient with syncope, one with atrial fibrillation).
Long-term open-label extension trial safety profile1
- N=224 patients who completed the EXPLORER-HCM trial; mean duration 32 weeks.
- Most commonly reported adverse reactions: fatigue (6.7%), atrial fibrillation (4.9%), headache (4.9%), dyspnea (4.5%), and dizziness (4.0%).
- Serious adverse events: Reported in 8.5% of patients (3 cases of cardiac failure [all resolved]; 2 cases of atrial fibrillation).
LVEF=left ventricular ejection fraction
VALOR-HCM SAFETY PROFILE
CAMZYOS was generally well tolerated in the VALOR-HCM trial1
Adverse events in ≥5% of CAMZYOS-treated patients (VALOR-HCM at Week 16)1
Adapted from the Product Monograph.
There was no permanent discontinuation due to adverse events in VALOR-HCM.
Long-term open-label extension trial safety profile1*
- Most common adverse events included dizziness (9.3%), fatigue (8.3%) and atrial fibrillation (7.4%).
- No patients that previously received 16 weeks of CAMZYOS treatment had cardiac failure.
Two patients in the previous placebo group who received CAMZYOS in the LTE had LVEF <30%. At Week 32 (after 16 weeks of CAMZYOS treatment), one of these patients had heart failure due to uncontrolled atrial fibrillation with rapid ventricular response (RVR), requiring hospitalization. At Week 56 (after 40 weeks of CAMZYOS treatment), one patient experienced sudden cardiac death, a known complication of HCM, 5 days after CAMZYOS discontinuation.
HCM=hypertrophic cardiomyopathy; oHCM=obstructive hypertrophic cardiomyopathy; LTE=long-term extension
* LTE period: 108 CAMZYOS-treated oHCM patients who completed the 16-week placebo-controlled period in VALOR-HCM. After a mean duration of 32 weeks, approximately half of patients had 32 weeks of CAMZYOS exposure at the time of data analysis.
Established or potential drug-drug-interactions*
Adapted from the Product Monograph.
Consult the Product Monograph for interactions with drugs that reduce cardiac contractility and CYP enzyme substrates.
LVEF=left ventricular ejection fraction
* Based on drug interaction case reports or studies, or potential interactions due to the expected magnitude and seriousness of the interaction (i.e., those identified as contraindicated).
Reference: 1. CAMZYOS (mavacamten capsules) Product Monograph. Bristol Myers Squibb Canada, February 14, 2024.