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).
MAVA-LTE: Long-term open-label extension of the EXPLORER-HCM trial:
No new safety concerns identified
Study of patients who completed the EXPLORER-HCM trial (N=224); mean duration 32 weeks.1
- 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).
The duration of this study is longer than the data in the Product Monograph.
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.
VALOR-HCM long-term extension period:
CAMZYOS was well-tolerated through Week 128
- Patients who completed the 16-week placebo-controlled period in VALOR-HCM where all patients received CAMZYOS (N=108). After a mean duration of 32 weeks, ~half of patients had 32 weeks of mavacamten exposure at the time of data analysis. The most common reported adverse events included dizziness (9.3%), fatigue (8.3%) and atrial fibrillation (7.4%). No patients that previously received 16 weeks of mavacamten had cardiac failure.
- Two patients in the previous placebo group who received CAMZYOS in the LTE had LVEF below 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 mavacamten discontinuation.
The duration of this study is longer than the data in the Product Monograph.
HCM=hypertrophic cardiomyopathy; oHCM=obstructive hypertrophic cardiomyopathy; LTE=long-term extension
DRUG-DRUG INTERACTIONS
Drug-drug interactions1
Serious drug interactions
CAMZYOS is contraindicated in patients who are receiving:
- concomitant use of strong cytochrome P450 (CYP) enzyme CYP2C19 inhibitors, due to risk of developing left ventricular dysfunction.
- concomitant use of moderate or strong inducers to both CYP2C19 and CYP3A4, due to risk of loss of therapeutic effect.
Drug interactions overview
- CAMZYOS is primarily metabolized by CYP2C19 and to a lesser extent by CYP3A4.
- Moderate and strong CYP3A4 inhibitors/inducers or CYP2C19 inhibitors/inducers may significantly affect the exposure of CAMZYOS.
- Refer to Concomitant therapy in the Product Monograph for details on CAMZYOS dose modification or interruption with certain concomitant medications.
Established or potential drug-drug interactions*
Adapted from the Product Monograph.
Established or potential drug-drug interactions are 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).
Consult the Product Monograph for more information regarding drug-behaviour interactions on transporters, CYP enzyme substrates, and drugs that reduce cardiac contractility.
LVEF=left ventricular ejection fraction
Reference: 1. CAMZYOS (mavacamten capsules) Product Monograph. Bristol Myers Squibb Canada.