Safety profile | CAMZYOS UK

The safety profile of CAMZYOS was evaluated in the Phase 3 EXPLORER-HCM and VALOR-HCM trials across a total of 179 patients with symptomatic obstructive HCM.^1–3 The median treatment duration for patients receiving CAMZYOS was 30.1 weeks (range: 1.6–40.3 weeks).¹

Most commonly reported adverse reactions with CAMZYOS¹

5% (9/179) of patients in the CAMZYOS group experienced reversible reductions in
LVEF <50% (median 45%: range 35–49%) while on treatment¹

In 56% (5/9) of these patients, these reductions were observed without other clinical manifestations¹
In all patients treated with CAMZYOS, LVEF recovered following treatment interruption and they completed the study on CAMZYOS¹

*Systolic dysfunction is defined as LVEF <50% with or without symptoms.¹

Dyspnoea was reported in 12.3% (22/179) of patients treated with CAMZYOS vs 8.7% (16/184) of patients on placebo¹

In the EXPLORER-HCM study, 67% of dyspnoea events were reported after CAMZYOS was discontinued, with median time to onset of 2 weeks (range: 0.1–4.9) after last dose¹

CAMZYOS was generally well tolerated in the Phase 3 EXPLORER-HCM trial, with few patients discontinuing their treatment^1,2

(244/251) completion rate in the EXPLORER-HCM trial across both treatment groups at Week 30²

Most common serious adverse events in EXPLORER-HCM with CAMZYOS²

Rates of treatment discontinuation in the EXPLORER-HCM trial were low with CAMZYOS (2%;n=3/123) and comparable to placebo (2%;n=2/128)²

See CAMZYOS dosing

Please refer to the CAMZYOS Summary of Product Characteristics for further information on dosing, initiation and safety.

HCM, hypertrophic cardiomyopathy; LVEF, left ventricular ejection fraction.

References

CAMZYOS (mavacamten) Summary of Product Characteristics.
Olivotto I et al. Lancet. 2020;396(10253):759–769.
Desai MY et al. J Am Coll Cardiol. 2022;80(2):95–108.