Hormonal Contraceptives: Progestin and ethinyl estradiol are CYP3A4 substrates. Closely monitor when Camzyos is used in combination with CYP3A4, CYP2C19, or CYP2C9 substrates where decreases in the plasma concentration of these drugs may reduce their activity. Concomitant use with CYP3A4, CYP2C19, or CYP2C9 substrates may reduce plasma concentration of these drugs. Potential for Camzyos to Affect Plasma Concentrations of Other DrugsĬamzyos is an inducer of CYP3A4, CYP2C9, and CYP2C19. Avoid initiation of concomitant weak CYP2C19 and moderate CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg of Camzyos because a lower dose is not available. Schedule clinical and echocardiographic assessment 4 weeks after inhibitor initiation, and do not up-titrate Camzyos until 12 weeks after inhibitor initiation. Reduce dose of Camzyos by one level (i.e., 15 to 10mg, 10 to 5 mg, or 5 to 2.5 mg) in patients who are on Camzyos treatment and intend to initiate a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Initiate Camzyos at the recommended starting dose of 5 mg orally once daily in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Weak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors: Concomitant use with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases Camzyos exposure, which may increase the risk of adverse drug reactions. The risk of heart failure due to systolic dysfunction may increase with discontinuation of these inducers as the levels of induced enzyme normalizes. Moderate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers: Concomitant use decreases Camzyos exposure, which may reduce Camzyos’ efficacy. Moderate to Strong CYP2C19 Inhibitors or Strong CYP3A4 Inhibitors: Concomitant use increases Camzyos exposure, which may increase the risk of heart failure due to systolic dysfunction. Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect the exposures of Camzyos. Potential for Other Drugs to Affect Plasma Concentrations of CamzyosĬamzyos is primarily metabolized by CYP2C19 and to a lesser extent by CYP3A4 and CYP2C9. In all 7 patients treated with Camzyos, LVEF recovered following interruption of Camzyos. In the EXPLORER-HCM trial, 7 (6%) patients in the Camzyos group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the Camzyos group and 0% (7) in the placebo group over the 30-week treatment period. In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Additionally, 7 (6%) patients in the Camzyos group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF to 5% of patients and more commonly in the Camzyos group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%). Mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Initiation of Camzyos in patients with LVEF 5% of patients and more commonly in the Camzyos group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%). Echocardiogram assessments of LVEF are required prior to and during treatment with Camzyos. Camzyos reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Prescribing Information for Camzyos includes a Boxed WARNING for the risk of heart failure. cardiologists now have a new pharmacological option for eligible patients that targets the underlying pathophysiology of the disease.” “This is a first-in-class medicine specifically for patients living with symptomatic obstructive HCM,” said Milind Desai, M.D., MBA, director of the Hypertrophic Cardiomyopathy Center and director of clinical operations in Cleveland Clinic’s Heart Vascular & Thoracic Institute.
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