Your Health, We Care
Another NameCamzyos,LuciMava,玛伐凯泰
IndicationsIt is indicated for the treatment of adult patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) classified as New York Heart Association (NYHA) Class Ⅱ-Ⅲ, to improve their functiona
Reg No.09 L 1198/24
Inspection NO.2128-24
Mavacamten manufactured by Lucius Pharmaceuticals is a novel cardiac myosin inhibitor. Targeting the pathological mechanism of obstructive hypertrophic cardiomyopathy (HCM), it boasts precise therapeutic advantages and favorable clinical value.
Mavacamten manufactured by Lucius Pharmaceuticals is a novel cardiac myosin inhibitor. Targeting the pathological mechanism of obstructive hypertrophic cardiomyopathy (HCM), it boasts precise therapeutic advantages and favorable clinical value.
Mavacamten reduces left ventricular ejection fraction (LVEF) and may cause heart failure due to systolic dysfunction.
An echocardiogram to assess LVEF is required prior to initiating and during treatment with Mavacamten. Initiation of CAMZYOS is not recommended in patients with LVEF <55%. Mavacamten treatment should be interrupted if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.
Concomitant use of Mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of Mavacamten is contraindicated with:
Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.
Because of the risk of heart failure due to systolic dysfunction, Mavacamten is available only through a restricted program called the Mavacamten REMS Program.
The use of Mavacamten is contraindicated with:
Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers
Heart Failure Mavacamten reduces myocardial contractility and may cause heart failure or significantly decrease ventricular function. Patients with serious intercurrent illnesses (e.g., serious infections) or arrhythmias (e.g., atrial fibrillation or other uncontrolled tachyarrhythmias) are at greater risk of developing systolic dysfunction and heart failure.
Assess patient clinical status and LVEF regularly during treatment and adjust the Mavacamten dose accordingly. New or worsening arrhythmias, dyspnea, chest pain, fatigue, palpitations, leg edema, or elevations in N-terminal pro–B-type natriuretic peptide (NT-proBNP) may be signs and symptoms of heart failure and should also prompt an evaluation of cardiac function.
Asymptomatic LVEF reduction, intercurrent illnesses, and arrhythmias require additional dosing considerations.
Initiation of CAMZYOS is not recommended in patients with LVEF <55%. Avoid concomitant use of Mavacamten in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker, as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and have limited clinical experience.
Mavacamten is primarily metabolized by CYP2C19 and CYP3A4 enzymes. Concomitant use of Mavacamten with drugs that impact these enzymes may lead to life-threatening drug interactions such as heart failure or loss of effectiveness.
Advise patients of the potential risk of drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). Advise patients to inform their healthcare provider of all concomitant products they are taking during treatment with Mavacamten, including when starting or stopping any product.
Because of the risk of heart failure due to systolic dysfunction, Mavacamten is available only through a restricted program called the Mavacamten REMS Program. Notable requirements of the program include:
Prescribers must be certified by enrolling in the REMS Program.
Patients must enroll in the REMS Program and comply with ongoing monitoring requirements.
Pharmacies must be certified by enrolling in the REMS Program and must only dispense to patients authorized to receive Mavacamten.
Wholesalers and distributors must only distribute to certified pharmacies.
Further information is available at www.CAMZYOSREMS.com or by telephone at 1-833-628-7367.
Based on animal studies, Mavacamten may cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential prior to initiation of Mavacamten and advise patients to use effective contraception during treatment with Mavacamten and for 4 months after the last dose. Combined hormonal contraceptives (CHCs) containing ethinyl estradiol and norethindrone may be used with Mavacamten. However, Mavacamten may decrease the effectiveness of certain other CHCs. If these CHCs are used, advise patients to add a nonhormonal contraceptive (e.g., condoms) during concomitant use and for 4 months after the last dose of Mavacamten.
In the EXPLORER-HCM trial, the adverse reaction occurring in >5% of patients and more commonly in the Mavacamten group than in the placebo group was dizziness (27% vs 18%) and syncope (6% vs 2%). No new adverse reactions were identified in the VALOR-HCM trial.
In the EXPLORER-HCM trial, the mean (SD) resting LVEF at baseline was 74% (6) for both treatment groups. The mean (SD) absolute change from baseline in LVEF over the 30-week treatment period was -4% (8) in the Mavacamten group and 0% (7) in the placebo group. At Week 38 (8 weeks after trial drug interruption), the mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, reversible reductions in LVEF to <50% (median 48%: range 35-49%) occurred during treatment in 7 (6%) patients in the Mavacamten group and in 2 (2%) patients in the placebo group. In all 7 Mavacamten-treated patients, LVEF recovered following interruption of Mavacamten.
Mavacamten is primarily metabolized by CYP2C19, and to a lesser extent by CYP3A4 and CYP2C9. Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect Mavacamten exposure.
Strong CYP2C19 Inhibitors: Concomitant use increases Mavacamten exposure, which may increase the risk of heart failure due to systolic dysfunction. Concomitant use is contraindicated.
Moderate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers: Concomitant use decreases Mavacamten exposure, which may reduce the effectiveness of Mavacamten. Following discontinuation of these inducers, as the induced enzyme levels normalize, the risk of heart failure due to systolic dysfunction may increase. Concomitant use is contraindicated.
Weak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors: Concomitant use with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases Mavacamten exposure, which may increase the risk of adverse drug reactions.
For patients on a stable dose of a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor, initiate Mavacamten at the recommended starting dosage of 5 mg orally once daily.
For patients on Mavacamten who are initiating a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor, reduce the Mavacamten dose by one level (i.e., 15 mg to 10 mg, 10 mg to 5 mg, or 5 mg to 2.5 mg).
Schedule clinical and echocardiographic assessment 4 weeks after inhibitor initiation and do not uptitrate Mavacamten for 12 weeks after inhibitor initiation.
For patients on a stable dose of 2.5 mg Mavacamten, avoid initiating concomitant weak CYP2C19 and moderate CYP3A4 inhibitors, because a lower dose is not available.
For short-term use (e.g., for 1 week), interrupt Mavacamten treatment during treatment with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Mavacamten may be reinitiated at the previous dose immediately following discontinuation of the concomitant medication.
Moderate CYP2C19 Inhibitors or Strong CYP3A4 Inhibitors: Concomitant use with a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor increases Mavacamten exposure, which may increase the risk of adverse drug reactions. Discontinuation of a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor after chronic concomitant use may decrease Mavacamten exposure, which may reduce the effectiveness of Mavacamten.
For patients on a stable dose of a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor, initiate Mavacamten at a starting dosage of 2.5 mg orally once daily.
For patients on Mavacamten who are initiating a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor, reduce the Mavacamten dose by one level (i.e., 15 mg to 10 mg, 10 mg to 5 mg, or 5 mg to 2.5 mg).
For patients on a stable dose of 2.5 mg Mavacamten, avoid initiating concomitant moderate CYP2C19 and strong CYP3A4 inhibitors, because a lower dose is not available.
If a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor is discontinued after chronic concomitant use, an increase in the Mavacamten dose may be required. Monitor for new or worsening symptoms.
For short-term use (i.e., when a Mavacamten dose adjustment is not feasible), interrupt Mavacamten treatment during treatment with a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Mavacamten may be reinitiated at the previous dose immediately following discontinuation of the concomitant medication.
Mavacamten is an inducer of CYP3A4, CYP2C9, and CYP2C19. Concomitant use with CYP3A4, CYP2C9, or CYP2C19 substrates may reduce the plasma concentrations of these drugs. Monitor closely when Mavacamten is used concomitantly with CYP3A4, CYP2C9, or CYP2C19 substrates unless otherwise recommended in their prescribing information.
Certain Combined Hormonal Contraceptives (CHCs): Progestins and ethinyl estradiol are CYP3A4 substrates. Concomitant use with Mavacamten may decrease exposures of certain progestins, which may lead to contraceptive failure. CHCs containing ethinyl estradiol and norethindrone may be used with Mavacamten, but if other CHCs are used, advise patients to add a nonhormonal contraceptive (e.g., condoms) or use an alternative contraceptive method unaffected by CYP450 enzyme induction (e.g., intrauterine system) during concomitant use and for 4 months after the last dose of Mavacamten.
Mavacamten is expected to have additive negative inotropic effects when used concomitantly with other drugs that reduce cardiac contractility. Avoid concomitant use of Mavacamten in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker, as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and have limited clinical experience.
If concomitant therapy with a negative inotrope is initiated, or if the dose of a negative inotrope is increased, monitor LVEF closely until stable doses and clinical response have been achieved.
Mavacamten may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus with maternal exposure to Mavacamten during pregnancy. There is a pregnancy safety study for Mavacamten. If CAMZYOS is used during pregnancy or if a patient becomes pregnant while taking Mavacamten or within 4 months after the last dose, healthcare providers should report Mavacamten exposure by contacting Bristol Myers Squibb at 1-800-721-5072 or www.bms.com.
It is not known whether Mavacamten is present in human or animal milk, affects the breastfed infant, or affects milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Mavacamten and any potential adverse effects on the breastfed child from Mavacamten or from the underlying maternal condition.
Verify pregnancy status in females of reproductive potential prior to initiation of Mavacamten. Advise females of reproductive potential to use effective contraception during treatment with Mavacamten and for 4 months after the last dose. CHCs containing ethinyl estradiol and norethindrone may be used with Mavacamten. However, Mavacamten may decrease the effectiveness of certain other CHCs. If these CHCs are used, advise patients to add a nonhormonal contraceptive (e.g., condoms) or use an alternative contraceptive method during concomitant use and for 4 months after the last dose of Mavacamten.
CAMZYOS® (mavacamten) 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.
FDA，2025.04
