What are the precautions for mavacamten?

In clinical studies of mavacamten (mavacamten) in the treatment of obstructive hypertrophic cardiomyopathy (HCM), warnings and precautions such as heart failure, drug interactions, and embryo-fetal toxicity have emerged. The drug should be discontinued and resumed at a reduced dose after recovery, or permanently discontinued depending on the severity. Mavaceta should be purchased through relevant plans under the guidance of a doctor.

1. Heart failure: Mavaceta will reduce cardiac contraction and may lead to heart failure or completely block ventricular function. Patients with serious intercurrent illnesses (eg, severe infection) or cardiac arrhythmias (eg, atrial fibrillation or other uncontrolled tachyarrhythmias) are at greater risk of developing systolic dysfunction and heart failure. Assess the patient's clinical status and left ventricular ejection fraction (LVEF) before and periodically during treatment, and adjust the dose of Mavacartide accordingly. New or worsening cardiac arrhythmias, dyspnea, chest pain, fatigue, palpitations, leg edema, or elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) may be signs and symptoms of heart failure and should also prompt evaluation of cardiac function. Asymptomatic LVEF reduction, intercurrent illness, and arrhythmias require additional dosing considerations.

It is not recommendedPatients with LVEF <55% to start taking Mavaceta. Avoid concomitant use of carbamazepine, ranolazine, verapamil, and a beta-blocker, or diltiazem and a beta-blocker, as these drugs and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms, and clinical experience is limited.

2. CYP450 drug interactions leading to heart failure or failure: Mavaceta is mainly metabolized by CYP2C19 and CYP3A4 enzymes. Concomitant use of Mavacartide with drugs that interact with these enzymes may result in life-threatening drug interactions such as heart failure or failure. Inform patients of the possibility of drug interactions, including interactions with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). Advise patients to inform their healthcare provider of all concomitant products before and during treatment with MAVACARTA.

3. Mavaceta REMS Plan: Due to the risk of heart failure due to systolic dysfunction, Mavaceta is only available through a restricted plan called the Mavaceta REMS plan. Notable requirements of the MAVACATILE REMS program include: prescribers must be certified by participating in the MAVACATILE REMS program; patients must be enrolled in the MAVACATARI REMS program and comply with ongoing monitoring requirements; pharmacies must be certified by enrolling in the MAVAGATARI REMS program and must only dispense prescriptions to patients authorized to receive MAVACATILE; and wholesalers and distributors must distribute only to certified pharmacies.

4. Embryo-fetal toxicity: According to animal studies, pregnant women taking Mavaceta may cause fetal poisoning. Confirm that females of reproductive potential are not pregnant prior to treatment and advise patients to use effective contraception during treatment with Mavacartide and for 4 months after the last dose. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with mavacamten. However, mavacate may reduce the effectiveness of certain other combined hormonal contraceptives (CHCs). If these CHCs are used, advise patients to add non-hormonal contraceptives (e.g., condoms) during concomitant use and for 4 months after the last dose of MAVACARTA.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=669c936b-3ee6-4e36-8a22-79dd11b1255b