HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciMava safely and effectively. See full prescribing information for LuciMava.

INDICATIONS AND USAGE

LuciMava is a cardiac myosin inhibitor 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.

DOSAGE AND ADMINISTRATION

Dosage must be individualized based on clinical status and echocardiographic assessment of patient response. Refer to the Full Prescribing Information for instructions.

DOSAGE FORMS AND STRENGTHS

Capsules: 2.5mg×60 capsules

CONTRAINDICATIONS

• Moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors.

• Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

WARNINGS AND PRECAUTIONS

• Heart Failure: Consider interruption of LuciMava (mavacamten) in patients with intercurrent illness.

• Drug Interactions Leading to Heart Failure or Loss of Effectiveness: Advise patients of the potential for drug interactions including with over-the-counter medications.

• Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential to use effective contraception until 4 months after the last dose. Use a contraceptive not affected by CYP450 enzyme induction or add nonhormonal contraception.

ADVERSE REACTIONS

Adverse reactions occurring in >5% of patients and more commonly on LuciMava than on placebo were dizziness (27%) and syncope (6%).

DRUG INTERACTIONS

• Weak CYP2C19 inhibitors and moderate CYP3A4 inhibitors: May increase risk of heart failure. If initiating an inhibitor, LuciMava dose reduction and additional monitoring are required.

• Negative inotropes: Close medical supervision and LVEF monitoring is recommended if a negative inotrope is initiated, or the dose of a negative inotrope is increased. Avoid certain combinations of negative inotropes.

USE IN SPECIFIC POPULATIONS

See full prescribing information.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.