Mavacamten

FDA label

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Titration Assess LVEF and Valsalva LVOT gradient before each up-titration (weeks to steady state); when on an interacting inhibitor, do not up-titrate until 12 weeks after inhibitor initiation.

Renal Undefined

Hepatic No adjustment for mild–moderate (Child-Pugh A/B) with the standard titration/monitoring plan; severe (Child-Pugh C) unknown.

Available only through the CAMZYOS REMS Program.

Instructions

• Swallow capsules whole; do not break, open, or chew.
• Take once daily with or without food.
• Confirm absence of pregnancy and use effective contraception before starting.
• If a dose is missed, take when remembered; do not take two doses the same day.
• Interrupt treatment if LVEF <50% or on worsening clinical status.

Contraindications

• Concomitant strong CYP2C19 inhibitors.
• Concomitant moderate-to-strong CYP2C19 inducers or moderate-to-strong CYP3A4 inducers.

Cautions

• Heart failure due to systolic dysfunction; higher risk with intercurrent illness or arrhythmia.
• CYP2C19/CYP3A4 drug interactions leading to heart failure or loss of effectiveness.
• Embryo-fetal toxicity; may reduce effectiveness of some hormonal contraceptives.
• Avoid with disopyramide, ranolazine, or verapamil/diltiazem plus a beta blocker.

Adverse reactions

• dizziness (27%)
• syncope (6%)

Pregnancy May cause fetal harm (animal data); confirm absence of pregnancy before starting and use contraception during and 4 months after last dose.

Lactation No data on presence in milk or effects on infant/production; weigh benefits.