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Initiation of treatment or dose escalation of mavacamten is not recommended for patients with a left ventricular ejection fraction (LVEF) below 55%.
The recommended starting dose is 5 mg orally once daily, administered without regard to food intake. Subsequent titration doses permitted are 2.5 mg, 5 mg, 10 mg, or 15 mg orally once daily. The maximum recommended dose is 15 mg orally once daily.
Heart failure may occur in patients during mavacamten treatment. Regular assessments of left ventricular ejection fraction (LVEF) and Valsalva left ventricular outflow tract (LVOT) gradient are required to carefully titrate the dose to achieve the target Valsalva LVOT gradient, while maintaining LVEF at no less than 50% and preventing the onset of heart failure symptoms.
Steady-state drug levels and therapeutic effects may take several weeks to achieve with daily administration. Additionally, genetic variations in metabolism and drug-drug interactions can result in substantial variability in drug exposure.
When initiating or adjusting the mavacamten dose, prioritize the assessment of LVEF, followed by Valsalva LVOT gradient and the patient’s clinical status, to guide appropriate mavacamten dosing. For symptomatic patients with a normal or near-normal Valsalva gradient (approximately 30 mmHg) prior to starting mavacamten, consideration may be given to assessing the post-exercise LVOT gradient. Follow the initiation and maintenance phase algorithms for the appropriate mavacamten dosing and monitoring schedule.
Discontinue treatment if LVEF drops below 50% during mavacamten administration. Follow the treatment discontinuation algorithm for guidance on interrupting, restarting, or permanently discontinuing mavacamten. If treatment is interrupted at the 2.5 mg dose, therapy may be restarted at 2.5 mg or permanently discontinued.
At Week 4: Assess Valsalva LVOT gradient.
If gradient is below 20 mmHg: Down-titrate to 2.5 mg once daily.
If gradient is 20 mmHg or higher: Maintain 5 mg once daily.
At Week 8: Reassess Valsalva LVOT gradient.
If gradient is below 20 mmHg: Down-titrate to 2.5 mg once daily.
If gradient is 20 mmHg or higher: Maintain 5 mg once daily.
At Week 12: Proceed to the maintenance phase if no dose adjustment has been made previously.
At any clinic visit:
If LVEF is below 50%: Interrupt treatment.
If LVEF returns to 50% or higher within 4 weeks after interruption: Restart treatment.
If the previous dose was 2.5 mg: Restart at 2.5 mg once daily.
If the previous dose was 5 mg, 10 mg, or 15 mg: Restart at the next lower daily dose level (e.g., 5 mg to 2.5 mg; 10 mg to 5 mg; 15 mg to 10 mg).
Reassess clinical status and perform echocardiogram at 4 weeks after restarting, and maintain the same dose for the subsequent 8 weeks unless LVEF drops below 50%.
For patients initiating mavacamten while on stable therapy with moderate CYP2C19 inhibitors or strong CYP3A4 inhibitors, refer to Section 2.2 for dosing instructions.
Assessments are performed at Week 12 and subsequent clinic visits.
If LVEF is below 50%: Interrupt treatment.
If LVEF is between 50% and 55% (exclusive): Maintain the same dose and follow up in 3 months.
If LVEF is 55% or higher and Valsalva LVOT gradient is below 30 mmHg: Maintain the same dose.
During the first 6-month cycle: Assess clinical status at 3 months, and reassess clinical status plus perform echocardiogram at 6 months.
Thereafter: Reassess clinical status and perform echocardiogram every 6 months.
If LVEF is 55% or higher and Valsalva LVOT gradient is 30 mmHg or higher: Up-titrate to the next higher daily dose level (e.g., 2.5 mg to 5 mg; 5 mg to 10 mg; 10 mg to 15 mg once daily).
Reassess clinical status and perform echocardiogram at 4 weeks, and maintain the same dose for the subsequent 8 weeks unless LVEF drops below 50%.
Further dose escalation is permitted after 12 weeks of treatment at the same dose level.
For patients with a normal or near-normal Valsalva LVOT gradient (approximately 30 mmHg) prior to mavacamten initiation: If LVEF is ≥55% and post-exercise LVOT gradient is ≥30 mmHg with persistent symptoms, the dose may be increased to the next higher daily dose level.
If LVEF is below 50%:
Interrupt treatment.
Recheck echocardiographic parameters every 4 weeks until LVEF returns to ≥50%.
If LVEF drops below 50% twice at the 2.5 mg daily dose: Permanently discontinue treatment.
If LVEF returns to 50% or higher:
Restart treatment at the next lower daily dose level (e.g., 5 mg to 2.5 mg; 10 mg to 5 mg; 15 mg to 10 mg). If treatment was interrupted at 2.5 mg, restart at 2.5 mg once daily.
Reassess clinical status and perform echocardiogram at 4 weeks after restarting, and maintain the same dose for the subsequent 8 weeks unless LVEF drops below 50%.
Follow the Maintenance Phase Algorithm.
Delay dose escalation in the presence of intercurrent illnesses that may impair systolic function (e.g., severe infection) or arrhythmias (e.g., atrial fibrillation or other uncontrolled tachyarrhythmias). For patients with intercurrent illnesses, consider interrupting mavacamten treatment.
If a dose is missed, take the missed dose as soon as possible. The next scheduled dose should be taken at the usual time on the following day. The exact timing of daily administration is not critical; do not take two doses on the same day.
Swallow the capsules whole. Do not break, open, or chew the capsules.
For patients on stable therapy with weak CYP2C19 inhibitors or moderate CYP3A4 inhibitors: Initiate mavacamten at the recommended starting dose of 5 mg orally once daily.
For patients on stable therapy with moderate CYP2C19 inhibitors or strong CYP3A4 inhibitors: Initiate mavacamten at a starting dose of 2.5 mg orally once daily.
If Valsalva LVOT gradient is below 20 mmHg at Week 4 or Week 8: Interrupt mavacamten treatment.
If LVEF returns to ≥50% after 4 weeks: Treatment may be resumed at 2.5 mg once daily.
If treatment is resumed at Week 12: Reassess clinical status, Valsalva LVOT gradient, and LVEF at 4 weeks, and maintain the current dose for the subsequent 8 weeks unless LVEF drops below 50%.
For patients starting weak to moderate CYP2C19 inhibitors or moderate to strong CYP3A4 inhibitors during mavacamten therapy: Down-titrate mavacamten to the next lower daily dose level (i.e., 15 mg to 10 mg; 10 mg to 5 mg; or 5 mg to 2.5 mg).
Schedule clinical and echocardiographic assessments at 4 weeks after initiating the inhibitor.
Do not up-titrate mavacamten to the next higher dose level within 12 weeks of starting the inhibitor.
Avoid initiating concomitant weak to moderate CYP2C19 inhibitors and moderate to strong CYP3A4 inhibitors in patients on stable 2.5 mg daily mavacamten, as no lower dose is available.
For short-term use (e.g., 1 week) of weak to moderate CYP2C19 inhibitors or moderate to strong CYP3A4 inhibitors: Interrupt mavacamten treatment during the course of inhibitor therapy. Mavacamten may be restarted immediately at the previous dose upon discontinuation of the concomitant inhibitor.
FDA，2025.04
Lucius Pharmaceuticals (Lao) LTD. (Lucius Pharmaceuticals), with its manufacturing campus in Laos located in the capital city of Vientiane in 2020, officially begins its great journey to make effective and affordable medicines available to people in need around the world...More
Lucius Pharmaceutical Co., Ltd., was established in 2020 in Vientiane, the capital of Laos. It aims to offer safe, effective, and affordable medicines globally. With a factory spanning 25,000 square meters, the company manufactures 200+ generic drugs in diverse therapeutic fields.
Address:No.26 Thongmang village, Xaythany district, Vientiane Capital, Laos
E-mail:laoslucius@gmail.com
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