Mavacamten

Mavacamten is an allosteric and reversible inhibitor selective for cardiac myosin. Mavacamten modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation.

• CAMZYOS ® 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. CAMZYOS 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.

• CAMZYOS is contraindicated with concomitant use of: • Strong CYP2C19 inhibitors [see Warnings and Precautions (5.2) , Drug Interactions (7.1) ] • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers [see Warnings and Precautions (5.2) , Drug Interactions (7.1) ] • Strong CYP2C19 inhibitors. ( 4 , 5.2 ) • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.contraindicated

Dosage must be individualized based on clinical status and echocardiographic assessment of patient response. Refer to the Full Prescribing Information for instructions. ( 2.1 ) 2.1 Initiation, Maintenance, and Interruption of Treatment Confirm absence of pregnancy and usage of effective contraception in females of reproductive potential [see Warnings and Precautions (5.4) ] . Initiation or up-titration of CAMZYOS in patients with LVEF <55% is not recommended. The recommended starting dose is 5 mg orally once daily without regard to food; allowable subsequent doses with titration are 2.5 mg, 5 mg, 10 mg, or 15 mg orally once daily. The maximum recommended dose is 15 mg orally once daily. Patients may develop heart failure while taking CAMZYOS. Regular LVEF and Valsalva left ventricular outflow tract (LVOT) gradient assessment is required for careful titration to achieve an appropriate target Valsalva LVOT gradient, while maintaining LVEF ≥50% and avoiding heart failure symptoms (see Figure 1 and Figure 2). Daily dosing takes weeks to reach steady-state drug levels and therapeutic effects, and genetic variation in metabolism and drug interactions can cause large differences in exposure [see Boxed Warning , Contraindications (4) , Warnings and Precautions (5.2) , Drug Interactions (7.1) and Clinical Pharmacology (12.3) ] . When initiating or titrating CAMZYOS, first consider LVEF then consider the Valsalva LVOT gradient and patient clinical status to guide appropriate CAMZYOS dosing.

• Heart Failure : Consider interruption of CAMZYOS in patients with intercurrent illness. ( 2.1 , 5.1 ) • Drug Interactions Leading to Heart Failure or Loss of Effectiveness : Advise patients of the potential for drug interactions including with over-the-counter medications. ( 4 , 5.2 , 17 ) • Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential to use effective contraception until 4 months after the last dose. Avoid concomitant use with a combined hormonal contraceptive that contains a progestin other than norethindrone. ( 5.4 , 7.2 , 8.1 , 8.3 ) 5.1 Heart Failure CAMZYOS reduces systolic contraction and can cause heart failure or significantly reduce ventricular function. Patients who experience a serious intercurrent illness (e.g., serious infection) or arrhythmia (e.g., atrial fibrillation or other uncontrolled tachyarrhythmia) are at greater risk of developing systolic dysfunction and heart failure [see Clinical Trial Experience (6.1) ] . Assess the patient’s clinical status and LVEF prior to and regularly during treatment and adjust the CAMZYOS dose accordingly [see Dosage and Administration (2.1) ] . New or worsening arrhythmia, 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 [see Dosage and Administration (2.1 , 2.2 )] .

The following adverse reaction is discussed in other sections of the labeling: • Heart failure [see Warnings and Precautions (5.1) ] Adverse reactions occurring in >5% of patients and more commonly on CAMZYOS than on placebo were dizziness (27%) and syncope (6%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CAMZYOS was evaluated in EXPLORER-HCM, a Phase 3, double-blind, randomized, placebo-controlled trial [see Clinical Studies (14) ] . Of the 251 adults with obstructive HCM, 123 patients were treated with CAMZYOS 2.5-15 mg daily and 128 were treated with placebo. CAMZYOS-treated patients had a median duration of exposure of 30 weeks (range: 2-40 weeks). Syncope (0.8%) was the only adverse drug reaction leading to discontinuation in patients receiving CAMZYOS. Adverse reactions occurring in >5% of patients and more commonly on CAMZYOS than on placebo were dizziness (27% vs. 18%) and syncope (6% vs. 2%). The safety of CAMZYOS in patients was further evaluated in VALOR-HCM, a Phase 3, double-blind, randomized, placebo-controlled trial [see Clinical Studies (14) ] .

8.1 Pregnancy Risk Summary Based on animal data, CAMZYOS may cause fetal harm when administered to a pregnant female. There are no human data on the use of CAMZYOS during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. The underlying maternal condition during pregnancy poses a risk to the mother and fetus (see Clinical Considerations ) . Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. In animal embryo-fetal development studies, mavacamten-related decreases in mean fetal body weight, reductions in fetal ossification of bones, and increases in post-implantation loss (early and/or late resorptions) were observed in rats and increases in visceral and skeletal malformations were observed in both rabbits and rats at dose exposures similar to that achieved at the maximum recommended human dose (MRHD) (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There is a pregnancy safety study for CAMZYOS.

Metabolism

Mavacamten exposure increases dose proportionally following multiple once-daily doses of 1 mg to 15 mg. At the same dose level of CAMZYOS, 170% higher exposures of mavacamten are observed in patients with HCM compared to healthy subjects.

Clinical Experience and Effects • Cardiovascular effects may include reduced LVEF (left ventricular ejection fraction), heart failure, hypotension, and asystole refractory to medical intervention. • Neurological effects may include dizziness and syncope. • An infant death was reported after accidental ingestion of three 15 mg capsules (45 mg). • An adult administered a single dose of 144 mg developed a vasovagal reaction, hypotension, and asystole, but the subject recovered. Management • Discontinue CAMZYOS treatment. • Provide medically supportive measures to maintain hemodynamic stability and monitor left ventricular function. • Consider administering activated charcoal (pediatric dose is 1 g/kg; adult dose is 50 g) within 2 hours of ingestion in addition to other supportive measures. The benefit of activated charcoal is negligible after 6 hours [see Clinical Pharmacology (12.3) ]. • Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

• Apr 28, 2022NDANDA214998Bristol

1. 1Product Dose Omission Issue2896.7%
2. 2Fatigue2886.7%
3. 3Dyspnoea2796.5%
4. 4Atrial Fibrillation2746.4%
5. 5Dizziness2646.2%
6. 6Product Use Issue2124.9%
7. 7Off Label Use1643.8%
8. 8Ejection Fraction Decreased1483.5%
9. 9Headache1353.2%
10. 10Nasopharyngitis1333.1%
11. 11Palpitations1273.0%
12. 12Chest Pain1222.8%
13. 13Adverse Event1162.7%
14. 14Weight Increased1022.4%
15. 15Therapy Interrupted1002.3%

The 10 most recently updated of 43 ClinicalTrials.gov registrations naming Mavacamten as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada
  Completed · Observational · 683 enrolled · Bristol-Myers Squibb
  NCT06549608updated 2026-06-12
• A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive-HCM)
  Recruiting · Observational · 1,700 enrolled · Bristol-Myers Squibb
  NCT05489705updated 2026-06-12
• Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
  Recruiting · Interventional · 75 enrolled · University of Manchester
  NCT07120776updated 2026-05-22
• Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy
  Recruiting · Phase 4 · Interventional · 40 enrolled · Oregon Health and Science University
  NCT07600177updated 2026-05-20
• A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
  Recruiting · Observational · 500 enrolled · Bristol-Myers Squibb
  NCT07361289updated 2026-05-11
• COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
  Active not recruiting · Observational · 331 enrolled · Bristol-Myers Squibb
  NCT06372457updated 2026-05-04
• Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US
  Recruiting · Observational · 362 enrolled · Bristol-Myers Squibb
  NCT07557498updated 2026-04-29
• A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)
  Active not recruiting · Phase 4 · Interventional · 50 enrolled · Bristol-Myers Squibb
  NCT07004972updated 2026-04-28
• Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)
  Recruiting · Observational · 36 enrolled · Bristol-Myers Squibb
  NCT07541833updated 2026-04-21
• Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy
  Completed · Observational · 222 enrolled · Chinese Academy of Medical Sciences, Fuwai Hospital
  NCT07529938updated 2026-04-17

Frequently asked questions

How does Mavacamten work?

Mavacamten is an allosteric and reversible inhibitor selective for cardiac myosin. Mavacamten modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation.

What is Mavacamten used for?

According to FDA labeling, Mavacamten carries indications including: CAMZYOS ® 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. CAMZYOS 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Mavacamten?

Mavacamten is classified as Other cardiac preparations, Cardiac Myosin Inhibitor, Cardiac Myosin Inhibitors, Cytochrome P450 2C19 Inducers, Cytochrome P450 2C19 Inhibitors, Cytochrome P450 3A4 Inducers, Cytochrome P450 3A4 Inhibitors.

What are the brand names for Mavacamten?

Mavacamten is marketed under brand names including Camzyos.

What are the contraindications for Mavacamten?

Mavacamten labeling lists contraindications including: CAMZYOS is contraindicated with concomitant use of: • Strong CYP2C19 inhibitors [see Warnings and Precautions (5.2) , Drug Interactions (7.1) ] • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers [see Warnings and Precautions (5.2) , Drug Interactions (7.1) ] • Strong CYP2C19 inhibitors. ( 4 , 5.2 ) • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.. Always consult the full prescribing information and a clinician.