For patients with NYHA class II-III obstructive HCM,

THE CAMZYOS® REMS PROGRAM: REAL-WORLD DATA FROM REAL PATIENTS ~3 YEARS POST-LAUNCH1,2

Data in this 34-month REMS capture were collected via a validated system from April 28, 2022 to February 27, 2025

REMS data capture every status form and every required echo

Explore this page:    |    Study Design     |    Valsalva LVOT Gradient     |    LVEF and/or HFH    |    Overview of Collected Data 

Echo=echocardiogram; HCM=hypertrophic cardiomyopathy; NYHA=New York Heart Association; REMS=Risk Evaluation and Mitigation Strategy.

REMS PROGRAM: Study Design

11,982 Patients on CAMZYOS in the REMS Data Capture at ~3 Years Post-Launch1

Background

The FDA approved CAMZYOS in April 2022 with a REMS program in collaboration with BMS to ensure monitoring for heart failure due to systolic dysfunction.

Methods

  • Not a clinical study – no required institutional review board approval
  • Data are based on submitted forms completed by HCPs and pharmacies and were focused on compliance with 4 key program elements:
    • HCP/pharmacy certifications and training
    • Patient enrollment and monitoring with echocardiograms
    • Screening for contraindicated concomitant medications and medications with drug interactions that require dosage adjustment
    • Ensuring that CAMZYOS dispensing occurred only when the previous 3 elements were completed and consistent with the REMS program

Patient composition

  • These outcomes are from REMS Assessment Reports provided to the FDA over a period of 34 months
  • The following are a summary of data from reports covering April 28, 2022 to February 27, 2025
    • 11,982 patients received at least 1 dispense of CAMZYOS
    • 11,007 patients had PSFs submitted as of February 27, 2025

Limitations

  • These single-arm data are not included in the US Full Prescribing Information for CAMZYOS; caution should be used in interpreting the data, as they were not statistically tested for significance but are descriptive in nature
  • REMS data collection is designed to demonstrate that the required safe use conditions have been met, and does not provide robust clinical data on safety, efficacy, or outcomes
  • Current data also do not provide exact values for various echocardiographic variables (eg, LVEF, Valsalva LVOT gradient), nor does it provide any information about potential confounding etiologies
  • The REMS program relies on individual providers making an accurate diagnosis of obstructive HCM prior to initiating CAMZYOS AND potential for underreporting exists
  • There is a potential for underreporting
    • It is possible that not all PSFs were submitted, and it is possible these patients experienced an unrelated decrease in LVEF, experienced an adverse event, potentially had insurance coverage issues, etc
    • The REMS program is designed to ensure that patients are eligible to continue therapy, and there is little incentive to report events that do not permit continued treatment with CAMZYOS

These data reflect CAMZYOS’ real-world clinical experience in the largest published data set

FDA=US Food and Drug Administration; HCP=healthcare professional; LVEF=left ventricular ejection fraction; LVOT=left ventricular outflow tract; PSF=patient status form; RWE=real-world evidence. 

REMS PROGRAM: Valsalva LVOT Gradient

Changes in Obstruction (Valsalva LVOT Gradient <30 mmHg) Observed in Real-World Patients Taking CAMZYOS1

Changes in Obstruction (Valsalva LVOT Gradient <30 mmHg) Observed in Real-World Patients Taking CAMZYOS, Chart

REMS data collection is designed to assess that the required safe use conditions have been met and does not provide robust clinical data on safety, efficacy, or outcomes. Provider discretion is advised. Results are not powered for significance.

Reductions in Valsalva LVOT gradient were sustained over time;
85% (n=72/85) did not have obstruction† at data cutoff (32 months)*

Valsalva LVOT gradient reported on the most recent PSF prior to the monthly dispense noted.
*Data for Months 33–34 are not shown due to low sample size.
†Defined as a peak Valsalva LVOT gradient of <30 mmHg. 

REMS PROGRAM: LVEF and/or HFH (heart failure hospitalization)

Rates of LVEF <50% and/or HFH Observed in Real-World Patients Taking CAMZYOS1

Rates of LVEF <50% and/or HFH Observed in Real-World Patients Taking CAMZYOS, Chart

REMS data collection is designed to assess that the required safe use conditions have been met and does not provide robust clinical data on safety, efficacy, or outcomes. Provider discretion is advised. Results are not powered for significance.

*Reported both on the same PSF.
HFH=heart failure hospitalization; PSF=patient status form. 

REMS PROGRAM: Overview of Collected DDI and Counseling Checklist Data*†1

147,306 drug interaction and counseling checklists were completed

REMS DDI Checklists Graphic

0.1% (78) checklists identified a contraindicated medication

  • The contraindicated medication was discontinued in all cases before CAMZYOS was dispensed

0.2% (367) checklists identified a concurrent medication that would require a dose adjustment

  • In 213 patients, the dose of CAMZYOS was reduced
  • In 1 patient, CAMZYOS was discontinued
  • In 153 patients, the other medication was discontinued

REMS data collection is designed to assess that the required safe use conditions have been met and does not provide robust clinical data on safety, efficacy, or outcomes. Provider discretion is advised. Results are not powered for significance.

*Reporting period was from April 28, 2022 to February 27, 2025.
†A checklist must be completed and submitted to the REMS prior to every dispense. Not every completed checklist results in a dispense.
DDI=drug-drug interaction. 

References:

  1. Desai MY, Massera D, Seto D, et al. Mavacamten: real-world experience from 34 months of Risk Evaluation and Mitigation Strategy (REMS) program. Presented at the American Heart Association Scientific Sessions. November 8-9, 2025. Poster MP1039.
  2. CAMZYOS [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2025.
References

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEART FAILURE

CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following:

 
  • Strong CYP2C19 inhibitors
  • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CAMZYOS REMS Program.

CONTRAINDICATIONS

CAMZYOS is contraindicated with concomitant use of:

 
  • Strong CYP2C19 inhibitors
  • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

WARNINGS AND PRECAUTIONS

Heart Failure
CAMZYOS reduces systolic contraction and can cause heart failure or significantly reduce ventricular function. Patients who experience a serious intercurrent illness (eg, serious infection) or arrhythmia (eg, atrial fibrillation or other uncontrolled tachyarrhythmia) are at greater risk of developing systolic dysfunction and heart failure.

Assess the patient’s clinical status and LVEF prior to and regularly during treatment and adjust the CAMZYOS dose accordingly. 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.

Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.

CYP450 Drug Interactions Leading to Heart Failure or Loss of Effectiveness

CAMZYOS is primarily metabolized by CYP2C19 and CYP3A4 enzymes. Concomitant use of CAMZYOS and drugs that interact with these enzymes may lead to life-threatening drug interactions such as heart failure or loss of effectiveness.

Advise patients of the potential for drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). Advise patients to inform their healthcare provider of all concomitant products prior to and during CAMZYOS treatment.

CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program

CAMZYOS is only available through a restricted program called the CAMZYOS REMS Program because of the risk of heart failure due to systolic dysfunction. Notable requirements of the CAMZYOS REMS Program include the following:

 
  • Prescribers must be certified by enrolling in the REMS Program
  • Patients must enroll in the REMS Program and comply with ongoing monitoring requirements
  • Pharmacies must be certified by enrolling in the REMS Program and must only dispense to patients who are authorized to receive CAMZYOS
  • Wholesalers and distributors must only distribute to certified pharmacies

Further information is available at  www.CAMZYOSREMS.com  or by telephone at  1-833-628-7367.

Embryo-Fetal Toxicity

CAMZYOS may cause fetal toxicity when administered to a pregnant female, based on animal studies. Confirm absence of pregnancy in females of reproductive potential prior to treatment and advise patients to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. Combined hormonal contraceptives (CHCs) containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other CHCs. If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS.

ADVERSE REACTIONS

In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%). There were no new adverse reactions identified in VALOR-HCM.

Effects on Systolic Function

In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.

DRUG INTERACTIONS

Potential for Other Drugs to Affect Plasma Concentrations of CAMZYOS

CAMZYOS is primarily metabolized by CYP2C19 and to a lesser extent by CYP3A4 and CYP2C9. Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect the exposures of CAMZYOS.

Impact of Other Drugs on CAMZYOS:

 
  • Strong CYP2C19 Inhibitors: Concomitant use increases CAMZYOS exposure, which may increase the risk of heart failure due to systolic dysfunction. Concomitant use is contraindicated
  • Moderate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers:  Concomitant use decreases CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. The risk of heart failure due to systolic dysfunction may increase with discontinuation of these inducers as the levels of induced enzyme normalizes. Concomitant use is contraindicated
  • Weak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors: Concomitant use with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Initiate CAMZYOS at the recommended starting dose of 5 mg orally once daily in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (ie, 15 to 10 mg, 10 to 5 mg, or 5 to 2.5 mg) in patients who are on CAMZYOS treatment and intend to initiate a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Schedule clinical and echocardiographic assessment 4 weeks after inhibitor initiation, and do not up-titrate CAMZYOS until 12 weeks after inhibitor initiation. Avoid initiation of concomitant weak CYP2C19 and moderate CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available. For short-term use (eg, 1 week), interrupt CAMZYOS for the duration of treatment with a weak inhibitor of CYP2C19 or a moderate inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy
  • Moderate CYP2C19 Inhibitors or Strong CYP3A4 Inhibitors: Concomitant use with a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Discontinuing use of a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor after long-term concomitant use may decrease CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. Initiate CAMZYOS at a starting dosage of 2.5 mg orally once daily in patients who are on a stable therapy with a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (ie, 15 to 10 mg, 10 to 5 mg, or 5 to 2.5 mg) in patients who are on CAMZYOS and intend to initiate a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Avoid initiation of concomitant moderate CYP2C19 and strong CYP3A4 inhibitors in patients who are on a stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available. An increase in dose of CAMZYOS may be needed if the moderate inhibitor of CYP2C19 or strong inhibitor of CYP3A4 is discontinued after long-term concomitant use. Monitor for new or worsening symptoms. For short-term use (ie, when CAMZYOS dose modification is not feasible), interrupt CAMZYOS for the duration of treatment with a moderate inhibitor of CYP2C19 or a strong inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy

Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs

CAMZYOS is an inducer of CYP3A4, CYP2C9, and CYP2C19. Concomitant use with CYP3A4, CYP2C9, or CYP2C19 substrates may reduce plasma concentration of these drugs. Closely monitor when CAMZYOS is used with concomitant CYP3A4, CYP2C9, or CYP2C19 substrates unless otherwise recommended in the Prescribing Information.

Certain Combined Hormonal Contraceptives (CHCs): Progestin and ethinyl estradiol are CYP3A4 substrates. Concomitant use of CAMZYOS may decrease exposures of certain progestins, which may lead to contraceptive failure. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS, but if other CHCs are used, advise patients to add nonhormonal contraception (such as condoms) or use an alternative contraceptive method that is not affected by CYP450 enzyme induction (eg, intrauterine system) during concomitant use and for 4 months after the last dose of CAMZYOS.

Drugs That Reduce Cardiac Contractility

Expect additive negative inotropic effects of CAMZYOS and other drugs that reduce cardiac contractility. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.

If concomitant therapy with a negative inotrope is initiated, or if the dose of a negative inotrope is increased, monitor LVEF closely until stable doses and clinical response have been achieved.

SPECIFIC POPULATIONS

Pregnancy

CAMZYOS may cause fetal harm when administered to a pregnant female. Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. There is a pregnancy safety study for CAMZYOS. If CAMZYOS is administered during pregnancy, or if a patient becomes pregnant while receiving CAMZYOS or within 4 months after the last dose of CAMZYOS, healthcare providers should report CAMZYOS exposure by contacting Bristol Myers Squibb at 1-800-721-5072 or www.bms.com.

Lactation

The presence of CAMZYOS in human or animal milk, the drug’s effects on the breastfed infant, or the effects on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CAMZYOS and any potential adverse effects on the breastfed child from CAMZYOS or from the underlying maternal condition.

Females and Males of Reproductive Potential

Confirm absence of pregnancy in females of reproductive potential prior to initiation of CAMZYOS. Advise females of reproductive potential to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other CHCs. If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) or use an alternative contraceptive method during concomitant use and for 4 months after the last dose of CAMZYOS.

INDICATION

CAMZYOS® (mavacamten) 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.

Please see US  Full Prescribing Information, including  Boxed WARNING.

3500-US-2500761  01/26

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