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Safety

Safety of MYQORZO™

Adverse events

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Effects on blood pressure

In SEQUOIA-HCM, SBP ≥160 mmHg was observed in ≈16% of patients taking MYQORZO and 8% of patients taking placebo1

Increases in blood pressure in patients treated with MYQORZO are consistent with relief of LVOT obstruction and improved cardiac output1

Hypertension was the only adverse reaction occurring in >5% of patients and more commonly on MYQORZO than on placebo1

MYQORZO

8%

Placebo

2%

Any adverse event that led to discontinuation2

MYQORZO

0.7%

(n=1)

Placebo

1.4%

(n=2)

Systolic function

No treatment interruptions or clinical heart failure events were observed in patients with LVEF <50% taking MYQORZO in SEQUOIA-HCM1

Incidence of LVEF <50%1*

During the 24-week treatment period, 4% (n=5) of patients treated with MYQORZO and 1% (n=1) of patients treated with placebo experienced LVEF <50%1

Median LVEF was 47% for these 5 patients treated with MYQORZO (range, 34% to 49%)1

5-mg arrow

Occurrences of LVEF <50% with MYQORZO were asymptomatic and reversible upon down-titration by 5 mg1,3

Effect of treatment on LVEF measurements2

Treatment with MYQORZO resulted in a

-4.8%

mean LVEF difference vs placebo at Week 24

LS mean difference vs placebo: (95% CI, -6.3 to -3.2)

  • Mean baseline (SD) LVEF was 75% (6) in both treatment groups1
  • Four weeks after the end of treatment, mean LVEF was similar between both treatment groups (LVEF LS mean difference: -0.8%)1,3

MYQORZO reduces LVEF and can cause heart failure due to systolic dysfunction. Please see the Boxed WARNING in the Important Safety Information below to learn about the risk for heart failure.1

DRUG-DRUG INTERACTIONS

MYQORZO is metabolized via multiple CYP450 pathways, leading to a well-characterized understanding of potential drug-drug interactions1

MYQORZO is contraindicated with concomitant use of rifampin1

Pharmacokinetic considerations for MYQORZO1

CYP enzymes

Concomitant administration of drugs that inhibit multiple P450 pathways of MYQORZO elimination, strong inhibitors of CYP2C9, and moderate-to-strong inducers of CYP3A may affect the exposure of MYQORZO.

special populations

In patients with mild-to-moderate hepatic impairment, no clinically meaningful differences in the pharmacokinetics of MYQORZO were observed.

Additional information

There are no available data on the use of MYQORZO during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Clinical trial results for MYQORZO

Discover the data

Learn more about treating your patients with MYQORZO

Starting and staying on treatment

*All echocardiograms were sent to the core laboratory for interpretation and statistical analyses. On-site interpretations of LVEF and LVOT gradient were used for dose titration and clinical safety decisions, and were interpreted by a cardiologist at the investigational site.2

CI=confidence interval; CYP=cytochrome; LS=least squares; LVEF=left ventricular ejection fraction; LVOT=left ventricular outflow tract; SBP=systolic blood pressure; SD=standard deviation.

References: 1. MYQORZO (aficamten). Prescribing information. Cytokinetics; 2025. 2. Maron MS, Masri A, Nassif ME, et al. Aficamten for symptomatic obstructive hypertrophic cardiomyopathy. N Engl J Med. 2024;390(20):1849-1861. doi:10.1056/NEJMoa2401424 3. Coats CJ, Masri A, Nassif ME, et al. Dosing and safety profile of aficamten in symptomatic obstructive hypertrophic cardiomyopathy: results from SEQUOIA-HCM. J Am Heart Assoc. 2024;13(15):e035993. doi:10.1161/JAHA.124.035993

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEART FAILURE

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

Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients with LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF is <50% and ≥40%. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction.

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

CONTRAINDICATIONS

MYQORZO is contraindicated with concomitant use of rifampin.

WARNING AND PRECAUTIONS

Heart Failure
MYQORZO reduces cardiac contractility, which can reduce LVEF and cause heart failure.

Patients who experience a serious intercurrent illness (eg, serious infection) or arrhythmia (eg, new or uncontrolled atrial fibrillation) may be at greater risk of developing systolic dysfunction and heart failure.

Assess patients’ clinical status and LVEF prior to and during treatment and adjust the MYQORZO dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide may be signs and symptoms of heart failure.

Initiation of MYQORZO in patients with LVEF <55% is not recommended.

MYQORZO REMS Program

MYQORZO is available only through a restricted program called the MYQORZO REMS Program, because of the risk of heart failure due to systolic dysfunction.

Notable requirements of the MYQORZO REMS Program include:

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

Further information is available at www.MYQORZOREMS.com, or at 1-844-285-7367.

Cytochrome P450 Interactions Leading to Heart Failure or Loss of Effectiveness
MYQORZO is metabolized primarily by CYP2C9, and to a lesser extent by CYP3A, CYP2D6, and CYP2C19 enzymes. Initiation of medications that inhibit multiple P450 pathways of MYQORZO elimination (eg, fluconazole, voriconazole, or fluvoxamine) or strong CYP2C9 inhibitors, and discontinuation of moderate-to-strong CYP3A inducers may lead to increased blood concentrations of aficamten and increase the risk of heart failure due to systolic dysfunction. Conversely, initiation of medications that induce P450 pathways of MYQORZO (eg, rifampin, moderate-to-strong CYP3A inducers) may lead to decreased blood concentrations of aficamten and potential loss of effectiveness. Assess LVEF 2 to 8 weeks after initiation of such inhibitors or after discontinuation of such inducers and adjust the dose of MYQORZO accordingly.

Advise patients of the potential for drug interactions. Advise patients to inform their healthcare provider of all concomitant medications prior to and during MYQORZO treatment.

ADVERSE REACTIONS

Hypertension (8% vs 2%) was the only adverse reaction occurring in >5% of patients and more commonly on MYQORZO than on placebo in the pivotal trial.

INDICATIONS AND USAGE

MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

Please see full Prescribing Information, including Boxed WARNING.