MYQORZO 15 mg/1
AFICAMTEN · TABLET, FILM COATED · Cytokinetics Inc.
Aficamten is an oral prescription medication used to treat symptomatic obstructive hypertrophic cardiomyopathy, a heart condition where the heart muscle becomes thickened and obstructs blood flow. It works by reducing the force of heart contractions to help improve symptoms and exercise ability in patients with this condition.
Key Facts
- Brand Name
- MYQORZO
- Generic Name
- AFICAMTEN
- NDC Code (Product)
82112-115- Manufacturer
- Cytokinetics Inc.
- Strength
- 15 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA219083
- Marketing Start
- 01/12/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. MYQORZO is a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended starting dose is 5 mg orally once daily. ( 2.1 ) Dosage is individualized based on echocardiographic assessments and clinical status. Refer to Full Prescribing Information for instructions on dosage modification. ( 2.1 , 2.2 ) 2.1 Evaluation Before and During Use of MYQORZO Initiation or up-titration of MYQORZO in patients with LVEF <55% is not recommended. Patients may develop heart failure while taking MYQORZO. Regular LVEF and Valsalva left ventricular outflow tract gradient (LVOT-G) assessment is needed for titration to achieve an appropriate target Valsalva LVOT-G, while maintaining LVEF ≥50% and avoiding heart failure symptoms. 2.2 Recommended Dosage and Administration The recommended starting dose of MYQORZO is 5 mg orally once daily. Increase the dose every 2 to 8 weeks by 5 mg until a maintenance dose or the maximum recommended dose of 20 mg once daily is achieved. The maintenance dose of MYQORZO is individualized based on the patient's LVEF and LVOT-G. Recommendations for dosing based on LVEF and LVOT-G criteria are provided in Table 1. Table 1: Dose Adjustment of MYQORZO LVEF Valsalva LVOT-G Dose Adjustment ≥55% ≥30 mmHg Increase d…
Contraindications
4 CONTRAINDICATIONS MYQORZO is contraindicated with concomitant use of rifampin [see Warnings and Precautions (5.3) and Drug Interactions (7.1) ] . Rifampin ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Drugs that inhibit multiple pathways of MYQORZO elimination, strong CYP2C9 inhibitors, or moderate-to-strong CYP3A inducers may increase risk of heart failure. MYQORZO dose reduction and additional monitoring may be required when initiating or discontinuing these drugs. ( 2.3 , 7.1 ) 7.1. Potential for Other Drugs to Affect Plasma Concentrations of MYQORZO Aficamten is primarily metabolized by CYP2C9 and, to a lesser extent by CYP3A, CYP2D6, and CYP2C19. Concomitant administration of drugs that inhibit multiple P450 pathways of aficamten elimination, strong inhibitors of CYP2C9, and moderate-to-strong inducers of CYP3A, may affect the exposure of aficamten [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ] (see Table 2 ). Table 2: Established and Potentially Significant Pharmacokinetic Drug-Drug Interactions with MYQORZO Inhibitors of Multiple CYPs Fluvoxamine Clinical Impact Fluvoxamine is a strong CYP2C19 inhibitor, weak to moderate CYP3A inhibitor, weak CYP2C9 inhibitor, and weak CYP2D6 inhibitor. Coadministration of fluvoxamine is predicted to increase aficamten exposure, which may increase the risk of developing heart failure due to syst…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reaction is discussed in other sections of labeling: Heart Failure [see Warnings and Precautions (5.1) ] The most common adverse reaction was hypertension (8%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cytokinetics at 1-833-633-2986 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 MYQORZO was evaluated in SEQUOIA-HCM, a phase 3, randomized, double-blind, placebo-controlled study [see Clinical Studies (14) ] . Of the 282 adults with oHCM, 142 patients received daily doses of MYQORZO (initiated at 5 mg and titrated up to a maximum dose of 20 mg) and 140 patients received placebo. The median treatment duration for patients receiving MYQORZO was ~24 weeks (range 4 to 29 weeks). Hypertension (8% vs. 2%) was the only adverse reaction occurring in >5% of patients and more commonly on MYQORZO than on placebo. Eligible oHCM patient…
Frequently Asked Questions
What is MYQORZO used for?
Aficamten is an oral prescription medication used to treat symptomatic obstructive hypertrophic cardiomyopathy, a heart condition where the heart muscle becomes thickened and obstructs blood flow. It works by reducing the force of heart contractions to help improve symptoms and exercise ability in patients with this condition.
Is MYQORZO a controlled substance?
MYQORZO is not classified as a controlled substance by the DEA.
What is the generic name for MYQORZO?
The generic name for MYQORZO is AFICAMTEN. There are no other listed brand versions of AFICAMTEN.
What is the NDC code for MYQORZO 15 mg/1?
The NDC (National Drug Code) for MYQORZO 15 mg/1 is 82112-115, listed by Cytokinetics Inc..
Other MYQORZO Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)