Mavacamten
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Edzel Lorraine Co, DMD, MD[2]
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Black Box Warning
|
WARNING: RISK OF HEART FAILURE
See full prescribing information for complete Boxed Warning.
CAMZYOS can cause heart failure due to systolic dysfunction.
• Echocardiogram assessments of left ventricular ejection fraction (LVEF) required before and during CAMZYOS use. • Initiation in patients with LVEF <55% not recommended. Interrupt if LVEF <50% or if worsening clinical status. • Certain CYP450 inhibitors and inducers are contraindicated in patients taking CAMZYOS because of an increased risk of heart failure. • CAMZYOS is available only through a restricted program called the CAMZYOS REMS Program. |
Overview
Mavacamten is a cardiac myosin inhibitor that is FDA approved 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. There is a Black Box Warning for this drug as shown here. Common adverse reactions include dizziness (27%) and syncope (6%).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Mavacamten FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Mavacamten FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Mavacamten Contraindications in the drug label.
Warnings
|
WARNING: RISK OF HEART FAILURE
See full prescribing information for complete Boxed Warning.
CAMZYOS can cause heart failure due to systolic dysfunction.
• Echocardiogram assessments of left ventricular ejection fraction (LVEF) required before and during CAMZYOS use. • Initiation in patients with LVEF <55% not recommended. Interrupt if LVEF <50% or if worsening clinical status. • Certain CYP450 inhibitors and inducers are contraindicated in patients taking CAMZYOS because of an increased risk of heart failure. • CAMZYOS is available only through a restricted program called the CAMZYOS REMS Program. |
There is limited information regarding Mavacamten Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Mavacamten Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Mavacamten Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Mavacamten Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Mavacamten in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mavacamten in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Mavacamten during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Mavacamten in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Mavacamten in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Mavacamten in geriatric settings.
Gender
There is no FDA guidance on the use of Mavacamten with respect to specific gender populations.
Race
There is no FDA guidance on the use of Mavacamten with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Mavacamten in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Mavacamten in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Mavacamten in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Mavacamten in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Mavacamten Administration in the drug label.
Monitoring
There is limited information regarding Mavacamten Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Mavacamten and IV administrations.
Overdosage
There is limited information regarding Mavacamten overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Mavacamten Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Mavacamten Mechanism of Action in the drug label.
Structure
There is limited information regarding Mavacamten Structure in the drug label.
Pharmacodynamics
There is limited information regarding Mavacamten Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Mavacamten Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Mavacamten Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Mavacamten Clinical Studies in the drug label.
How Supplied
There is limited information regarding Mavacamten How Supplied in the drug label.
Storage
There is limited information regarding Mavacamten Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Mavacamten Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Mavacamten interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
CAMZYOS
Look-Alike Drug Names
There is limited information regarding Mavacamten Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.