Is Mavacamten approved by the FDA?

Mavacamten received its first approval on 28 April 2022 in the USA for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive HCM to improve functional capacity and symptoms and is under evaluation in the EU for the treatment of obstructive HCM.

Dosage Forms and Administration

The medication is available in oral capsule forms of 10 mg, 15 mg, 2.5 mg, and 5 mg. It is essential to follow the prescribed dosage regimen strictly as directed by healthcare providers. Typically, mavacamten is administered once daily.

How Mavacamten Works

Mavacamten functions by improving symptoms related to obstructive HCM, aiming to enhance functional capacity and alleviate associated symptoms.

Special Considerations and Warnings

• Side Effects: Common side effects of mavacamten include dizziness and fainting. It's crucial to seek immediate medical attention if more severe symptoms such as heart failure symptoms (e.g., shortness of breath, chest pain, rapid weight gain) occur.
• Warnings: Mavacamten usage requires careful monitoring due to its potential to cause heart failure, especially when combined with certain medications used for infections, asthma, or other heart conditions.
• Pregnancy and Breastfeeding: Mavacamten may harm unborn babies, so effective birth control measures should be taken during treatment. It is not recommended for breastfeeding mothers.

Dosing and Administration

• Initial Dose: Typically, treatment begins with a 5 mg oral dose once daily.
• Titration: Depending on individual response and tolerance, subsequent doses can range from 2.5 mg to a maximum of 15 mg daily. Adjustments are based on clinical assessment and specific cardiac parameters like left ventricular ejection fraction (LVEF) and Valsalva left ventricular outflow tract (LVOT) gradient.

Drug Interactions

Mavacamten may interact with a variety of medications, including certain antibiotics, antifungal agents, and medications used to treat HIV or hepatitis C. It's crucial to inform healthcare providers about all medications being taken to prevent potentially harmful interactions.

Conclusion

In conclusion, mavacamten, available as Camzyos, is an FDA-approved medication for adults with obstructive hypertrophic cardiomyopathy. It aims to improve symptoms and functional capacity, although it requires careful monitoring due to its potential side effects and interactions with other drugs. Patients should follow their prescribed regimen closely and report any concerning symptoms promptly to their healthcare provider.

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