Camzyos

About Mavacamten(Camzyos)

• Camzyos received Food and Drug Administration (FDA) approval on June 15, 2023, which belongs to the class of drugs known as Cardiac Myosin Inhibitors.
• Mavacamten, available under the brand name Camzyos, is a medication designed for the treatment of obstructive hypertrophic cardiomyopathy. 
• Indicated for adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM), Camzyos aims to enhance functional capacity and alleviate symptoms.
• Mavacamten, an allosteric and reversible inhibitor targeting cardiac myosin, crucially modulates myosin heads entering “on actin” states. 
• This reduces the likelihood of force-producing (systolic) and residual (diastolic) cross-bridge formation, addressing characteristic features of obstructive hypertrophic cardiomyopathy. 
• By shifting the myosin population towards an energy-saving super-relaxed state, Mavacamten effectively addresses mechanistic hallmarks of HCM. In patients with hypertrophic cardiomyopathy, it demonstrates reduced dynamic left ventricular outflow tract (LVOT) obstruction and improved cardiac filling pressures.
• Hypertrophic obstructive cardiomyopathy (HOCM), historically referred to as idiopathic hypertrophic subaortic stenosis, is a relatively common disorder characterized by the thickening of the heart muscle, particularly the wall (septum) between the two bottom chambers (ventricles). 
• This thickening can block or reduce blood flow from the left ventricle to the aorta, leading to symptoms such as rapid or irregular heartbeat, difficulty breathing, and chest pain

Strength: 

Camzyos capsule is available as 2.5 mg, 5 mg, 10 mg, and 15 mg. 

Recommended Dosage:

The dosage should be customized according to the patient’s clinical condition and the echocardiographic evaluation of their response. Delay Camzyos dose increases during intercurrent illness (e.g., severe infection) or an arrhythmia that may affect systolic function. Consider interrupting Camzyos in patients with such illnesses. Swallow capsules whole. Do not break, open, or chew the capsules. 

• The initial recommended dose is 5 mg once daily, regardless of food intake, with subsequent allowable titration doses of 2.5, 5, 10, or 15 mg once daily. 
• During the initiation phase at weeks 4, 8, and 12, dosing adjustments are made based on the Valsalva LVOT gradient and echocardiographic assessment. 
• In the maintenance phase starting at week 12, the dosage is adjusted according to the patient’s left ventricular ejection fraction (LVEF) and Valsalva LVOT gradient. 
• If LVEF is less than 50%, treatment is interrupted. For LVEF between 50-55% or LVEF ≥55% with a Valsalva LVOT gradient <30 mmHg, up-titration to the next higher daily dose level is considered, with clinical and echocardiographic reassessment after 4 weeks and maintenance at the same dose for the next 8 weeks unless LVEF is less than 50%. Further up-titration is allowed after 12 weeks of treatment at the same dose level.

Important:

It is crucial to consult your healthcare provider about your medical history and current medications, including details about smoking and alcohol consumption, before initiating Camzyos. Providing a comprehensive list of medications is essential to ensure a safe introduction of new drugs, and this information assists healthcare providers in making informed decisions tailored to individual patient needs.

Warnings & Precautions

• Camzyos carries the risk of heart failure due to systolic dysfunction, with echocardiogram assessments of left ventricular ejection fraction (LVEF) required before and during its use. 
• Initiation is not recommended in patients with LVEF <55%, and interruption is advised if LVEF falls below 50% or if worsening clinical status occurs. 
• Specific CYP450 inhibitors and inducers are contraindicated due to an increased risk of heart failure. 
• Consider interrupting Camzyos in patients with intercurrent illness, and inform patients about potential drug interactions, including those with over-the-counter medications, that may lead to heart failure or loss of effectiveness. 
• It is contraindicated in concomitant use with moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, as well as moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Common Camzyos Side Effects:

• Dizziness
• Fainting (syncope)

Use in Specific Population

• There is a lack of available data on the use of Camzyos in pregnant women, and its potential risks for adverse developmental outcomes are unknown. Hence, before starting the medicine, inform your doctor if you are pregnant or planning to get pregnant. 
• Additionally, Camzyos may cause embryo-fetal toxicity, necessitating the use of effective contraception by females of reproductive potential until 4 months after the last dose. 
• It is unknown whether Camzyos passes into the breastmilk. So, it is recommended to inform your healthcare provider if you are breastfeeding. 
• The safety and effectiveness of Camzyos have not been determined in pediatric patients under 18 years of age. 
• Additionally, there is no recommended dosage adjustment for patients with hepatic impairment.

Storage and Handling

• Ensure to maintain Camzyos within the temperature range of 68°F to 77°F (20°C to 25°C). 
• If the temperature briefly goes between 59°F and 86°F (15°C to 30°C), that’s acceptable. Always store it properly.
• It is recommended to keep the medicine away from direct light. 
• Do not freeze the medicine. 
• Keep the medicine away from pets and children.