Camzyos 10mg Capsules
WARNING: This drug may cause heart failure. You will need to have your heart function checked before you start this drug and while you take it. Call your doctor right away if you have signs of heart problems like new or worse cough or shortness of breath, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than 5 pounds in 24 hours, dizziness, or passing out.There are many other drugs that must not be taken with this drug. Doing so may raise the risk of heart failure and other side effects. Be sure your doctor and pharmacist know about all the drugs that you take. This includes prescription drugs; OTC drugs like omeprazole, esomeprazole, or cimetidine; natural products; and vitamins. @ COMMON USES: It is used to treat a heart problem called hypertrophic cardiomyopathy (HCM).
Drug Class
Cardiac Myosin Inhibitor
Pharmacologic Class
Selective cardiac myosin allosteric modulator
Pregnancy Category
Not available
FDA Approved
Apr 2022
DEA Schedule
Not Controlled
Overview
What is this medicine?
Camzyos is a medication used to treat a specific type of heart condition called obstructive hypertrophic cardiomyopathy (oHCM). In this condition, the heart muscle becomes too thick, making it harder for the heart to pump blood. Camzyos works by helping the heart muscle relax more, which allows blood to flow more easily out of the heart. It's important to take this medication exactly as prescribed and to have regular heart tests (echocardiograms) to make sure your heart is responding well and to monitor for side effects.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. Swallow the tablet whole - do not chew, open, or break it. Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses on the same day.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. Swallow the tablet whole - do not chew, open, or break it. Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses on the same day.
Lifestyle & Tips
- Adhere strictly to the prescribed dosing regimen.
- Attend all scheduled appointments for echocardiograms and clinical evaluations.
- Report any new or worsening symptoms of heart failure (e.g., shortness of breath, swelling, unusual fatigue) immediately to your doctor.
- Avoid grapefruit juice and St. John's Wort as they can interact with this medication.
- Inform all healthcare providers, including dentists and pharmacists, that you are taking mavacamten.
- Do not stop taking Camzyos without consulting your doctor, as this can worsen your condition.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 5 mg orally once daily. Dose adjusted based on LVEF and Valsalva LVOT gradient.
Dose Range:
2.5 - 15 mg
Condition-Specific Dosing:
obstructiveHypertrophicCardiomyopathy:
Initial dose 5 mg orally once daily. Maximum dose 15 mg once daily. Dosing guided by LVEF and Valsalva LVOT gradient. If LVEF <50%, interrupt treatment. If LVEF <30% or symptomatic heart failure, permanently discontinue. Dose adjustments occur at 4-week intervals based on clinical response, LVEF, and Valsalva LVOT gradient.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed.
Dialysis:
No dose adjustment needed. Mavacamten is not dialyzable.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
Avoid use in severe hepatic impairment (Child-Pugh C) due to increased exposure and limited clinical experience.
Pharmacology
Mechanism of Action
Mavacamten is a selective, allosteric, reversible inhibitor of cardiac myosin. It reduces the number of myosin-actin cross-bridges formed and the force they can generate. Mavacamten shifts the myosin population to an energy-sparing, super-relaxed state, thereby reducing contractility and improving cardiac energetics. In obstructive hypertrophic cardiomyopathy (oHCM), this leads to a reduction in left ventricular outflow tract (LVOT) obstruction.
Pharmacokinetics
Absorption:
Bioavailability:
Not available
Tmax:
1-4 hours
FoodEffect:
Food does not affect the extent of absorption, but may delay Tmax by 1-2 hours. Can be taken with or without food.
Distribution:
Vd:
Approximately 1000 L (suggests extensive tissue distribution)
ProteinBinding:
97-98%
CnssPenetration:
Limited
Elimination:
HalfLife:
6-9 days (terminal half-life, can be prolonged with CYP2C19 poor metabolizers)
Clearance:
Not available
ExcretionRoute:
Fecal (67%), Renal (33%)
Unchanged:
Less than 1% (urine), 16% (feces)
Pharmacodynamics
OnsetOfAction:
Not precisely defined, but clinical effects (reduction in LVOT gradient) observed within weeks.
PeakEffect:
Steady state concentrations reached after approximately 6 weeks.
DurationOfAction:
Due to long half-life, effects persist for several weeks after discontinuation.
Safety & Warnings
BLACK BOX WARNING
HEART FAILURE: Mavacamten reduces left ventricular ejection fraction (LVEF) and can cause heart failure. Echocardiogram assessments of LVEF are required prior to and during treatment with Camzyos. Initiation of Camzyos in patients with LVEF <55% is not recommended. Interrupt Camzyos if LVEF <50% at any visit or if the patient experiences symptoms of heart failure. Concomitant use of Camzyos with certain cytochrome P450 (CYP) inhibitors or inducers, or with other agents that reduce cardiac contractility, is contraindicated.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening chest pain
Severe dizziness or fainting
Feeling extremely tired or weak
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
* Dizziness
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice and guidance on managing side effects.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening chest pain
Severe dizziness or fainting
Feeling extremely tired or weak
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
* Dizziness
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice and guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- New or worsening shortness of breath
- Unusual fatigue or weakness
- Swelling in your legs, ankles, or feet
- Sudden weight gain
- Dizziness or lightheadedness
- Fainting spells
- Chest pain
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a history of heart failure, also known as a weak heart.
If you have any of the following health conditions:
+ An active infection
+ An abnormal heartbeat, such as atrial fibrillation (Afib)
If you are currently taking any of the following medications:
+ Diltiazem
+ Disopyramide
+ Ranolazine
+ Verapamil
Please note that this is not an exhaustive list of all potential interactions between this medication and other drugs or health conditions. Therefore, it is crucial to discuss all of your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a history of heart failure, also known as a weak heart.
If you have any of the following health conditions:
+ An active infection
+ An abnormal heartbeat, such as atrial fibrillation (Afib)
If you are currently taking any of the following medications:
+ Diltiazem
+ Disopyramide
+ Ranolazine
+ Verapamil
Please note that this is not an exhaustive list of all potential interactions between this medication and other drugs or health conditions. Therefore, it is crucial to discuss all of your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To avoid potential interactions, do not consume grapefruit or grapefruit juice while taking this drug.
This medication can cause harm to an unborn baby. Therefore, a pregnancy test will be conducted before you start taking this drug to confirm that you are not pregnant. If you are capable of becoming pregnant, it is crucial to use effective birth control during treatment and for a certain period after the last dose. Birth control products containing ethinyl estradiol and norethindrone can be used with this medication. However, other hormone-based birth control methods may not be as effective in preventing pregnancy while taking this drug. Consult your doctor to discuss suitable birth control options and the duration of use. If you become pregnant, notify your doctor immediately.
If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
To avoid potential interactions, do not consume grapefruit or grapefruit juice while taking this drug.
This medication can cause harm to an unborn baby. Therefore, a pregnancy test will be conducted before you start taking this drug to confirm that you are not pregnant. If you are capable of becoming pregnant, it is crucial to use effective birth control during treatment and for a certain period after the last dose. Birth control products containing ethinyl estradiol and norethindrone can be used with this medication. However, other hormone-based birth control methods may not be as effective in preventing pregnancy while taking this drug. Consult your doctor to discuss suitable birth control options and the duration of use. If you become pregnant, notify your doctor immediately.
If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Excessive reduction in LVEF
- Symptoms of heart failure (e.g., severe dyspnea, hypotension, cardiogenic shock)
What to Do:
There is no specific antidote for mavacamten overdose. Management should be supportive and directed at treating clinical signs and symptoms. Monitor LVEF and hemodynamic status closely. If heart failure develops, initiate standard medical therapy for heart failure. Mavacamten is highly protein-bound and not dialyzable. Contact a poison control center (e.g., 1-800-222-1222) for further guidance.
Drug Interactions
Contraindicated Interactions
- Concomitant use with moderate to strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, omeprazole, ticlopidine)
- Concomitant use with moderate to strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir, verapamil, diltiazem)
- Concomitant use with moderate to strong CYP2C19 inducers (e.g., rifampin, carbamazepine, phenytoin)
- Concomitant use with moderate to strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort)
Major Interactions
- P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine, amiodarone, dronedarone) - may increase mavacamten exposure
- Other negative inotropes (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, disopyramide) - increased risk of heart failure or systolic dysfunction
Moderate Interactions
- Weak CYP2C19 inhibitors (e.g., cimetidine, esomeprazole)
- Weak CYP3A4 inhibitors (e.g., ciprofloxacin, erythromycin)
- Weak CYP2C19 inducers (e.g., modafinil)
- Weak CYP3A4 inducers (e.g., efavirenz)
Minor Interactions
- Not specifically listed as minor interactions with clinical significance requiring dose adjustment for mavacamten itself.
Monitoring
Baseline Monitoring
Left Ventricular Ejection Fraction (LVEF)
Rationale: To establish baseline cardiac function and assess risk of heart failure.
Timing: Prior to initiation of therapy.
Valsalva Left Ventricular Outflow Tract (LVOT) Gradient
Rationale: To establish baseline obstruction severity and guide initial dosing.
Timing: Prior to initiation of therapy.
Symptoms of heart failure (e.g., dyspnea, fatigue, edema)
Rationale: To assess baseline clinical status and monitor for worsening.
Timing: Prior to initiation of therapy.
Routine Monitoring
LVEF
Frequency: Before dose escalation, at Week 4, Week 8, and Week 12 after initiation, and then every 12 weeks thereafter.
Target: >50%
Action Threshold: If LVEF <50%, interrupt treatment. If LVEF <30% or symptomatic heart failure, permanently discontinue.
Valsalva LVOT Gradient
Frequency: Before dose escalation, at Week 4, Week 8, and Week 12 after initiation, and then every 12 weeks thereafter.
Target: <30 mmHg (resting) or <50 mmHg (Valsalva)
Action Threshold: Used to guide dose titration (e.g., if LVOT gradient âĨ50 mmHg and LVEF âĨ50%, consider dose increase).
Symptoms of heart failure
Frequency: Regularly, at each clinical visit.
Target: Improvement or stability
Action Threshold: Worsening symptoms of heart failure should prompt LVEF assessment and potential treatment interruption/discontinuation.
Symptom Monitoring
- Dyspnea (shortness of breath)
- Fatigue
- Peripheral edema (swelling in legs/ankles)
- Weight gain
- Chest pain
- Palpitations
- Dizziness or lightheadedness
- Syncope (fainting)
Special Patient Groups
Pregnancy
Mavacamten may cause fetal harm when administered to a pregnant woman. Based on animal studies, mavacamten can cause adverse developmental outcomes. Advise pregnant women of the potential risk to a fetus. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment. Females of reproductive potential should use effective contraception during treatment and for 6 months after the last dose.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental outcomes based on animal data.
Second Trimester:
Potential for adverse developmental outcomes based on animal data.
Third Trimester:
Potential for adverse developmental outcomes based on animal data.
Lactation
It is not known whether mavacamten is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, including heart failure, advise women not to breastfeed during treatment with Camzyos and for 6 months after the last dose.
Infant Risk:
High (L5 - Contraindicated)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in pediatric patients.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (âĨ65 years) and younger patients. No dose adjustment is required based on age alone. However, older patients may be more sensitive to the effects of the drug and may have a higher incidence of comorbidities or concomitant medications that require careful consideration.
Clinical Information
Clinical Pearls
- Camzyos is part of a REMS (Risk Evaluation and Mitigation Strategy) program due to the risk of heart failure. Prescribers, pharmacies, and patients must be enrolled.
- Strict adherence to LVEF and LVOT gradient monitoring is crucial for safe and effective use.
- Patients must be educated on the importance of reporting any symptoms of heart failure immediately.
- Significant drug-drug interactions exist, especially with CYP2C19 and CYP3A4 inhibitors/inducers, and other negative inotropes. A thorough medication review is essential before initiation and during therapy.
- The long half-life means that effects (both therapeutic and adverse) can persist for several weeks after discontinuation.
Alternative Therapies
- Beta-blockers (e.g., metoprolol, propranolol)
- Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem)
- Disopyramide
- Septal myectomy (surgical intervention)
- Alcohol septal ablation (interventional cardiology procedure)
Cost & Coverage
Average Cost:
Not available per 30 capsules
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.