Camzyos 2.5mg 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 inhibitor
Pregnancy Category
Not available
FDA Approved
Apr 2022
DEA Schedule
Not Controlled
Overview
What is this medicine?
Camzyos (mavacamten) is a medication used to treat a specific type of heart condition called obstructive hypertrophic cardiomyopathy (oHCM). It works by helping your heart muscle relax more, which allows blood to flow better out of your heart and reduces symptoms like shortness of breath and chest pain.
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 feeling well.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, 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's 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 feeling well.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, 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's 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
- Take Camzyos exactly as prescribed by your doctor, usually once a day.
- Do not stop taking Camzyos without talking to your doctor, as this can worsen your condition.
- Avoid grapefruit juice and St. John's Wort while taking Camzyos, as they can affect how the medication works.
- Inform your doctor about all medications, supplements, and herbal products you are taking, especially new ones.
- Attend all scheduled doctor appointments and echocardiograms to monitor your heart function.
- Report any new or worsening symptoms of heart failure immediately to your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 5 mg orally once daily. Titrate based on LVEF and LVOT gradient at weeks 4, 8, and 12, and then every 12 weeks.
Dose Range:
2.5 - 15 mg
Condition-Specific Dosing:
obstructive_hypertrophic_cardiomyopathy:
Initial dose 5 mg orally once daily. Subsequent doses (2.5 mg, 5 mg, 10 mg, 15 mg) are determined by LVEF and LVOT gradient measurements. If LVEF < 50% or LVOT gradient < 30 mmHg, dose reduction or interruption may be required. Discontinue if LVEF < 30%.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
Dialysis:
No dose adjustment recommended; mavacamten is highly protein-bound and unlikely to be removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
Avoid use in patients with severe hepatic impairment (Child-Pugh Class C).
Pharmacology
Mechanism of Action
Mavacamten is an allosteric and reversible inhibitor of cardiac myosin ATPase. It reduces the number of myosin-actin cross-bridges formed, thereby decreasing myocardial contractility and improving diastolic function in patients with obstructive hypertrophic cardiomyopathy (oHCM).
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 85%
Tmax:
1 to 4 hours
FoodEffect:
A high-fat meal decreases Cmax by 18% and AUC by 16%, which is not clinically significant.
Distribution:
Vd:
Approximately 100 L
ProteinBinding:
>97%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 6 to 10 days (terminal half-life)
Clearance:
Not available
ExcretionRoute:
Feces (approximately 60%), urine (approximately 37%)
Unchanged:
<1% in urine
Pharmacodynamics
OnsetOfAction:
Not precisely defined, but clinical effects (e.g., reduction in LVOT gradient) observed within weeks of initiation.
PeakEffect:
Steady-state concentrations are reached after approximately 6 weeks of once-daily dosing.
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 assessment of LVEF and LVOT gradient is required prior to and during treatment. Concomitant use of certain CYP inhibitors or inducers, or other negative inotropes, 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. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:
* 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:
* 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.
Seek Immediate Medical Attention If You Experience:
- New or worsening shortness of breath
- Unusual tiredness or fatigue
- Swelling in your legs, ankles, or feet
- Rapid or irregular heartbeat
- Dizziness or lightheadedness
- Fainting spells
- Chest pain or pressure
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. It is crucial to discuss all of your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or change the dose 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. It is crucial to discuss all of your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or change the dose 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 recommended 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 recommended 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:
- Severe reduction in left ventricular ejection fraction (LVEF)
- Signs and symptoms of heart failure (e.g., severe dyspnea, hypotension, edema)
What to Do:
There is no specific antidote for mavacamten overdose. Treatment should be symptomatic and supportive. Monitor LVEF and hemodynamic status closely. Consider measures to support cardiac function. Due to high protein binding, dialysis is unlikely to be effective. Contact a poison control center (e.g., 1-800-222-1222) for specific guidance.
Drug Interactions
Contraindicated Interactions
- Moderate to strong CYP2C19 inhibitors (e.g., fluconazole, omeprazole)
- Moderate to strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ritonavir, grapefruit juice)
- Moderate to strong CYP2C19 inducers (e.g., rifampin, carbamazepine, phenytoin)
- Moderate to strong CYP3A4 inducers (e.g., rifampin, St. John's Wort, phenobarbital)
- Disopyramide
- Dronedarone
- Other negative inotropes (e.g., verapamil, diltiazem, beta-blockers) in combination with mavacamten
Major Interactions
- Strong CYP inhibitors/inducers (as listed above)
- Other negative inotropes (e.g., beta-blockers, non-dihydropyridine calcium channel blockers) - concomitant use requires careful monitoring and dose adjustment of mavacamten or the other agent.
Moderate Interactions
- Weak CYP2C19 inhibitors (e.g., cimetidine)
- Weak CYP3A4 inhibitors (e.g., amiodarone)
- Weak CYP2C19 inducers (e.g., efavirenz)
- Weak CYP3A4 inducers (e.g., bosentan)
Monitoring
Baseline Monitoring
Left Ventricular Ejection Fraction (LVEF)
Rationale: To establish baseline cardiac function and guide initial dosing.
Timing: Prior to initiation of treatment.
Left Ventricular Outflow Tract (LVOT) Gradient
Rationale: To establish baseline obstruction severity and guide initial dosing.
Timing: Prior to initiation of treatment.
Electrocardiogram (ECG)
Rationale: To assess cardiac rhythm and conduction.
Timing: Prior to initiation of treatment.
Liver Function Tests (LFTs)
Rationale: To assess hepatic function, especially given hepatic metabolism and contraindication in severe impairment.
Timing: Prior to initiation of treatment.
Routine Monitoring
Left Ventricular Ejection Fraction (LVEF)
Frequency: At weeks 4, 8, and 12 after initiation or dose adjustment, then every 12 weeks.
Target: Maintain LVEF âĨ 50%.
Action Threshold: If LVEF < 50%, reduce dose or interrupt treatment. If LVEF < 30%, discontinue treatment.
Left Ventricular Outflow Tract (LVOT) Gradient
Frequency: At weeks 4, 8, and 12 after initiation or dose adjustment, then every 12 weeks.
Target: Reduce to < 30 mmHg.
Action Threshold: If LVOT gradient < 30 mmHg and LVEF âĨ 50%, consider dose reduction if symptoms are controlled. If LVOT gradient < 30 mmHg and LVEF < 50%, reduce dose or interrupt treatment.
Symptoms of Heart Failure
Frequency: Continuously
Target: Improvement or stability of symptoms.
Action Threshold: Worsening symptoms (e.g., dyspnea, fatigue, edema) may indicate reduced LVEF and require immediate evaluation.
Symptom Monitoring
- Shortness of breath (dyspnea)
- Chest pain or pressure
- Fatigue
- Dizziness or lightheadedness
- Fainting (syncope)
- Swelling in legs, ankles, or feet (edema)
- Palpitations
Special Patient Groups
Pregnancy
Based on animal studies, mavacamten may cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus. A pregnancy test is recommended prior to initiation of treatment in females of reproductive potential. Effective contraception is recommended during treatment and for 6 months after the last dose.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data.
Second Trimester:
Potential for fetal harm based on animal data.
Third Trimester:
Potential for fetal harm based on animal data.
Lactation
There are no data on the presence of mavacamten in human milk, the effects on the breastfed infant, or the effects on milk production. Due to the potential for serious adverse reactions in a breastfed infant, advise women not to breastfeed during treatment with mavacamten and for 4 months after the last dose.
Infant Risk:
Potential for serious adverse reactions (e.g., cardiac dysfunction) due to systemic exposure.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Mavacamten is not indicated 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 specific dose adjustment is required based on age, but monitor for adverse effects as with all patients.
Clinical Information
Clinical Pearls
- Mavacamten 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 in the CAMZYOS REMS Program.
- Strict adherence to LVEF monitoring is crucial for patient safety. Patients must undergo echocardiograms at specified intervals.
- Significant drug-drug interactions exist, particularly with CYP2C19 and CYP3A4 inhibitors and inducers, and other negative inotropes. A thorough medication review is essential before and during treatment.
- Patients should be educated on the signs and symptoms of heart failure and instructed to seek immediate medical attention if they occur.
- Due to its long half-life, the effects of mavacamten can persist for several weeks after discontinuation, and drug interactions may continue during this period.
Alternative Therapies
- Beta-blockers (e.g., metoprolol, propranolol)
- Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem)
- Surgical septal myectomy
- Alcohol septal ablation
Cost & Coverage
Average Cost:
Highly variable, typically >$10,000 per 30 capsules
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. It is essential to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. It is essential to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.