Camzyos 15mg 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 is a medicine used to treat a 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 effectively. Camzyos works by helping the heart muscle relax more, making it easier for blood to flow out of the heart and improving its pumping ability.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food, but be sure to swallow the tablet whole. Do not chew, open, or break the tablet.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's crucial to complete the full course of treatment as prescribed.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.
What to Do If You Miss 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 avoid overdosing.
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food, but be sure to swallow the tablet whole. Do not chew, open, or break the tablet.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's crucial to complete the full course of treatment as prescribed.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.
What to Do If You Miss 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 avoid overdosing.
Lifestyle & Tips
- Adhere strictly to your prescribed dosing schedule.
- Attend all scheduled doctor's appointments and echocardiograms, as these are crucial for monitoring your heart function and ensuring the medication is safe and effective for you.
- Report any new or worsening symptoms of heart failure (e.g., shortness of breath, swelling, unusual fatigue, rapid weight gain) immediately to your doctor.
- Inform all healthcare providers, including dentists and pharmacists, that you are taking Camzyos.
- Avoid taking any new medications, including over-the-counter drugs, herbal supplements, or vitamins, without first discussing them with your doctor or pharmacist, due to potential serious drug interactions.
- Limit or avoid alcohol consumption as advised by your doctor.
- Maintain a healthy lifestyle, including a balanced diet and regular exercise, as recommended by your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 5 mg orally once daily. Titrate based on left ventricular ejection fraction (LVEF) and left ventricular outflow tract (LVOT) gradient. Maximum dose 15 mg once daily.
Dose Range:
2.5 - 15 mg
Condition-Specific Dosing:
titration:
Dose titration should occur at 4-week intervals based on LVEF and LVOT gradient. If LVEF <50% at any visit, interrupt treatment. If LVEF âĨ50% and LVOT gradient <30 mmHg, consider increasing dose. If LVEF âĨ50% and LVOT gradient âĨ30 mmHg, maintain dose. If LVEF <50% and patient is symptomatic, reduce dose or interrupt treatment. If LVEF <30% or symptomatic heart failure, discontinue treatment.
concomitant_medications:
Lower starting dose (2.5 mg) if co-administered with moderate CYP2C19 inhibitors or moderate CYP3A4 inhibitors. Avoid concomitant use with strong CYP2C19 inhibitors, strong CYP3A4 inhibitors, or strong CYP2C19/CYP3A4 inducers.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
No dose adjustment required.
Dialysis:
Not studied, but unlikely to be significantly removed by dialysis due to high protein binding and large volume of distribution.
Hepatic Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
Not studied in patients with severe hepatic impairment. Use is not recommended.
Pharmacology
Mechanism of Action
Mavacamten is a selective, allosteric, reversible cardiac myosin inhibitor. It reduces the number of myosin-actin cross-bridges formed and the force they can generate. Mavacamten shifts the myosin population to a state of lower energy consumption, reducing contractility and improving diastolic function in hypertrophic cardiomyopathy (HCM). This leads to a reduction in left ventricular outflow tract (LVOT) obstruction.
Pharmacokinetics
Absorption:
Bioavailability:
Not available
Tmax:
1 to 4 hours
FoodEffect:
Food has no clinically significant effect on the pharmacokinetics of mavacamten.
Distribution:
Vd:
Approximately 1000 L
ProteinBinding:
>97%
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal half-life is approximately 6-9 days (range 3-13 days)
Clearance:
Not available
ExcretionRoute:
Fecal (approximately 67%), Urine (approximately 20%)
Unchanged:
Less than 1% (urine)
Pharmacodynamics
OnsetOfAction:
Not precisely defined, but clinical effects (LVOT gradient reduction) 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
RISK OF 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 contraindicated. 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 negative inotropes, is contraindicated due to the risk of heart failure.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or 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 not everyone will experience them. If you encounter any of the following side effects, or if you have any other concerns, contact your doctor for advice:
- Dizziness
Please note that this list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also a valuable resource for guidance on managing side effects.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or 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 not everyone will experience them. If you encounter any of the following side effects, or if you have any other concerns, contact your doctor for advice:
- Dizziness
Please note that this list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also a valuable resource for 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
- Chest pain or pressure
- Dizziness or lightheadedness
- Fainting spells (syncope)
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 combination 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 combination 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 may pose a risk to an unborn baby. Therefore, a pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you are of childbearing potential, it is crucial to use effective birth control during treatment and for a specified period after the last dose. Birth control products containing ethinyl estradiol and norethindrone can be used in conjunction with this medication. However, other hormone-based birth control methods may be less 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 may pose a risk to an unborn baby. Therefore, a pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you are of childbearing potential, it is crucial to use effective birth control during treatment and for a specified period after the last dose. Birth control products containing ethinyl estradiol and norethindrone can be used in conjunction with this medication. However, other hormone-based birth control methods may be less 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:
- 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 symptoms. Monitor LVEF and hemodynamic status closely. Consider measures to support cardiac function if severe heart failure develops. Due to high protein binding and long half-life, dialysis is unlikely to be effective. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Contraindicated Interactions
- Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine)
- Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, clarithromycin, ritonavir)
- Strong CYP2C19 inducers (e.g., rifampin, carbamazepine, phenytoin)
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin)
- Disopyramide (due to additive negative inotropic effects)
- Verapamil (due to additive negative inotropic effects)
- Diltiazem (due to additive negative inotropic effects)
- Beta-blockers (due to additive negative inotropic effects, unless used for rate control in atrial fibrillation)
Major Interactions
- Moderate CYP2C19 inhibitors (e.g., omeprazole, esomeprazole, cimetidine) - requires lower starting dose and careful monitoring.
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole) - requires lower starting dose and careful monitoring.
- Moderate CYP2C19 inducers (e.g., efavirenz, etravirine) - may require dose increase and careful monitoring.
- Moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine) - may require dose increase and careful monitoring.
- Other negative inotropes (e.g., other non-dihydropyridine calcium channel blockers, beta-blockers) - use with caution and monitor LVEF closely.
Moderate Interactions
- P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine, amiodarone, verapamil, diltiazem) - potential for increased mavacamten exposure.
- P-glycoprotein (P-gp) inducers (e.g., rifampin, St. John's Wort) - potential for decreased mavacamten exposure.
Minor Interactions
- Not specifically identified as minor interactions with clinical significance requiring specific action beyond general caution.
Monitoring
Baseline Monitoring
Left Ventricular Ejection Fraction (LVEF)
Rationale: To establish baseline cardiac function and assess eligibility for treatment (LVEF âĨ55%).
Timing: Prior to initiation of treatment.
Left Ventricular Outflow Tract (LVOT) Gradient
Rationale: To establish baseline obstruction severity and assess eligibility.
Timing: Prior to initiation of treatment.
Electrocardiogram (ECG)
Rationale: To assess cardiac rhythm and identify any pre-existing abnormalities.
Timing: Prior to initiation of treatment.
Concomitant Medications Review
Rationale: To identify potential drug-drug interactions, especially with CYP inhibitors/inducers and other negative inotropes.
Timing: Prior to initiation of treatment.
Routine Monitoring
Left Ventricular Ejection Fraction (LVEF)
Frequency: Prior to dose initiation, at 4 weeks, 8 weeks, and 12 weeks after initiation, and every 12 weeks thereafter. Also, prior to any dose increase.
Target: Maintain LVEF âĨ50%.
Action Threshold: If LVEF <50%, interrupt treatment. If LVEF <30% or symptomatic heart failure, discontinue treatment.
Left Ventricular Outflow Tract (LVOT) Gradient
Frequency: Prior to dose initiation, at 4 weeks, 8 weeks, and 12 weeks after initiation, and every 12 weeks thereafter. Also, prior to any dose increase.
Target: Aim for LVOT gradient <30 mmHg.
Action Threshold: Used in conjunction with LVEF for dose titration decisions.
Symptoms of Heart Failure
Frequency: Regularly, at each clinical visit.
Target: Absence or improvement of symptoms (e.g., dyspnea, fatigue, chest pain).
Action Threshold: Worsening symptoms, especially with LVEF reduction, warrant dose interruption or discontinuation.
Drug-Drug Interaction Monitoring
Frequency: Ongoing, especially when adding or discontinuing medications.
Target: Avoid contraindicated drugs; adjust dose for interacting drugs.
Action Threshold: If interacting drugs are initiated, monitor LVEF more frequently (e.g., weekly for 2 weeks).
Symptom Monitoring
- Dyspnea (shortness of breath)
- Fatigue
- Chest pain
- Palpitations
- Edema (swelling in legs, ankles, feet)
- Weight gain
- 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. Advise females of reproductive potential to 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 4 months after the last dose.
Infant Risk:
Potential for serious adverse reactions, including heart failure.
Pediatric Use
The safety and effectiveness of Camzyos in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between geriatric patients (âĨ65 years) and younger patients. No specific dose adjustment is required based on age.
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 in the Camzyos REMS program.
- Strict adherence to LVEF monitoring is critical for safe use. Patients must understand the importance of regular echocardiograms.
- Patients should be educated on the symptoms of heart failure and instructed to seek immediate medical attention if they experience them.
- Counsel patients extensively on potential drug-drug interactions, especially with strong and moderate CYP inhibitors/inducers and other negative inotropes.
- Due to its long half-life, the effects of mavacamten can persist for several weeks after discontinuation, and LVEF monitoring should continue during this period.
- The 2.5 mg dose is primarily for patients on concomitant moderate CYP2C19 or CYP3A4 inhibitors.
Alternative Therapies
- Beta-blockers (e.g., metoprolol, propranolol) - often first-line for symptom control in oHCM.
- Calcium channel blockers (e.g., verapamil, diltiazem) - used for symptom control.
- Disopyramide - an antiarrhythmic with negative inotropic effects, used off-label for oHCM.
- Surgical septal myectomy - invasive procedure to remove thickened heart muscle.
- Alcohol septal ablation - less invasive procedure to reduce septal thickness.
Cost & Coverage
Average Cost:
Not available (highly variable, typically very high) per 30 capsules
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and often LVEF monitoring documentation)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. 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 provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you 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, and the time it occurred.