WARNINGS
CAMZYOS may cause serious side effects, including:
Heart failure, a condition where the heart cannot pump with enough force. Heart failure is a serious condition that can lead to death. You must have echocardiograms before you take your first dose and during your treatment with CAMZYOS to help your healthcare provider understand how your heart is responding to CAMZYOS. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS. Tell your healthcare provider or get medical help right away if you develop new or worsening:
shortness of breath
swelling in your legs
chest pain
a racing sensation in your heart (palpitations)
fatigue
rapid weight gain
The risk of heart failure is also increased when CAMZYOS is taken with certain other medicines. Tell your healthcare provider about the medicines you take, both prescribed and obtained over-the-counter, before and during treatment with CAMZYOS.
Because of the serious risk of heart failure, CAMZYOS is only available through a restricted program called the CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program.
Your healthcare provider must be enrolled in the CAMZYOS REMS Program in order for you to be prescribed CAMZYOS.
Before you take CAMZYOS, you must enroll in the CAMZYOS REMS Program. Talk to your healthcare provider about how to enroll in the CAMZYOS REMS Program. You will be given information about the program when you enroll.
Before you take CAMZYOS, your healthcare provider and pharmacist will make sure you understand how to take CAMZYOS safely, which will include returning for echocardiograms when advised by your healthcare provider.
CAMZYOS can only be dispensed by a certified pharmacy that participates in the CAMZYOS REMS Program. Your healthcare provider can give you information on how to find a certified pharmacy. You will not be able to get CAMZYOS at a local pharmacy.
If you have questions about the CAMZYOS REMS Program, ask your healthcare provider, go to www.CAMZYOSREMS.com, or call 1-833-628-7367.
See the section SIDE EFFECTS, below for information about side effects.
USES
What is CAMZYOS?
CAMZYOS is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). CAMZYOS may improve your symptoms and your ability to be active. It is not known if CAMZYOS is safe and effective in children.
HOW TO USE
Take CAMZYOS exactly as your healthcare provider tells you to take it.
Do not change your dose of CAMZYOS without talking to your healthcare provider first.
Take CAMZYOS 1 time a day.
Swallow the capsule whole. Do not break, open, or chew the capsule.
If you miss a dose of CAMZYOS, take it as soon as possible and take your next dose at your regularly scheduled time the next day. Do not take 2 doses on the same day to make up for a missed dose.
Your healthcare provider may change your dose, temporarily stop, or permanently stop your treatment with CAMZYOS if you have certain side effects.
If you take too much CAMZYOS, call your healthcare provider or go to the nearest hospital emergency room right away
CAMZYOS may cause serious side effects, including:
Heart failure. See “What is the most important information I should know about
CAMZYOS?”
The most common side effects of CAMZYOS include: dizziness and fainting (syncope).
These are not all of the possible side effects of CAMZYOS.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Bristol-Myers Squibb at 1-800-721-5072.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CAMZYOS for a condition for which it was not prescribed. Do not give CAMZYOS to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about CAMZYOS that is written for health professionals.
What are the ingredients in CAMZYOS?
Active ingredient: mavacamten
Inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate (non-bovine), mannitol, and silicon dioxide.
The capsule contains black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide.
OVERDOSE
Clinical Experience and Effects
• Cardiovascular effects may include reduced LVEF (left ventricular ejection fraction),
heart failure, hypotension, and asystole refractory to medical intervention.
• Neurological effects may include dizziness and syncope.
• An infant death was reported after accidental ingestion of three 15 mg capsules (45 mg).
• An adult administered a single dose of 144 mg developed a vasovagal reaction,
hypotension, and asystole, but the subject recovered.
Management
• Discontinue CAMZYOS treatment.
• Provide medically supportive measures to maintain hemodynamic stability and monitor
left ventricular function.
• Consider administering activated charcoal (pediatric dose is 1g/kg; adult dose is 50g)
within 2 hours of ingestion in addition to other supportive measures. The benefit of
activated charcoal is negligible after 6 hours [see Clinical Pharmacology (12.3)].
• Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for
additional overdose management recommendations.
MISSED DOSE
If you miss a dose of CAMZYOS, take it as soon as possible and take your next dose at your regularly scheduled time the next day. Do not take 2 doses on the same day to make up for a missed dose.
STORAGE
Store CAMZYOS at room temperature between 68-degrees F to 77-degrees F (20-degrees C to 25-degrees C).
Keep CAMZYOS and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 04/2025
Prescribing Information: revision date 04/2025
1.) Potential for Other Drugs to Affect Plasma Concentrations of CAMZYOS
Mavacamten is primarily metabolized by CYP2C19 and to a lesser extent by CYP3A4 and CYP2C9.
Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect the exposures of mavacamten and Clinical Pharmacology.
Table 1: Established and Potentially Significant Pharmacokinetic Drug Interactions
with CAMZYOS
Impact of Other Drugs on CAMZYOS
Strong CYP2C19 Inhibitors
Clinical Impact Concomitant use with a strong CYP2C19 inhibitor increases mavacamten exposure, which may increase the risk of heart failure due to systolic dysfunction.
Prevention or Management: Concomitant use with a strong CYP2C19 inhibitor is contraindicated.
Moderate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers
Clinical Impact: Concomitant use with a moderate to strong CYP2C19 inducer or a moderate to strong CYP3A4 inducer decreases mavacamten exposure, which may reduce CAMZYOS’ efficacy. The risk of heart failure due to systolic dysfunction may increase with discontinuation of these inducers as the levels of induced enzyme normalizes.
Prevention or Management: Concomitant use of a moderate to strong CYP2C19 inducer or a moderate to strong CYP3A4 inducer is contraindicated.
Weak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors
Clinical Impact: Concomitant use with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases mavacamten exposure, which may increase the risk of adverse drug reactions.
Prevention or Management: Initiate CAMZYOS at the recommended starting dosage of 5 mg orally once daily in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor.Reduce dose of CAMZYOS to the next lower daily (mg) dose level (i.e., 15 mg to 10 mg, 10 mg to 5 mg, or 5 mg to 2.5 mg) in patients who areon CAMZYOS treatment and intend to initiate a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Avoid initiation of concomitant weak CYP2C19 and moderate CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available.For short-term use (e.g., 1 week), interrupt CAMZYOS for the duration of treatment with a weak inhibitor of CYP2C19 or a moderate inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy.
Moderate CYP2C19 Inhibitors or Strong CYP3A4 Inhibitors
Clinical Impact: Concomitant use with a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor increases mavacamten exposure, which may increase the risk of adverse drug reactions. Discontinuing use of a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor after long-term concomitant use may decrease mavacamten exposure, which may reduce CAMZYOS’ efficacy.
Prevention or Management: Initiate CAMZYOS at a starting dosage of 2.5 mg orally once daily in patients who are on stable therapy with a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Reduce dose of CAMZYOS to the next lower daily (mg) dose level (i.e., 15 mg to 10 mg, 10 mg to 5 mg, or 5 mg to 2.5 mg) in patients who are on CAMZYOS and intend to initiate a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Avoid initiation of concomitant moderate CYP2C19 and strong CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available. An increase in dose of CAMZYOS may be needed if the moderate inhibitor of CYP2C19 or strong inhibitor of CYP3A4 is discontinued after long-term concomitant use. Monitor for new or worsening symptoms. For short-term use (e.g., 1 week), interrupt CAMZYOS for the duration of treatment with a moderate inhibitor of CYP2C19 or a strong inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy.
2.) Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs
Certain CYP3A4, CYP2C9, and CYP2C19 Substrates Mavacamten is an inducer of CYP3A4, CYP2C9, and CYP2C19. Concomitant use with CYP3A4, CYP2C9, or CYP2C19 substrates may reduce plasma concentration of these drugs.. Closely monitor when CAMZYOS is used with concomitant CYP3A4, CYP2C9 or CYP2C19 substrates unless otherwise recommended in the Prescribing Information. Certain Combined Hormonal Contraceptives Progestin and ethinyl estradiol are CYP3A4 substrates. Concomitant use of CAMZYOS may decrease exposures of certain progestins, which may lead to contraceptive failure. Combined hormonal contraceptives (CHCs) containing a combination of ethinyl estradiol and norethindrone may be used with mavacamten, but if other CHCs are used,advise patients to add nonhormonal contraception (such as condoms) or use an alternativecontraceptive method that is not affected by CYP450 enzyme induction (e.g., intrauterinesystem) during concomitant use and for 4 months after the last dose of CAMZYOS.
3.) Drugs That Reduce Cardiac Contractility
Expect additive negative inotropic effects of CAMZYOS and other drugs that reduce cardiac contractility. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited. If concomitant therapy with a negative inotrope is initiated, or if the dose of a negative inotrope is increased, monitor LVEF closely until stable doses and clinical response have been achieved.
Before taking CAMZYOS, tell your healthcare provider about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. CAMZYOS may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with CAMZYOS. You may also report your pregnancy by calling Bristol-Myers Squibb at 1-800-721-5072 or www.bms.com.
If you are a female and able to become pregnant:
Your healthcare provider will do a pregnancy test before you start treatment with CAMZYOS.
You should use effective birth control (contraception) during treatment with CAMZYOS and for 4 months after your last dose of CAMZYOS.
CAMZYOS may reduce how well some hormonal birth control works. Talk to your healthcare provider about the use of effective forms of birth control during treatment with CAMZYOS.
are breastfeeding or plan to breastfeed. It is not known if CAMZYOS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with CAMZYOS.
Before and during CAMZYOS treatment, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure. Do not stop or change the dose of a medicine or start a new medicine without telling your healthcare provider.
Especially tell your healthcare provider if you:
Take over-the-counter medicines such as omeprazole (for example, Prilosec), esomeprazole (for example, Nexium), or cimetidine (for example, Tagamet).
Take other medicines to treat your obstructive HCM disease.
Develop an infection.
