Please see additional Important Safety Information, including Boxed WARNING,
throughout and US Full Prescribing Information and Medication Guide for CAMZYOS.
 MY DOCTOR What is CAMZYOS? CAMZYOS is a prescription medicine used to treat:  adults with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM). CAMZYOS may improve your symptoms and your ability to be active. It is not known if CAMZYOS is safe and effective in children. Select Important Safety Information WARNING: RISK OF HEART FAILURE  CAMZYOS may cause serious side effects, including heart failure. Heart failure, a condition where the heart cannot pump with enough force, 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. Echocardiograms (echos) are imaging tests, a type of ultrasound study, which take pictures of your heart and show how well your heart is working. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS.  Get medical help right away if you experience new or worsening symptoms, including:
The risk of heart failure is also increased when CAMZYOS is taken with certain other medications. 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. This means:  You and your healthcare provider must both be enrolled in the CAMZYOS REMS program in order to Your healthcare provider and pharmacist will make sure you understand how to take CAMZYOS safely, You can get CAMZYOS only from a certified pharmacy that is part of the CAMZYOS REMS program.  If you have questions about the CAMZYOS REMS Program, ask your healthcare provider, PREPARING FOR YOUR APPOINTMENT
Here is the information you provided as well as some suggested questions to ask your doctor. 1 TREATMENT AND MEDICAL HISTORY This section may help you talk to your doctor about your history and current treatment plan with symptomatic obstructive HCM. 2 SYMPTOMS AND IMPACT Even if you’re seeing the same doctor who diagnosed you, the following responses can help a doctor understand how you are feeling and what your treatment goals are. 1. 2. 3. 3 QUESTIONS Keep in mind that the questions provided are suggestions for topics you can discuss and are not meant as medical advice. Be sure to discuss any questions you have with your doctor. 3 QUESTIONS CAMZYOS is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). If you’re talking with a doctor about possible treatment options and want to learn more about CAMZYOS, below are some questions you may want to ask: If you and your doctor are considering CAMZYOS, be sure to discuss your medical history, prescription medicines, and over-the-counter medicines, including vitamins and herbal supplements. Your doctor is always the best source of information when it comes to your health. Notes Important Facts About CAMZYOS How should I take CAMZYOS? Take CAMZYOS exactly as your healthcare provider tells you.  1 time a day, by mouth Swallow the capsule whole  Do not break, open, bite, or chew the capsule Do not change your dose of CAMZYOS without talking to your healthcare provider first  Talk to your healthcare provider about the right dose for you. What if I miss a dose? Take it as soon as possible and take your next dose at your regularly scheduled time the next day. Do not take two 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. 3 QUESTIONS Notes Important Facts About CAMZYOS How should I take CAMZYOS? Take CAMZYOS exactly as your healthcare provider tells you. 1 time a day, by mouth Swallow the capsule whole Do not break, open, bite, or chew the capsule Do not change your dose of CAMZYOS without talking to your healthcare provider first Talk to your healthcare provider about the right dose for you. What if I miss a dose? Take it as soon as possible and take your next dose at your regularly scheduled time the next day. Do not take two 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. IMPORTANT FACTS ABOUT CAMZYOS Important Facts About CAMZYOS® (mavacamten) This is a summary of important information that you need to know about CAMZYOS. Your healthcare Look out for the following icons as you read: Talk to your healthcare provider Call a healthcare provider right away Helpful information to remember What is CAMZYOS? CAMZYOS is a prescription medicine used to treat: adults with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM). CAMZYOS may improve your symptoms and your ability to be active. It is not known if CAMZYOS is safe and effective in children. WARNING: RISK OF HEART FAILURE CAMZYOS may cause serious side effects, including heart failure. Heart failure, a condition where the heart cannot pump with enough force, 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. Echocardiograms (echos) are imaging tests, a type of ultrasound study, which take pictures of your heart and show how well your heart is working. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS. Get medical help right away if you experience new or worsening symptoms, including:
The risk of heart failure is also increased when CAMZYOS is taken with certain other medications. Tell your healthcare provider about the medicines you take, both prescribed and obtained over-the-counter, before and during treatment with CAMZYOS. IMPORTANT FACTS ABOUT CAMZYOS Continued 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. This means: You and your healthcare provider must both be enrolled in the CAMZYOS REMS program in order to Your healthcare provider and pharmacist will make sure you understand how to take CAMZYOS safely, You can get CAMZYOS only from a certified pharmacy that is part of the CAMZYOS REMS program. If you have questions about the CAMZYOS REMS Program, ask your healthcare provider, What should I discuss with my healthcare provider before starting CAMZYOS? Talk to 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 are pregnant during treatment with CAMZYOS. You may also report your pregnancy by calling Bristol Myers Squibb at 1-800-721-5072 or by visitng www.bms.com. If you are a female and able to become pregnant, your healthcare provider will do a pregnancy test before you start taking CAMZYOS. You should use an effective method of birth control (contraception) during treatment and for at least 4 months after your last dose of CAMZYOS. CAMZYOS may reduce how well hormonal birth control works. Talk to your healthcare provider about the use of effective forms of birth control during treatment with CAMZYOS.  You 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. What medicines should I discuss with my healthcare provider? Tell your healthcare provider about all of the medicines you take before and during treatment with CAMZYOS, including:
IMPORTANT FACTS ABOUT CAMZYOS Continued What medicines should I discuss with my healthcare provider? Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure. Especially tell your healthcare provider if you:
Do not stop or change the dose of a medicine or start a new medicine without telling your healthcare provider. What are the serious side effects of CAMZYOS? A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. CAMZYOS may cause serious side effects, including heart failure (a condition where the heart cannot pump with enough force). Get medical help right away if you experience new or worsening symptoms, including:
What are the most common side effects? The most common side effects of CAMZYOS include dizziness and fainting (syncope). Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of CAMZYOS. Talk to your healthcare provider for more information 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. How should I take CAMZYOS? Before starting treatment with CAMZYOS, your healthcare provider will do an echocardiogram (echo) to assess your obstructive HCM. Your heart must be regularly monitored with echos while on treatment to help your healthcare provider understand how your heart is responding to CAMZYOS. Talk to your healthcare provider for more information about echos and your echo schedule. IMPORTANT FACTS ABOUT CAMZYOS Continued How should I take CAMZYOS?  CAMZYOS comes in immediate release capsules, containing 2.5, 5, 10, or 15 mg of mavacamten. Each capsule is marked with the word MAVA and the number of milligrams (mg) it contains. Inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate (non-bovine), mannitol, and silicon dioxide. Capsule: contains black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. Take CAMZYOS exactly as your healthcare provider tells you. 1 time a day, by mouth Swallow the capsule whole Do not break, open, bite, or chew the capsule Do not change your dose of CAMZYOS without talking to your healthcare provider first Talk to your healthcare provider about the right dose for you. What if I miss a dose? 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. What if I take too much CAMZYOS? Call your healthcare provider or go to the nearest hospital emergency room right away. How should I store CAMZYOS? Store CAMZYOS capsules between 68°F-77°F (20°C-25°C). Keep CAMZYOS and all medicines out of the reach of children. For more information, please see the U.S. Full Prescribing Information, including Boxed WARNING, and Medication Guide for CAMZYOS. Talk to your healthcare provider for more information about this medication. 
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