This website is best viewed Tip: Always keep your doctor and treatment information handy. APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of . They work by reducing how hard the heart has to squeeze with each beat. You may also report side effects to Bristol Myers Squibb at 1-800-721-5072. Sometimes, it can be hard to remember all you want to say. 1-800-721-5072 or www.bms.com. are breastfeeding or plan to breastfeed. Image source: The Motley Fool. Please see US Full Prescribing Information, including Boxed WARNING and Medication Guide. Then read about the clinical study results below. Information collected on this form is for your use only and will not be saved or transmitted. Numeric values and special characters are not allowed. induced) Especially tell your healthcare provider if you: Possible side effects of CAMZYOSCAMZYOS may cause serious side effects, including heart failure (a condition where the heart cannot pump with enough force). So, the study that so far has been the main studyshowed in obstructive HCM, the benefits were on top of standard therapy, with the exception of disopyramide, which is the lesser used of the three drugs.. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS. APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of . Thank you for subscribing to Clinical Trials Arena. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. I dont think they stopped the standard therapies[Participants] could be on a beta blockerThey were allowed to continue beta blockers and calcium channel blockers. This offer may not be redeemed on prescriptions written for longer than 35 days, This offer is limited to one use per patient per lifetime and is non-transferrable. This website is best viewed This was measured during exercise testing on a bicycle or treadmill. Camzyos is a cardiac myosin inhibitor indicated for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). Take it as soon as possible and take your next dose at your regularly scheduled time the next day. CAMZYOS (mavacamten) may cause serious side effects, including: Heart failure, a condition where the heart cannot pump with enough force. It is not known if CAMZYOS passes into your breast milk. Some people (6%) also experienced a decrease in their LVEF. CAMZYOS is a prescription medicine used to treat: adults with symptomatic obstructive h ypertrophic c ardio m yopathy (obstructive HCM). BMS may also use my information in order to improve or develop its services and for other internal business purposes including analytics, communication services, and marketing activities. Swallow the capsule whole. Here are ways to help you learn more about CAMZYOS as well as other resources that may be available to you. This means: What should I discuss with my healthcare provider before starting CAMZYOS? By downloading this eBook, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Patients who move from commercial plans to state or federal healthcare programs will no longer be eligible, Patients pay as little as $0 in out-of-pocket costs per echocardiogram assessment, subject to an annual maximum benefit of $2,500. If youve been prescribed CAMZYOS, find out about our free trial offer to help you get started on treatment. WARNING: RISK OF HEART FAILURE CAMZYOS may cause serious side effects, including heart failure. In people with symptomatic obstructive HCM, reducing the connections between myosin and actin may decrease the obstruction and improve heart function (how the heart relaxes and fills with blood). Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with CAMZYOS. A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help . After you complete the form below, you can choose to download a PDF or save it directly to your contacts. What the data showed: From when they started the study to when it ended, people taking CAMZYOS reported an average change in score of +14, and those who took placebo reported an average change in score of +4. Also be sure The dosage is based on your medical. 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. Possibly a little more, maybe up to 40%. Before starting treatment with CAMZYOS, your healthcare provider will do an echocardiogram (echo) to assess your obstructive HCM. Higher scores represent better health status. Tell your healthcare provider or get medical help right away if you develop new or worsening shortness of breath, chest pain, fatigue, swelling in your legs, a racing sensation in your heart (palpitations), or rapid weight gain. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Keep CAMZYOS and all medicines out of the reach of children. How was this measured? If you have questions about the CAMZYOS REMS Program, ask your healthcare provider, visit www.CAMZYOSREMS.com, or call 1-833-628-7367. are pregnant or plan to become pregnant. CAMZYOSTM (mavacamten) is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). CAMZYOS may reduce how well hormonal birth control works. Patients are responsible for any costs that exceed the maximum amounts, To receive the Program benefits, claims must be submitted within 180 days of the date of service, The program may apply retroactively to out of pocket expenses that occurred within 180 days prior to the date of enrollment, The enrollment period is for 1 calendar year, Acceptance of this offer confirms that this offer is consistent with patients insurance. Your healthcare provider will do a pregnancy test before you start treatment with CAMZYOS. Co-pay assistance is not valid where the entire cost of the prescription is reimbursed by insurance, Patients are not eligible if they have prescription insurance coverage through a state or federal healthcare program, including but not limited to Medicare, Medicaid, Medigap, CHAMPUS, TRICARE, Veterans Affairs (VA), or Department of Defense (DOD) programs; patients who move from commercial to state or federal healthcare program insurance will no longer be eligible, Cash-paying patients are not eligible for co-pay assistance, Patients must be 18 years of age or older, Patients must live in the United States or United States territories, Eligible patients with an activated co-pay card and a valid prescription may pay as little as $10 per 30-day supply, subject to a maximum benefit of $15,000 per calendar year, The enrollment period is for the first 2 years and then re-enrollment is required each calendar year thereafter, Patients, pharmacists, and prescribers may not seek reimbursement from health insurance, health savings or flexible spending accounts, or any third party, for any part of the benefit received by the patient through this offer, Acceptance of this offer confirms that this offer is consistent with patients insurance. Talk to your healthcare provider about the best way to feed your baby if you take CAMZYOS. Talk to your healthcare provider for more information about echos and your echo schedule. A serious side effect is a side effect that can sometimes be life-threatening and lead to death. Oct 26, 2022, 8:00 a.m. From time to time the Privacy Policy may change and I understand that I should check the website at www.bms.com for the most recent version. Serious Interactions. Keep this information in a safe place so you can refer to it before and during your treatment. Use of my information will be governed by the BMS Privacy Policy. all of the medicines you take before and during treatment with CAMZYOS, U.S. Full Prescribing Information, including, New York Heart Association (NYHA) classification, Patients must have commercial (private) insurance, but their coverage does not cover the full cost of the prescription. 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Please check back at a later time. Since FDA approval in April has anyone (non-clinical trial patient) actually obtained a prescription and had it filled? CAMZYOS will not work for everyone. HCM is prevalent in one in every 500 people worldwide and is mainly caused by mutations in genes encoding muscle proteins of the sarcomere. Capsule: contains black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. 3. Nurse Navigators can provide general information about CAMZYOS but cannot provide medical advice. 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. 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. icons as you read: CAMZYOS is a prescription medicine used to treat: adults with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM).