Your heart must be regularly monitored with echos while on treatment to help your healthcare provider understand how your heart is responding to CAMZYOS. Before you take CAMZYOS, you must enroll in the CAMZYOS REMS Program. Take over-the-counter medications such as omeprazole (for example, Prilosec), esomeprazole (for example, Nexium), or cimetidine (for example, Tagamet). C. Enroll in the CAMZYOS REMS on behalf of the pharmacy by completing the Pharmacy Enrollment Form and submitting it to the REMS Online OR by printing and faxing to 833-299-9539 D. Train all relevant staff involved in dispensing CAMZYOS using the Program Overview and the Education Program for Healthcare Providers and Pharmacies 3. Inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate (non-bovine), mannitol, and silicon dioxide. 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. 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. You will be given information about the program when you enroll. What the data showed: People who took CAMZYOS had an average decrease in their LVOT gradient of 47 mmHg (started at 86 mmHg and went down to 38 mmHg), and people who took a placebo had an average decrease of 10 mmHg (started at 84 mmHg and went down to 73 mmHg). The most common side effects of CAMZYOS include dizziness and fainting (syncope). Swallow the capsule whole. 2022 MyoKardia, Inc., a Bristol-Myers Squibb company. Before starting treatment with CAMZYOS, your healthcare provider will do an echocardiogram (echo) to assess your obstructive HCM. Youll have access to live representatives and receive informative emails, tools, and materials. Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure. FINANCIAL RESOURCES Please enter a work/business email address. Your healthcare provider will do a pregnancy test before you start treatment with CAMZYOS. 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. Only in his 30s and about to become a father, he struggled along a simple bike path and even the stairs became his enemy. Learn how Dustin finally faced his symptomatic obstructive HCM and returned to a more active life with CAMZYOS. This action allows your heart muscle to relax more. These are not all of the possible side effects of CAMZYOS. Camzyos is supplied as capsules for oral administration. What is Camzyos? icons as you read: CAMZYOS is a prescription medicine used to treat: adults with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM). Patients, pharmacists, and healthcare providers must report the receipt of co-pay assistance benefits if required by patients insurance provider, All Program payments are for the benefit of the patient only, Offer valid only in the United States and United States territories, Void where prohibited by law, taxed, or restricted, The Program benefits are not transferable and is limited to one (1) per patient. I understand that the information I provide, along with information about my use of the materials and services, will be stored and used by Bristol Myers Squibb and parties acting on its behalf (BMS) to provide the support services to me. The phase IV clinical study is created by eHealthMe based on reports from the FDA, and is updated regularly. CAMZYOSTM (mavacamten) is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Before you take CAMZYOS, you must enroll in the CAMZYOS REMS Program. Use of my information will be governed by the BMS Privacy Policy. One group (123 people) took CAMZYOS and the other group (128 people) took a placebo. Your healthcare provider can work with you to help answer any questions you may have about this medication. CAMZYOS reduces systolic contraction and can cause heart failure or totally block ventricular function. Image source: The Motley Fool. To understand how CAMZYOS works, its helpful to know how certain proteins help contribute to the pumping action of your heart: Two proteins in the heart muscle, called myosin and actin, contribute to your heart pumping by connecting (making the heart contract) and releasing (allowing the heart to relax). You will not be able to get CAMZYOS at a local pharmacy. ketoconazole levels, efficacy (hepatic metab. Once your doctor prescribes CAMZYOS, and if you enroll in the MyCAMZYOS program, youll be assigned a dedicated Nurse Navigator* who will guide you through the services listed below: Once your doctor and you enroll in MyCAMZYOS, the Patient Access Specialists will start working with your insurance company to: Available from 8 am to 11 pm, Monday through Friday. Watch how CAMZYOS made a real difference in Dustin's life. Camzyos won approval on the basis of a 251-patient study called EXPLORER, in which patients randomized to take the drug had significantly better peak oxygen consumption and improved on a widely used measurement of heart failure when compared to those who got a placebo.Hirawat pointed to a share of patients taking the drug, 27%, whose heart failure symptoms "normalized" when referencing . These attributes provide a favourable marketing position for Camzyos, which GlobalData expects to generate nearly $1bn in sales worldwide by the year 2025. GlobalData Healthcare. When asked about the potential for Camzyos to have widespread market penetration, an EU-based GlobalData key opinion leader said: [The proportion of patients who will be treated with mavacamten in five years] depends entirely on the pricing and local policies. Do not change your dose of CAMZYOS without talking to your healthcare provider first. Clinical trials on Camzyos The FDA's approval of Camzyos (mavacamten) was based on data from the Phase III trial EXPLORER-HCM, which was a placebo-controlled, multi-centre, double-blind, randomised parallel group study. 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. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. induced) CAMZYOS is only approved for patients 18 and older. You will not be able to get CAMZYOS at a local pharmacy. Click here to learn about Program Terms, Conditions, and Eligibility Criteria. Camzyos is part of the Cardiac Myosin Inhibitors class and treats Cardiomyopathy. While Taking CAMZYOS 6. 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. I can stop future marketing communications and use of my information by calling 1-877-274-0626. If so, when and where was the cardiologist located? 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 . The safety of Camzyos was evaluated in EXPLORER-HCM, a Phase 3, double-blind, randomized, placebo-controlled trial [see Clinical Studies (14)]. 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. Take CAMZYOS exactly as your healthcare provider tells you to take it. Use of my information will be governed by the BMS Privacy Policy. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS. Keep CAMZYOS and all medicines out of the reach of children. Your healthcare provider may change your dose, temporarily stop, or permanently stop your treatment with CAMZYOS if you have certain side effects. CAMZYOS reduces . The average baseline score was 5 for patients starting the trial. 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). Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Before you take CAMZYOS, you must enroll in the CAMZYOS REMS Program. After activation, you can opt out at any time by texting, Data obtained from you in connection with your registration for, and use of, this service may include your phone number and related carrier information. Call 855-CAMZYOS (855-226-9967) to learn more. To be eligible for the Free 35-Day Trial Offer for CAMZYOS: BY USING THIS OFFER, PATIENT AND PHARMACIST UNDERSTAND AND AGREE TO COMPLY WITH THESE ELIGIBILITY REQUIREMENTS AND TERMS OF USE. The risk of heart failure is also increased when CAMZYOS is taken with certain other medications. CAMZYOS can only be dispensed by a certified pharmacy that participates in the CAMZYOS REMS Program. By clicking the Download Free eBook button, you accept the terms and conditions and acknowledge that your data will be used as described in the Oracle privacy policy Patients, pharmacists, and healthcare providers must report the receipt of co-pay assistance benefits as may be required by patients insurance provider, This offer is not valid with any other program, discount, or incentive involving a BMS medication eligible for this Program, Offer valid only in the United States and United States territories. Talk to your healthcare provider about how to enroll in the CAMZYOS REMS Program. You may also report your pregnancy by calling Bristol Myers Squibb at. Patients, pharmacists, and prescribers cannot seek reimbursement for the Free 35-Day Trial of CAMZYOS from health insurance or any third party, including state or federally funded programs. You may also report your pregnancy by calling Bristol Myers Squibb at. Talk to your healthcare provider about the right dose for you. For more information, please see the U.S. Full Prescribing Information, including. SARS-CoV-2 mutations: The catalyst for a Covid-19 endemic? Consent and Preference Management Solution for Healthcare Providers, Thank you for subscribing to Clinical Trials Arena, Hard data and deep insights on clinical trials strategy & operations, Receive our newsletter - data, insights and analysis delivered to you. More improvement=improved pVO2 by at least 3.0 mL/kg/min. Void where prohibited by law, taxed, or restricted, The Program benefits are not transferable, This Program is not conditioned on any past, present, or future purchase, Upon registration, you will receive a confirmation text message. Around 27% and 6% of the patients treated with Camzyos complained of dizziness and syncope respectively, while 18% and 6% of those in the placebo group reported the same. 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 . A 30-week clinical study of 251 people compared two groups of adults with symptomatic obstructive HCM. CAMZYOS may improve your symptoms and your ability to be active. Class IV patients have severe limitations and complain of symptoms even while resting. What are the serious side effects of CAMZYOS? Camzyos is specifically indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. 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. 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. on your mobile device. You may be eligible for your first months prescription free. The therapy works by moving the myosins to an energy-sparing, super-relaxed state. The drug will, however, eventually face competition with the market launch of Cytokinetics aficamten, another myosin inhibitor that also targets obstructive HCM. Camzyos is an allosteric and reversible inhibitor selective for cardiac myosin. Camzyos capsules are administered orally once daily. Talk to your healthcare provider about the best way to feed your baby if you take CAMZYOS. This reduces the number of myosin-actin cross-bridges that form. The drug was developed by US-based biopharmaceutical company Bristol-Myers Squibb (BMS) and is distributed by its wholly-owned subsidiary, MyoKardia. Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure. BMY earnings call for the period ending September 30, 2022. Class II patients experience mild symptoms such as mild shortness of breath and/or angina pain and slight limitation during ordinary activities in daily life. The study first looked at how many people experienced either: Some improvement in their ability to be active and an improvement in their symptoms, More improvement in their ability to be active and no worsening of their symptoms. How was this measured? This means the heart isn't pumping blood effectively. 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