PDF Moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors (4 CAMZYOS may improve your symptoms and your ability to be active. icons as you read: CAMZYOS is a prescription medicine used to treat: adults with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM). CAMZYOS (mavacamten) REMS Program CAMZYOS (mavacamten) Co-Pay Assistance Program Terms & Conditions, Eligibility Requirements and Program Benefits, CAMZYOS (mavacamten) Bridge Program Terms & Conditions, CAMZYOS (mavacamten) Free 35-Day Trial Offer Program Terms & Conditions. Take it as soon as possible and take your next dose at your regularly scheduled time the next day. Tell your healthcare provider about the medicines you take, both prescribed and obtained over-the-counter, before and during treatment with CAMZYOS. If a coverage determination is delayed for twenty (20) calendar days or more, the patient will be provided CAMZYOS at no cost until coverage is received, a prior authorization is denied and not appealed, or for one (1) year, whichever is earlier, An appeal of any prior authorization denial must be made within 60 days or as per payer guidelines to remain in the Program, Patients continuing into the following year will be re-verified for eligibility in January. What are the serious side effects of CAMZYOS? 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. A poster presentation surrounding the analysis of pooled safety data from five clinical trials of mavacamten treatment in patients with obstructive and nonobstructive hypertrophic cardiomyopathy An oral presentation, sponsored by the Bristol Myers Squibb-Pfizer Alliance, on racial disparities and . CAMZYOS and the CAMZYOS and MyCAMZYOS logos are trademarks of MyoKardia, Inc. No report of Depression is found in people who take Camzyos. Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure. Camzyos Prices, Coupons, Copay & Patient Assistance - Drugs.com These are not all of the possible side effects of CAMZYOS. The drug will, however, eventually face competition with the market launch of Cytokinetics aficamten, another myosin inhibitor that also targets obstructive HCM. CAMZYOS (mavacamten) Patient Site Talk to your healthcare provider about the best way to feed your baby during treatment withCAMZYOS. Camzyos Drug Interactions - Epocrates Before you take CAMZYOS, tell your healthcare provider about all of your medical conditions, including if you: 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. What the data showed: Of those taking CAMZYOS, 65% (80/123) improved by one or more NYHA class compared with 31% (40/128) of those taking placebo. It is created by eHealthMe based on reports the from the FDA, and is updated regularly. Each capsule is marked with the word MAVA and the number of milligrams (mg) it contains. Patients classified under class I do not show symptoms and can perform ordinary physical activities such as walking and climbing stairs without any limitation. Patients who have prescription insurance coverage through Medicare, Medicaid, or any other federal or state healthcare program are not eligible. FDA Update for the Week of Oct 17, 2022 Patient is responsible for applicable taxes, if any. CAMZYOS may improve your symptoms and your ability to be active. . ketoconazole levels, efficacy (hepatic metab. This is a summary of important information that you need to know about CAMZYOS. CAMZYOS (mavacamten) may cause serious side effects, including: Notably, one abstract from the CAMZYOS . The most common side effects of CAMZYOS include dizziness and fainting (syncope). Response times may vary in Puerto Rico. 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. 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, or a racing sensation in your heart (palpitations) or rapid weight gain. For patients whose insurance changes during the course of program participation and otherwise remain eligible, a new prior authorization must be submitted, Program reserves the right to re-verify patients insurance coverage at any point during the patients participation in the Program, No claim for reimbursement for product dispensed pursuant to this offer may be made to any third-party payer, This offer is not conditioned on any past, present, or future purchase, including refills, Valid only in the United States and United States territories, Bristol-Myers Squibb reserves the right to modify or discontinue this offer at any time without notice, Patients must not have previously filled a prescription for CAMZYOS, Patient must have a valid 35-day prescription for CAMZYOS for an on-label indication, Patients are residents of the United States or a US territory, Eligible patients with a valid 35-day prescription for CAMZYOS can receive a free 35-day supply of CAMZYOS. A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. The most common side effects of CAMZYOS include dizziness and fainting (syncope). CAMZYOS (mavacamten) MyCAMZYOS Access Support and Resources | Safety Now obstructive HCM patients can be prescribed Camzyos with a starting dose of 5mg once daily with subsequent doses with titration at 2.5mg, 5mg 10mg or 15mg once daily. Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure. Do not take 2 doses on the same day to make up for a missed dose. 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. Cardiomyopathy is a cardiovascular condition that affects the hearts ability to pump blood. About EXPLORER-HCM The EXPLORER-HCM Phase 3 trial was a double-blind, randomized, placebo-controlled, parallel group trial that enrolled a total of 251 adult patients with symptomatic (NYHA class II or III), obstructive hypertrophic cardiomyopathy. ET. Your healthcare provider may change your dose, temporarily stop, or permanently stop your treatment with CAMZYOS if you have certain side effects. Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. 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. 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. mavacamten + ketoconazole contraindicated during and up to 1wk after ketoconazole tx; if possible, avoid ketoconazole if mavacamten use in prior 2wk: combo may incr. If you have symptomatic obstructive HCM, ask your doctor if CAMZYOS may be right for you. CAMZYOSTM (mavacamten) is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure. Mavacamten. 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). Please check back at a later time. Do not change your dose of CAMZYOS without talking to your healthcare provider first. Keep this information in a safe place so you can refer to it before and during your treatment. In obstructive HCM, myosin and actin form too many connections with each other, causing the heart to contract too much, which can make it difficult for it to relax. HCM is one of four subtypes of the indication and is characterised by abnormally thick heart muscle. CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction [see Warnings and Precautions (5.1)]. Always take CAMZYOS exactly as your doctor tells you to. Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure. Each capsule is marked with the word MAVA and the number of milligrams (mg) it contains. The average baseline score was 71 for patients starting the trial. 3. CAMZYOS is an allosteric and reversible inhibitor selective for cardiac myosin. Take CAMZYOS exactly as your healthcare provider tells you to take it. 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 . Numeric values and special characters are not allowed. 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. A lower LVOT gradient means there is less obstruction in the heart. Heart failure is a serious condition that can lead to death. Data Reinforcing Impact of Bristol Myers Squibb Cardiovascular All fields are required unless otherwise noted. Heart failure, a condition where the heart cannot pump with enough force. Also be sure People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with CAMZYOS. PDF CAMZYOS Medication Guide - BMS Heart failure is a serious condition that can lead to death. HCM is a chronic, progressive disease that make it hard for the heart to pump blood. BMS may also store and use my information to contact me via mail, telephone, in electronic format or otherwise about products, treatment options, services, market research, clinical trials, and other information and offers that it believes to be of interest to me. CAMZYOSTM (mavacamten) is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Call your doctor for medical advice about side effects. CAMZYOSTM (mavacamten) is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Keep CAMZYOS and all medicines out of the reach of children. Swallow the capsule whole. Data Reinforcing Impact of Bristol Myers Squibb Cardiovascular The two treatment arms were assessed by comparing changes in the metrics from the baseline to week 30. Heart failure, a condition where the heart cannot pump with enough force. Take it as soon as possible and take your next dose at your regularly scheduled time the next day. 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. CAMZYOS is an allosteric and reversible inhibitor selective for cardiac myosin that helps to modulate the number of myosin heads in the off state. Before you take CAMZYOS, you must enroll in the CAMZYOS REMS Program. CAMZYOS is a prescription medicine used to treat: adults with symptomatic obstructive h ypertrophic c ardio m yopathy (obstructive HCM). 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. *Symptoms were measured using the New York Heart Association (NYHA) classification. 1 See how CAMZYOS works Decreasing the number of excess myosin-actin cross-bridges: Reduced dynamic LVOT obstruction1 Improved cardiac The number of messages you receive will vary based on your responses. If so, when and where was the cardiologist located? And 6% of people experienced fainting. 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. Before Camzyos, there had not been medications indicated for obstructive HCM and the disease was either managed with generic cardiovascular therapies or surgical interventions such as surgical ablation, surgical resection of part of the ventricle, or alcohol ablation. You will not be able to get CAMZYOS at a local pharmacy. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 16, 2023. Financial & Patient Support Resources | Rx CAMZYOS (mavacamten CAMZYOS (mavacamten) Echocardiogram Co-Pay Assistance Program Terms & Conditions. Your healthcare provider will do a pregnancy test before you start treatment with CAMZYOS. inhibited; hepatic metab. The medicine is distributed exclusively through a restricted programme under a risk evaluation and mitigation strategy (REMS), called the Camzyos REMS PROGRAM, due to the potential risk of heart failure it poses. So its not an issue of having to stop something or make a choice between two drugs., Mavacamten will probably be used as a supplement in the studies. For patients whose insurance changes during the course of program participation and otherwise remain eligible, a new prior authorization must be submitted, Program reserves the right to re-verify patients insurance coverage at any point during the patients participation in the Program, No claim for reimbursement for product dispensed pursuant to this offer may be made to any third-party payer, This offer is not conditioned on any past, present, or future purchase, including refills, Valid only in the United States and United States territories, Bristol-Myers Squibb reserves the right to modify or discontinue this offer at any time without notice, Patients must not have previously filled a prescription for CAMZYOS, Patient must have a valid 35-day prescription for CAMZYOS for an on-label indication, Patients are residents of the United States or a US territory, Eligible patients with a valid 35-day prescription for CAMZYOS can receive a free 35-day supply of CAMZYOS. CAMZYOS is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). This website is best viewed Amgen to Webcast Investor Call at Aha 2022 2022 MyoKardia, Inc., a Bristol-Myers Squibb company. Please see US Full Prescribing Information, including Boxed WARNING and Medication Guide. 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. Interventional (Clinical Trial) Actual Enrollment : 59 participants: Allocation: Randomized: Intervention Model: Parallel Assignment: Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment: Official Title: A Randomized, Double-blind, Placebo-controlled, Concentration-guided, Exploratory Study . Camzyos and Depression - a phase IV clinical study of FDA data CAMZYOS is a prescription medicine used to treat: adults with symptomatic obstructive h ypertrophic c ardio m yopathy (obstructive HCM). 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. Camzyos and Recurrent cystitis - a phase IV clinical study of FDA data For example, in [country redacted] and most of Europebecause of national health system restrictions, I would expect the drug to be less expensive than in the US because of course the government impacts heavily on the pricing And therefore, there would be restrictions for patients that meet the inclusion criteria for the Phase III trial, which means that probably, given 100 patients that I see in my clinic with obstruction, that would probably make up to 25% to 30%. 5.3 CAMZYOS REMS Program 5.4 Embryo-Fetal Toxicity 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 7 DRUG INTERACTIONS 7.1 Potential for Other Drugs to Affect Plasma Concentrations of CAMZYOS 7.2 Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs 7.3 Drugs That Reduce Cardiac Contractility 8 USE IN SPECIFIC POPULATIONS 8.1 . It is not known if CAMZYOS passes into your breast milk. CAMZYOS (mavacamten) Echocardiogram Co-Pay Assistance Program Terms & Conditions. You may unsubscribe from the Program at any time by texting, Compatible carriers include: AT&T, T-Mobile, If you accidentally unsubscribe, or your mobile number changes, you may re-enroll in the mobile program via the method by which you may have originally enrolled, Bristol Myers Squibb reserves the right to rescind, revoke, or amend the Program without notice. By redeeming this offer, the patient certifies that they have not previously filled a prescription for CAMZYOS, The Free 35-Day Trial for the specified prescription cannot be combined with any other rebate/coupon, free trial, or similar offer. If you have questions about the CAMZYOS REMS program, ask your healthcare provider, visit www.CAMZYOSREMS.com or call 1-833-628-7367. take over-the-counter medicines, including medications like omeprazole (for example, Prilosec, take other medicines to treat your obstructive HCM disease, take other medicines to treat your obstructive. Take CAMZYOS exactly as your healthcare provider tells you to take it. using the horizontal display Information collected on this form is for your use only and will not be saved or transmitted. CAMZYOS comes in immediate release capsules, containing 2.5, 5, 10, or 15 mg of mavacamten. Camzyos may improve your symptoms and your ability to be active. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS. 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. 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