When prescribing CAMZYOS, note that echocardiograms are required1: Echocardiograms may also be needed after a change in the dose of CAMZYOS, a break in treatment, and/or after starting certain medicines that are known to affect CAMZYOS.1. Patients must enroll in the REMS Program and comply with . You will not be able to get CAMZYOS at a local pharmacy. on your tablet device. Camzyos may cause serious side effects including hives, difficulty breathing, swelling of your face/lips/tongue/throat, fainting, and reduced left . 2022 MyoKardia, Inc., a Bristol-Myers Squibb company. Online OR by printing and faxing to 833-299-9539 The CAMZYOS REMS will send confirmation of your enrollment in the CAMZYOS REMS. Please enter the name of your cardiologist. Do not break, open, or chew the capsule. In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Advise patients to inform their healthcare provider of all concomitant products prior to and during CAMZYOS treatment. NOTE: This portal cannot be opened in Internet Explorer (IE) or the legacy version of Microsoft Edge available before 2020. Dedicated Nurse Navigators are available to provide information and answer questions for patients on CAMZYOS. The REMS TA Center is operated by Synergy Enterprises, Inc. under Contract #GS-00F-115CA awarded by the U.S. Department of Education, Office of Safe and Supportive Schools. required by the FDA to ensure the safe use of CAMZYOS. Notable requirements of the Camzyos REMS Program include the following: Prescribers must be certified by enrolling in the REMS Program. CAMZYOS is only available through a restricted program called the CAMZYOS REMS Program because of the risk of heart failure due to systolic dysfunction [see Warnings and Precautions (5.1, 5.2)]. Swallow the capsule whole. CAMZYOS may harm your unborn baby. CAMZYOSTM (mavacamten) reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. The most common side effects of CAMZYOS include dizziness and fainting (syncope). CAMZYOS comes in immediate release capsules, containing 2.5, 5, 10, or 15 mg of mavacamten. Please see additional Important Safety Information, . In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS. Patients who experience a serious intercurrent illness (e.g., serious infection) or arrhythmia (e.g., atrial fibrillation or other uncontrolled tachyarrhythmia) are at greater risk of developing systolic dysfunction and heart failure. (FDA) to ensure that the benefits of a drug outweigh its risks. To enroll in the CAMZYOS REMS and receive CAMZYOS, you must: Before taking CAMZYOS: 1. Your healthcare provider will do a pregnancy test before you start treatment with CAMZYOS. Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in the REMS Program. Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in the REMS . This site is intended for US residents only. Your healthcare provider can give you information on how to find a certified pharmacy. irregular heartbeat. through a restricted program called the CAMZYOS REMS. 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. Designate an authorized representative to complete the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy. You can also copy and paste the link into a different browser. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. The most common adverse events reported with Camzyos were dizziness (27%) and syncope (6%). Effects on Systolic Function 1-800-721-5072 or www.bms.com. Camzyos also has a Risk Evaluation and Mitigation Strategy (REMS) program. 1 See how CAMZYOS works Decreasing the number of excess myosin-actin cross-bridges: Reduced dynamic LVOT obstruction1 Improved cardiac Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in the REMS Program. on your mobile device. The Designee can perform REMS activities in the CAMZYOS REMS. in the CAMZYOS REMS in Any time the authorized representative changes, the new authorized representative must: A.Successfully complete the Pharmacy Authorized Representative Knowledge Assessment, B.Complete and submit the Pharmacy Enrollment Form to the CAMZYOS REMS to re-certify the pharmacy to dispense. 5.3. trouble breathing. The set of REMS requirements were designed to make sure all patients receive special monitoring during the period when a side effect is most likely to occur so it can be detected and treated:. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. Patients must enroll in the REMS Program and comply with . 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). 2022 MyoKardia, Inc., a Bristol-Myers Squibb company. You should discuss the: This site is intended for US residents only. You have successfully created your Patient Wallet Card. Look out for the following Initiate CAMZYOS at the recommended starting dose of 5 mg orally once daily in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Download REMS Patient Brochure 3: Discuss enrolling in MyCAMZYOS with patients The CAMZYOS REMS will send confirmation of the pharmacy's enrollment in the CAMZYOS REMS. Enroll patients in the CAMZYOS REMS program and educate them on the risk of heart failure due to systolic dysfunction and importance of regular cardiac monitoring during treatment. CAMZYOS is an inducer of CYP3A4, CYP2C9, and CYP2C19. 2022 MyoKardia, Inc., a Bristol-Myers Squibb company. Do not change your dose of CAMZYOS without talking to your healthcare provider first. What medicines should I discuss with my healthcare provider? 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. Patient is responsible for applicable taxes, if any. This means: What should I discuss with my healthcare provider before starting CAMZYOS? 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. Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in . No substitutions are permitted. If you do start on CAMZYOS, you must schedule regular echocardiogram appointments as instructed by your cardiologist. A REMS program is an FDA-required drug safety program. CAMZYOSTM (mavacamten) is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (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. CAMZYOS is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%). Missed or delayed appointments can lead to an interruption in your treatment. Camzyos may be used alone or with other medications. Making an appointment to see your doctor? CAMZYOS may increase the risk of heart failure due to systolic dysfunction; patients may experience heart failure at any time during treatment with 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 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. New or worsening arrhythmia, dyspnea, chest pain, fatigue, palpitations, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide (NT-proBNP) may be signs and symptoms of heart failure and should also prompt an evaluation of cardiac function. CAMZYOS is available in 2.5 mg, 5 mg, 10 mg, and 15 mg capsules. A pharmacy will not be able to dispense CAMZYOS without completing pharmacy certification in the CAMZYOS REMS. Notable requirements of the Camzyos REMS Program include the following: Prescribers must be certified by enrolling in the Camzyos REMS Program. Echocardiogram assessments of left ventricular ejection fraction LVEF are required before and during treatment. 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. 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. on your mobile device. Certified healthcare providers are responsible for all information entered and activities performed in the CAMZYOS REMS by the Designee. Do not stop or change the dose of a medicine or start a new medicine without telling your healthcare provider. If you do start on CAMZYOS, you must schedule regular echocardiogram appointments as instructed by your cardiologist. The portal can be opened in the version of Microsoft Edge available in January 2020. 5.3 CAMZYOS REMS Program . 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. Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs. If the pharmacy fails to comply with the CAMZYOS REMS requirements, the pharmacy will no longer be certified in the CAMZYOS REMS. Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in the REMS Program. CAMZYOS REMS Program . using the horizontal display Patients who have prescription insurance coverage through Medicare, Medicaid, or any other federal or state healthcare program are not eligible. 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. Review the REMS Patient Brochure to counsel appropriate patients on the risk of heart failure due to systolic dysfunction, the risk of drug-drug interactions with CYP2C19 and CYP3A4 inhibitors and inducers, and the need to inform their healthcare providers of all the prescription and nonprescription medications they take.1 Provide the patient with the REMS Patient Brochure and allow them the opportunity to review and ask questions prior to the initiation of therapy. Initiation of Camzyos in patients with LVEF less than 55% is not recommended. Please check back at a later time. It ensures that the benefits of a medication outweigh the risks. Tell your doctor about all the prescription or over-the-counter medicines, including vitamins and herbal supplements, you are taking, or plan to take. in the CAMZYOS REMS in CAMZYOS is only available through a restricted program called the CAMZYOS REMS Program because of the risk of heart failure due to systolic dysfunction. Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements, even if you dont take them every day. 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. This offer cannot be combined with any other offer, rebate, coupon, or free trial, This Program is not conditioned on any past, present, or future purchase, including additional doses, Bristol-Myers Squibb reserves the right to rescind, revoke, or amend this offer at any time without notice, This offer is available to commercially-insured patients being treated with CAMZYOS for an on-label indication. Trial drug, mean LVEF was 74 % ( 6 % ) and syncope ( 6 ) at baseline both. 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