camzyos rems requirements

NOTE: This portal cannot be opened in Internet Explorer (IE) or the legacy version of Microsoft Edge available before 2020. CAMZYOS (mavacamten) Echocardiogram Co-Pay Assistance Program Terms & Conditions. 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. The objectives of the CAMZYOS REMS are to: CAMZYOS is a cardiac myosin inhibitor 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. Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. CAMZYOS may improve your symptoms and your ability to be active. Echocardiogram assessments of left ventricular ejection fraction LVEF are required before and during treatment. A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the US Food and Drug Administration (FDA) can require for certain medicines to ensure they are used safely. 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%). using the vertical display Initiation of CAMZYOS in patients with LVEF <55% is not recommended. You will not be able to prescribe CAMZYOS without completing your certification in the CAMZYOS REMS. Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect the exposures of CAMZYOS. Concomitant use of CAMZYOS may decrease exposures of ethinyl estradiol and progestin, which may lead to contraceptive failure or an increase in breakthrough bleeding. To enroll in the CAMZYOS REMS and receive CAMZYOS, you must: Before taking CAMZYOS: 1. 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. Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in the REMS . In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. 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. Inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate (non-bovine), mannitol, and silicon dioxide. This site is intended for US residents only. As part of the REMS, your healthcare provider will discuss these interactions with CAMZYOS, including examples of which over-the-counter medicines and supplements to avoid. CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program. Advise females of reproductive potential to use effective contraception until 4 months after the last dose. You can also copy and paste the link into a different browser. What are the serious side effects of CAMZYOS? Monitoring requirements with CAMZYOS include: Set reminders for your echocardiograms on your smartphone or calendar. 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. on your mobile device. It is required by the US Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. CAMZYOS and the CAMZYOS and MyCAMZYOS logos are trademarks of MyoKardia, Inc. Echocardiogram assessments of LVEF are required prior to and during treatment. Take over-the-counter medications such as omeprazole (for example, Prilosec), esomeprazole (for example, Nexium), or cimetidine (for example, Tagamet). Receive and review the Patient Brochure. If needed, complete and submit a letter of medical necessity and a prior authorization form. Avoid concomitant use of CAMZYOS with disopyramide in combination with verapamil or diltiazem. Here are some things you can expect as you consider and start treatment. Initial and subsequent prescriptions for CAMZYOS must be written by the certified healthcare provider. At Week 38, following an 8week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. For more information and additional patient resources, visit camzyos.com/patient-support. CAMZYOS is a prescription medicine used to treat: adults with symptomatic obstructive h ypertrophic c ardio m yopathy (obstructive HCM). Prescribers must be certified by enrolling in the REMS Program. Also, be sure to tell your doctor if you are taking medicines to treat your obstructive HCM disease, Tell your doctor if you are pregnant or breastfeeding, or if you plan to become pregnant or breastfeed, Tell your doctor what form of birth control you may be using, Tell your doctor if you are developing an infection, Your CAMZYOS prescription will be sent to a, When you receive your medication, you will work with your doctor to schedule, Do not stop or change the dose of a medicine or start a new medicine without telling your healthcare provider, Do not change your dose of CAMZYOS without talking to your doctor first, Swallow the capsule whole without breaking, opening, or chewing it, If you miss a dose of CAMZYOS, take it as soon as possible and take your next dose at your regular time the next day. Discuss with your healthcare provider whether treatment with CAMZYOS is right for you. irregular heartbeat. Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. using the vertical display CAMZYOS [package insert]. Call your doctor for medical advice about side effects. Advise patients of the potential for drug interactions, including with over the counter medications (such as omeprazole, esomeprazole, or cimetidine). 2022 MyoKardia, Inc., a Bristol-Myers Squibb company. CAMZYOS may reduce the effectiveness of combined hormonal contraceptives (CHCs). 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. Inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate (non-bovine), mannitol, and silicon dioxide. The portal can be opened in the version of Microsoft Edge available in January 2020. using the vertical display 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. WARNING: RISK OF HEART FAILURE CAMZYOS may cause serious side effects, including heart failure. Camzyos (mavacamten) Capsules is a prescription medicine used to treat the symptoms of Obstructive Hypertrophic Cardiomyopathy. Each capsule is marked with the word MAVA and the number of milligrams (mg) it contains. 1-800-721-5072 or www.bms.com. All materials created or disseminated by the REMS TA Center, including the contents of this Website, should not be presumed to reflect the positions or policies of the U.S . are breastfeeding or plan to breastfeed. 2. Do not break, open, or chew the capsule. Do not initiate treatment in patients with LVEF <55% 1 Receive and review the Patient Brochure. If you have questions about the CAMZYOS REMS program, ask your healthcare provider, visit www.CAMZYOSREMS.com or call 1-833-628-7367. Your healthcare provider may change your dose, temporarily stop, or permanently stop your treatment with CAMZYOS if you have certain side effects. Advise females of reproductive potential to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. Due to the risk of heart failure due to systolic dysfunction, CAMZYOS is only available through a restricted program called the CAMZYOS REMS. This site is intended for U.S. Healthcare Professionals only. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS. *Prescribing Physician, Healthcare Facilities, Pharmacies and Patients must enroll into the Risk Evaluation and Mitigation Strategy (REMS) Program prior to initiating the patient on treatment with (Camzyos). Patients must enroll in the REMS Program and comply. Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in the REMS Program. in the CAMZYOS REMS in Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs. CAMZYOS is a capsule that should be taken at the same time once a day. Applicable drugs: Camzyos (mavacamten) Capsule More information please phone: 855-226-9967 Visit Website Have the authorized representative do the following: A.Complete the CAMZYOS REMS training program, which includes reviewing the following materials: Education Program for Healthcare Providers and Pharmacies, B.Successfully complete the Pharmacy Authorized Representative Knowledge Assessment and submit it to the REMS, C.Enroll in the CAMZYOS REMS on behalf of the pharmacy by completing the Pharmacy Enrollment Form and submitting it to the REMS, D.Train all relevant staff involved in dispensing CAMZYOS using the Program Overview and the Education Program for Healthcare Providers and Pharmacies, A.Counsel the patient on drug-drug interactions and review all prescription and nonprescription medications and supplements with the patient. 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. Camzyos is only available through a restricted program called the Camzyos Risk Evaluation and Mitigation Strategy Program and can only be dispensed by certified pharmacies that participate in the Camzyos REMS Program. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for CAMZYOS and any potential adverse effects on the breastfed child from CAMZYOS or from the underlying maternal condition. Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in the REMS Program. 2022 MyoKardia, Inc., a Bristol-Myers Squibb company. Camzyos helps heart muscle fibers relax more in between beats, allowing more blood entering the ventricles to be pumped out when they contract helping to resolve symptoms. Camzyos belongs to a class of drugs called Cardiac Myosin Inhibitors. 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. Females and Males of Reproductive Potential. on your mobile device. Please see US Full Prescribing Information, including Boxed WARNING and Medication Guide. Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in . Healthcare providers can help patients enroll and have them complete and sign the MyCAMZYOS Enrollment Form while in the office. You may also report your pregnancy by calling Bristol Myers Squibb at Store CAMZYOS capsules between 68F-77F (20C-25C). Camzyos is only available through a restricted program called the Camzyos REMS Program because of the risk of heart failure due to systolic dysfunction. CAMZYOS and other medicines may affect each other, causing side effects. Talk to your healthcare provider about finding a certified pharmacy. After you complete the form below, you can choose to download a PDF or save it directly to your contacts. Dispense no more than a 35-day supply of CAMZYOS. The Program includes medical benefit offer for out-of-pocket costs for required echocardiogram assessments where the full cost is not covered by the patients insurance, Patients are not eligible if they have medical 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, or are residents of Massachusetts, Minnesota, or Rhode Island. CAMZYOS has a REMS because of the risk of heart failure due to systolic dysfunction. unusual tiredness or weakness. 1 See how CAMZYOS works Decreasing the number of excess myosin-actin cross-bridges: Reduced dynamic LVOT obstruction1 Improved cardiac You can only get CAMZYOS from a certified pharmacy that is part of the CAMZYOS REMS program. Talk to your healthcare provider for more information about echos and your echo schedule. Based on your echocardiogram results, your doctor may increase, decrease, or keep your dose the sameor temporarily pause or discontinue your treatment. Camzyos will only be prescribed through a restricted program called the Camzyos Risk Evaluation and Mitigation Strategy (REMS). You can also copy and paste the link into a different browser. It is not known if Camzyos is safe and effective in children. If you take too much CAMZYOS, call your healthcare provider or go to the nearest hospital emergency room right away. Due to the risk of heart failure due to systolic dysfunction, CAMZYOS is only available Your healthcare provider can give you information on how to find a certified pharmacy. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations. The presence of CAMZYOS in human or animal milk, the drugs effects on the breastfed infant, or the effects on milk production are unknown. Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in the REMS Program. Making an appointment to see your doctor? 2022 MyoKardia, Inc., a Bristol-Myers Squibb company. This data may be used to administer this Program and to provide Program benefits such as information about your prescription, refill reminders, as well as program updates and alerts sent directly to your device, Participants may receive no more than 5 messages during the course of this Program. *Certified healthcare providers may designate a member of their staff who is a licensed medical This card can be printed out or saved directly to your device for easy access. 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 Confirm absence of pregnancy in females of reproductive potential prior to initiation of CAMZYOS. The most common adverse events reported with Camzyos were dizziness (27%) and syncope (6%). 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. Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in the REMS Program. Pharmacies must be certified The link is currently not available. Your doctor will provide you with a copy of the brochure. CAMZYOS is only available through a restricted program called the CAMZYOS REMS Program because of the risk of heart failure due to systolic dysfunction. You should discuss the: Get an echocardiogram to see if you are eligible for treatment with CAMZYOS. 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. Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure. 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. Dedicated Nurse Navigators are available to provide information and answer questions for patients on CAMZYOS. using the horizontal display 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. Camzyos may cause serious side effects including hives, difficulty breathing, swelling of your face/lips/tongue/throat, fainting, and reduced left . The most common side effects of CAMZYOS include dizziness and fainting (syncope). Patients must enroll in the REMS Program and comply with . order to receive CAMZYOS. using the vertical display trouble breathing. Also, there will be a screening for drug interactions as Camzyos may interact with . Closely monitor when CAMZYOS is used in combination with CYP3A4, CYP2C19, or CYP2C9 substrates where decreases in the plasma concentration of these drugs may reduce their activity. CAMZYOS may improve your symptoms and your ability to be active. Patients must enroll in the REMS Program and comply with . If youre prescribed CAMZYOS, take it exactly as directed by your healthcare provider. using the horizontal display Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in the REMS . Complete the Patient Enrollment Form with your healthcare provider. CAMZYOS may harm your unborn baby. Discuss with your healthcare provider whether treatment with CAMZYOS is right for you. 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. 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 (mavacamten) is part of REMS because it can put you at risk for heart failure.All providers who prescribe Camzyos (mavacamten), pharmacies that dispense the medication, and . Inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate (non-bovine), mannitol, and silicon dioxide. Swallow the capsule whole. Patients must enroll in the REMS Program and comply with . Once certified, use the portal to manage REMS tasks and patients, and to enroll a REMS designee. 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. 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)]. BMS announced a list price of $89,500 for a year of treatment. CAMZYOS may cause fetal toxicity when administered to a pregnant female, based on animal studies. 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. professional to be a Designee. A pharmacy will not be able to dispense CAMZYOS without completing pharmacy certification in the CAMZYOS REMS. Camzyos may be used alone or with other medications. Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure. CAMZYOSTM (mavacamten) reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Patients must enroll in the REMS Program and comply with ongoing monitoring requirements. using the vertical display NOTE: This portal cannot be opened in Internet Explorer (IE) or the legacy version of Microsoft Edge available before 2020. The REMS program helps ensure safe use by lowering the risk of heart failure due to impaired heart muscle contraction. CAMZYOS REMS Program . This website is best viewed on your mobile device. In some patients, CAMZYOSTM can cause heart failure due to systolic dysfunction, when the heart is unable to pump enough blood to the body. 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. What doses of Camzyos are available? Missed or delayed appointments can lead to an interruption in your treatment. Numeric values and special characters are not allowed. For patients to receive. Keep CAMZYOS and all medicines out of the reach of children. You should use effective birth control (contraception) during treatment with CAMZYOS and for 4 months after your last dose of CAMZYOS. Advise females of reproductive potential about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy.

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