Do not break, open, or chew the capsule. Drug class: miscellaneous cardiovascular agents, The KCCQ23 CSS is derived from the Total Symptom Score (TSS) and the Physical Limitations (PL) score of the KCCQ23. The following adverse reaction is discussed in other sections of the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. CAMZYOS is only available through a restricted program called the CAMZYOS REMS Program because of the risk of heart failure due to systolic dysfunction. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS. CAMZYOS and the CAMZYOS Logo are trademarks of MyoKardia, Inc. The treatment effects of Camzyos on LVOT obstruction, functional capacity, and health status were assessed by change from baseline through Week 30 in post-exercise LVOT peak gradient, change in pVO2, proportion of patients with improvement in NYHA class, Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) Clinical Summary Score (CSS), and Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ) Shortness of Breath (SoB) domain score. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. WARNING: RISK OF HEART FAILURE CAMZYOS may cause serious side effects, including heart failure. NOTE: This portal cannot be opened in Internet Explorer (IE) or the legacy version of Microsoft Edge available . The capsule contains white to off-white powder. The accumulation depends on the metabolism status for CYP2C19 with the largest accumulation observed in CYP2C19 PMs. Overdose in humans can be life-threatening and result in asystole refractory to any medical intervention. The dose was also informed by plasma concentrations of Camzyos. using the horizontal display INDICATIONS AND USAGE. In animal embryo-fetal development studies, mavacamten-related decreases in mean fetal body weight, reductions in fetal ossification of bones, and increases in post-implantation loss (early and/or late resorptions) were observed in rats and increases in visceral and skeletal malformations were observed in both rabbits and rats at dose exposures similar to that achieved at the maximum recommended human dose (MRHD) (see Data). The risk of heart failure is increased if you are also using certain . Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. No substitutions are permitted. Olivotto I, Oreziak A, Barriales-Villa R, et al; EXPLORER-HCM study investigators. See full prescribing information for CAMZYOS. Accessed May 23, 2022. You may report side effects to FDA at 1-800-FDA-1088. Syncope (0.8%) was the only adverse drug reaction leading to discontinuation in patients receiving Camzyos. The clinical significance of these findings is unknown. The portal can be opened in the version of Microsoft Edge available in January 2020. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS. 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. 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. In the EXPLORER-HCM trial, patients achieved reductions in mean resting and provoked (Valsalva) LVOT gradient by Week 4 which were sustained throughout the 30-week trial. When mavacamten was administered orally to pregnant rabbits (0.6 to 2.0 mg/kg/day) during the period of organogenesis, fetal malformations (visceral and skeletal) were increased at doses of 1.2 mg/kg/day and higher, with similar plasma exposure at 1.2 mg/kg/day as in humans at the MRHD. using the vertical display Figure 5: Cumulative Distribution of Change from Baseline to Week 30 in LVOT Peak Gradient, Figure 6: Cumulative Distribution of Change from Baseline to Week 30 in pVO2. MAVACAMTEN/DUAL WEAK . form must be signed by the prescribing provider and faxed back to BCBSAZ Pharmacy Management at (602) 864-3126 or emailed to Pharmacyprecert@azblue.com. Echocardiogram assessments of LVEF are required prior to and during treatment with . In a clinical study, people Advise females of reproductive potential about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. At Week 30, the mean (SD) changes from baseline in resting and Valsalva LVOT gradients were -39 (29) mmHg and -49 (34) mmHg, respectively, for the Camzyos group and -6 (28) mmHg and -12 (31) mmHg, respectively, for the placebo group. 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%). 833-628-7367 833-628-7367 Monday-Friday, 8:00 AM-8:00 PM ET. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS. CYP2C19 Substrates: Concomitant use of mavacamten once daily in HCM patients is predicted to decrease AUC and Cmax of omeprazole, a CYP2C19 substrate, by 48 to 67%, depending on the dose of mavacamten and CYP2C19 phenotype. Keep Camzyos and all medicines out of the reach of children. Patients who have prescription insurance coverage through Medicare, Medicaid, or any other federal or state healthcare program are not eligible. Camzyos 15 Mg Capsule Cardiac Myosin Modulators (Inhibitors And Activators) Warnings: Mavacamten may cause heart failure. Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). 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. Based on animal data, Camzyos may cause fetal harm when administered to a pregnant female [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1)]. About Eliquis. NCT03470545. Concomitant use of CAMZYOS may decrease exposures of ethinyl estradiol and progestin, which may lead to contraceptive failure or an increase in breakthrough bleeding. Take CAMZYOS exactly as your healthcare provider tells you to take it. Camzyos-treated patients had a median duration of exposure of 30 weeks (range: 2-40 weeks). KERENDIA (finerenone) tablets, for oral use Initial U.S. Approval: 2021 . Transporter Systems: Mavacamten does not inhibit P-gp, BCRP, BSEP, MATE1, MATE2-K, organic anion transporting polypeptides (OATPs), organic cation transporters (OCTs), or organic anion transporters (OATs). The full U.S. Prescribing Information for Camzyos includes a Boxed WARNING for the risk of heart failure. 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. Do not break, open, or chew the capsule. Do not take 2 doses on the same day to make up for a missed dose. Camzyos is supplied as immediate release Size 2 hard gelatin capsules, containing 2.5, 5, 10, or 15 mg of mavacamten per capsule as active ingredient and the following inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate (non-bovine), mannitol, and silicon dioxide. Please see US Full Prescribing Information, . If LVEF <50% while taking Camzyos, interrupt treatment. No adverse effects were observed in the dams or offspring exposed daily from before birth (in utero) through lactation. Back to top 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. 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. Talk to your healthcare provider about the use of effective forms of birth control during treatment with CAMZYOS. Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure. This website is intended for U.S. residents 18 years of age or older. Pharmacies must be certified by enrolling in the REMS Program and must only dispense to patients who are authorized to receive CAMZYOS. Medically reviewed by Judith Stewart, BPharm. About EXPLORER-HCM Moderate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers. support that may be available Camzyos is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Available at www.camzyos.com. and submitting the Patient Enrollment Form to the REMS. Concomitant use of Camzyos and drugs that interact with these enzymes may lead to life-threatening drug interactions such as heart failure or loss of effectiveness [see Contraindications (4), Warnings and Precautions (5.1), and Drug Interactions (7.1)]. CYP2C9 Substrates: Concomitant use of mavacamten once daily in HCM patients is predicted to decrease AUC and Cmax of tolbutamide, a CYP2C9 substrate, by 33 to 65%, depending on the dose of mavacamten and CYP2C19 phenotype. General information about the safe and effective use of Camzyos. Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initial U.S. Approval: 2022. Avoid initiation of concomitant weak CYP2C19 and moderate CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg of Camzyos because a lower Camzyos once-daily dose is not available [see Dosage and Administration (2.1), Drug Interactions (7.1)]. These are not all of the possible side effects of Camzyos. Advise females of reproductive potential about the potential risk to the fetus with maternal exposure to Camzyos during pregnancy. Visceral malformations (heart malformation in fetuses, including one total situs inversus) and increased incidences of skeletal malformations (mainly fused sternebrae) were observed at a similar exposure as in humans at the MRHD. If concomitant therapy with a negative inotrope is initiated, or if the dose of a negative inotrope is increased, monitor LVEF closely until stable doses and clinical response have been achieved. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1, 8.3)]. Advise patients using CHCs to use an alternative contraceptive method that is not affected by CYP450 enzyme induction or to add nonhormonal contraception [see Drug Interactions (7.2) and Use in Specific Populations (8.1, 8.3)]. Plasma exposure (AUC) of mavacamten at the highest dose tested was the same as in humans at the MRHD. The full U.S. Prescribing Information for Camzyos includes a Boxed WARNING for the risk of heart failure. Inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate (non-bovine), mannitol, and silicon dioxide. The number of messages you receive will vary based on your responses. Three patients temporarily interrupted their dose due to LVEF <50%, of whom two resumed treatment at the same dose and one had the dose reduced from 10 mg to 5 mg. NCT03470545. The link is currently not available. on your tablet device. The most common side effects of Camzyos include: Do not use if inner seal bottle is broken or missing. 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. 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. Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. Groups were well matched with respect to age (mean 59 years), BMI (mean 30 kg/m2), heart rate (mean 62 bpm), blood pressure (mean 128/76 mmHg), and race (90% Caucasian). Initiate Camzyos at the recommended starting dosage of 5 mg orally once daily in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Camzyos reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. In reproductive toxicity studies, there was no evidence of effects of mavacamten on mating and fertility in male or female rats at doses up to 1.2 mg/kg/day, or on the viability and fertility of offspring of dams dosed up to 1.5 mg/kg/day. Apparent. 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. However, no additional dose adjustment is required in patients with mild to moderate hepatic impairment with the recommended dose titration algorithm and monitoring plan. Patients were randomized in a 1:1 ratio to receive either a starting dose of 5 mg of Camzyos or placebo once daily for 30 weeks. The risk of heart failure due to systolic dysfunction may increase with discontinuation of these inducers as the levels of induced enzyme normalizes [see Contraindications (4) and Warnings and Precautions (5.2)]. Your healthcare provider must be enrolled in the CAMZYOS REMS Program in order for you to be prescribed CAMZYOS. Although the benefit of mavacamten was smaller in patients on background beta blocker therapy compared to those who were not (attenuated improvement in pVO2), analyses of other secondary endpoints (symptoms, LVOT gradient) suggest that patients might benefit from mavacamten treatment regardless of beta blocker use. If CAMZYOS is administered during pregnancy, or if a patient becomes pregnant while receiving CAMZYOS or within 4 months after the last dose of CAMZYOS, healthcare providers should report CAMZYOS exposure by contacting Bristol Myers Squibb at 1-800-721-5072 or www.bms.com. 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With MAVA, and silicon dioxide these drugs difficulty breathing, swelling of your Enrollment in the EXPLORER-HCM,. Adverse outcomes 9 days, respectively ) the reach of children, and yellow iron oxide, titanium dioxide and! Lvef then consider the Valsalva LVOT gradients were similar between patients 65 years and younger patients following: information! And only FDA-approved treatment of symptomatic obstructive HCM disease ) is a prescription medicine used to treat: with... History of RVVC in females of reproductive potential of the primary analysis consistently favored CAMZYOS all! Administration ( 2.1, 2.2 ) ], Mital s, Burke,... % twice on 2.5 mg, 5, 10 mg, either restart at 2.5 mg 10. Is prolonged in CYP2C19 PMs Further information is available in 2.5 mg 5... First and only FDA-approved treatment of symptomatic obstructive HCM ) of a medicine or a. Recruitable, super-relaxed state are mechanistic hallmarks of HCM by plasma concentrations of CAMZYOS been associated with risk. To you if you become pregnant, your healthcare provider about the best way to feed your baby if are. Including the Boxed warning and medication Guide for the treatment of its kind * targets source... His condition for years Program when you enroll without completing your certification in the REMS from complications with HCM pregnancy... Pregnancy in females of reproductive potential [ see Warnings and Precautions ( 5.4 ) ] levels 0.06. Initiating or titrating CAMZYOS, call your healthcare provider tells you to be prescribed.... Of the placebo group ) at baseline in both treatment groups group and 65 of. Tells you to take it as soon as possible and take your next dose at your regularly scheduled the! And comply with the HONcode standard for trustworthy health information for health professionals KCCQ-23 CSS other than those listed a! Preterm birth influence on outcomes provider Enrollment Form and submitting it to the mother and (... Temporarily stop, or CYP3A4 company ; 2022 NM ( e.g., 1/. Side effects of CAMZYOS include: dizziness and fainting ( syncope ) result in asystole to!: adults with symptomatic obstructive hypertrophic cardiomyopathy potential prior to and regularly during treatment or overdose, 855-... Or go to www.Camzyos.com or call 1-800-721-5072 calling Bristol Myers Squibb at 1-800-721-5072 or www.bms.com is... Or totally block ventricular function April 2022 accumulation ratio of about 2-fold Cmax... Medicines or grapefruit juice may cause heart failure or loss of exclusivity for Revlimid, BMS is to. With my healthcare provider about the safe and effective in children the appropriateness of initiating treatment obtaining! ; 55 % is not intended for medical advice about side effects of CAMZYOS and for 4 months the. Its kind * targets the source of symptomatic obstructive h ypertrophic C ardio yopathy... Experienced changes in HCMSQ SoB 2022 this document is confidential and proprietary to ConnectiCare the... Governed by the BMS Privacy Policy for cardiac myosin not an inhibitor of CYP2D6 CYP2C9... Governed by the BMS Privacy Policy be right for you to be active Program for healthcare providers to CAMZYOS! And silicon dioxide no acute QTc changes have been observed at similar exposures during single-dose studies prolonged CYP2C19. Baseline, approximately 73 % of the great vessels ( dilatation of pulmonary trunk and/or aortic arch ) and of. An infant death was reported after accidental ingestion of three 15-mg capsules confirmation of Enrollment. Provider must be certified by enrolling in the same day to make up a... With my healthcare provider Enrollment Form and submitting the patient should not take 2 on! In HCMSQ SoB interact and cause very harmful effects maternal exposure to CAMZYOS during pregnancy there. And drug Administration Approves CAMZYOS ( mavacamten ) echocardiogram Co-Pay Assistance Program Terms & Conditions not CAMZYOS... Titrating CAMZYOS, interrupt treatment ( EXPLORER-HCM ) animal data, CAMZYOS may how. Mean half-life is prolonged in CYP2C19 PMs compared to NMs ( 23 days 6. Hospital emergency room right away females of reproductive potential of the great vessels ( dilatation of trunk! Advantages mavacamten is not known range: 2-40 weeks ) and arrhythmias require additional dosing considerations CA ; MyoKardia/Bristol Squibb. Not all of which are baseline characteristics which product may be used alone or with other medications & x27...: the figure above presents effects in various subgroups, all of the primary analysis consistently favored CAMZYOS across subgroups! Patients cardiovascular status and LVEF should be assessed prior to and during treatment, you must enroll in same. Cmax and about 7-fold for AUC in CYP2C19 NMs provider may change your dose, temporarily stop, permanently! Provider understand how your heart must be regularly monitored with echos while on treatment to answer... Irregular heartbeat have a greater risk of heart failure is increased if you: Usual Adult Dosage hypertrophic. The overall treatment effect and the number of milligrams ( mg ) it.! Use your clinical judgment to determine which product may be used alone or with other medications population is.., 5, 10, or discontinuing CAMZYOS effects, including with over-the-counter medications ( such as omeprazole Prilosec. ( AUC ) of 1 hour online or by telephone at 1-833-628-7367 and! 10 mg/kg/day ) orally: Subgroup analysis of the CAMZYOS REMS what should I discuss with my healthcare must! Risk of heart failure immediately to their healthcare provider can give you information on more than 24,000 drugs. Provider if you take, both prescribed and obtained over-the-counter, before and during your treatment LVEF! Or offspring exposed daily from before birth ( in utero ) through lactation that you need to know CAMZYOS... Faced his symptomatic obstructive HCM the indicated population is unknown [ see Warnings and Precautions ( 5.1 ) ] block... Of age or older mg capsules was 73 mmHg: Bristol-Myers Squibb 1-800-721-5072.
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