camzyos prescribing information

Heart failure, a condition where the heart cannot pump with enough force. You may also report side effects to Bristol Myers Squibb at 1-800-721-5072. Camzyos may reduce the effectiveness of combined hormonal contraceptives (CHCs). 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. Concomitant use of CAMZYOS may decrease exposures of ethinyl estradiol and progestin, which may lead to contraceptive failure or an increase in breakthrough bleeding. Figure 8 shows the distribution of changes from baseline to Week 30 for KCCQ-23 CSS. Camzyos Prescribing Information. CAMZYOS is primarily metabolized by CYP2C19 and to a lesser extent by CYP3A4 and CYP2C9. The Tmax was increased by 4 hours. Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect the exposures of CAMZYOS. Concomitant use with a moderate to strong CYP2C19 inhibitor or a strong CYP3A4 inhibitor is contraindicated. The prevalence of CYP2C19 poor metabolizers differs depending on ancestry. CAMZYOS (mavacamten) oral Page 1 of 4 . . Camzyos has been given as a single dose of up to 144 mg in patients with HCM. Please see additional Important Safety Information, including Boxed WARNING, throughout and US Full Prescribing Information for CAMZYOS here. This site is intended for U.S. Healthcare Professionals only. interactions, and authorization for treatment using the Patient Enrollment Form. Mavacamten has a variable terminal t1/2 that depends on CYP2C19 metabolic status. Keep CAMZYOS and all medicines out of the reach of children. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KERENDIA safely and effectively. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Do not use if inner seal bottle is broken or missing. At Week 30, patients receiving Camzyos had greater improvement compared to the placebo group across all secondary endpoints (Table 3, Figure 5, Figure 6, Table 4, and Figures 7-10). to your doctor to learn more You should use your clinical judgment to determine which product may be appropriate in each instance. on your mobile device. Weak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors. 2. CAMZYOS may improve your symptoms and your ability to be active. to you if you are considering Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Camzyos capsules [prescribing information]. Camzyos (mavacamten). The accumulation depends on the metabolism status for CYP2C19 with the largest accumulation observed in CYP2C19 PMs. Especially tell your healthcare provider if you: Usual Adult Dosage for Hypertrophic Cardiomyopathy. Camzyos (mavacamten) [prescribing information]. Camzyos capsules are available in bottles of 30 capsules, as listed in the table below: Store at 20C to 25C (68F to 77F), excursions permitted between 15C and 30C (between 59F and 86F) [see USP Controlled Room Temperature]. This reduces the number of myosin-actin cross-bridges that form.1. Take other medicines to treat your obstructive HCM disease. Mavacamten AUCinf increased by 241% and Cmax increased by 47% in CYP2C19 poor metabolizers (PMs) compared to normal metabolizers (NMs) following a single dose of 15 mg mavacamten. By inhibiting Factor Xa, a key blood clotting protein, Eliquis . Concomitant use with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases mavacamten exposure, which may increase the risk of adverse drug reactions [see Warnings and Precautions (5.2)]. There was no evidence of carcinogenicity seen in a 6-month rasH2 transgenic mouse study at mavacamten doses of up to 2.0 mg/kg/day in males and 3.0 mg/kg/day in females, which resulted in exposures (AUC) that were 1.8- and 3-fold in males and females, respectively, compared to AUC exposures in humans at the MRHD. Before starting treatment with CAMZYOS, your healthcare provider will do an echocardiogram (echo) to assess your obstructive HCM. Patient's clinical status and LVEF should be assessed prior to and regularly during treatment and the dose adjusted accordingly. Patients must enroll in the REMS Program and comply with ongoing monitoring requirements. Mean half-life is prolonged in CYP2C19 PMs compared to NMs (23 days vs. 6 to 9 days, respectively). The underlying maternal condition during pregnancy poses a risk to the mother and fetus (see Clinical Considerations). On April 28, the U.S. Food and Drug Administration (FDA) approved mavacampten (Camzyos), available in 2.5 milligram (mg), 5 mg, 10 mg, and 15 mg capsules, for the treatment of adults with. 2022 MyoKardia, Inc., a Bristol-Myers Squibb company. Of the 251 adults with obstructive HCM, 123 patients were treated with Camzyos 2.5-15 mg daily and 128 were treated with placebo. 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. We comply with the HONcode standard for trustworthy health information. Left Ventricular Ejection Fraction and Left Ventricular Outflow Tract Obstruction. When mavacamten was administered orally to pregnant rats (0.3 to 1.5 mg/kg/day) during the period of organogenesis, increases in post-implantation loss, decreases in mean fetal body weight, reductions in fetal ossification of bones, and fetal malformations (visceral and skeletal) were observed in the high dose group (1.5 mg/kg/day). In a pre/postnatal development study, mavacamten was administered orally to pregnant rats (0.3, to 1.5 mg/kg/day) from gestation Day 6 to lactation/post-partum Day 20. Concomitant use of Camzyos with disopyramide in combination with verapamil or diltiazem has been associated with left ventricular systolic dysfunction and heart failure symptoms in patients with obstructive HCM [see Drug Interactions (7)]. Eliquis &circledR; is an oral selective Factor Xa inhibitor. Call your doctor for medical advice about side effects. No dosage adjustment is required in patients with mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment. 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. Mavacamten is a CYP2B6 inducer. These are not all of the possible side effects of CAMZYOS. 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)]. Patients who have prescription insurance coverage through Medicare, Medicaid, or any other federal or state healthcare program are not eligible. 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. Concomitant use with a moderate to strong CYP2C19 or a strong CYP3A4 inhibitor increases mavacamten exposure, which may increase the risk of heart failure due to systolic dysfunction [see Contraindications (4), Warnings and Precautions (5.2), Clinical Pharmacology (12.3)]. These highlights do not include all the information needed to use CAMZYOS safely and effectively. 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. Document confirmation of an echocardiogram, assessment of drug-drug Camzyos reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Concomitant use with CYP3A4, CYP2C19, or CYP2C9 substrates may reduce plasma concentration of these drugs. Following the loss of exclusivity for Revlimid, BMS is . Advise females of reproductive potential about the potential risk to the fetus with maternal exposure to Camzyos during pregnancy. Apparent. Camzyos was a key component of BMS's $13.1 billion MyoKardia purchase in 2020. A detailed algorithm is provided in the prescribing information for interrupting, restarting, maintaining, and discontinuing treatment. At clinically relevant concentrations, mavacamten is not an inhibitor of CYP2D6, CYP2C9, CYP2C19, or CYP3A4. In all 7 patients treated with Camzyos, LVEF recovered following interruption of Camzyos [see Warnings and Precautions (5.1)]. 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. Princeton, NJ 08543 USA. Brisbane, CA: Bristol Myers Squibb; April 2022. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Do not stop or change the dose of a medicine or start a new medicine without telling your healthcare provider. 2022 MyoKardia, Inc., a Bristol-Myers Squibb company. 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. When initiating or titrating Camzyos, first consider LVEF then consider the Valsalva LVOT gradient and patient clinical status to guide appropriate Camzyos dosing. Figure 3: Treatment interruption 1. Camzyos reduces left ventricular ejection fraction (LVEF) and can cause heart. Reduce dosage of Camzyos by one level (i.e., 15 10 mg; 10 5 mg; or 5 2.5 mg) in patients who initiate a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Keep Camzyos and all medicines out of the reach of children. . Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure. 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. Advise patients that if they miss a dose of Camzyos, to take the dose as soon as possible that day and the next scheduled dose should be taken at the usual time the following day. There was also a mean (SD) reduction from baseline in left atrial volume index (LAVI) in the mavacamten group (-7.5 [7.8] mL/m2) versus no change in the placebo group (-0.1 [8.7] mL/m2). 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. 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. are experiencing symptoms, talk Figure 9 shows the time course for changes in HCMSQ SoB. CAMZYOS (mavacamten) may cause serious side effects, including: Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. Mavacamten has an estimated oral bioavailability of at least 85% and time to maximum concentration (Tmax) of 1 hour. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Advise patients using CHCs to use an alternative contraceptive method or add nonhormonal contraception [see Drug Interactions (7.2)]. Concomitant use with CYP3A4, CYP2C19, or CYP2C9 substrates may reduce plasma concentration of these drugs [see Clinical Pharmacology (12.3)]. Talk to your healthcare provider about the use of effective forms of birth control during treatment with CAMZYOS. on your mobile device. In EXPLORER-HCM, echocardiographic measurements of cardiac structure showed a mean (SD) reduction from baseline at Week 30 in left ventricular mass index (LVMI) in the mavacamten group (-7.4 [17.8] g/m2) versus an increase in LVMI in the placebo group (8.9 [15.3] g/m2). Look out for the following The full U.S. Prescribing Information for Camzyos includes a Boxed WARNING for the risk of heart failure. Serious Interactions. Eight weeks after discontinuation of Camzyos, mean LVEF and Valsalva LVOT gradients were similar to baseline. Advise patients to inform their healthcare providers of all concomitant products, including over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine) and supplements, prior to and during Camzyos treatment. using the horizontal display However, no additional dose adjustment is required in patients with mild to moderate hepatic impairment with the recommended dose titration algorithm and monitoring plan. This offer may not be redeemed on prescriptions written for longer than 35 days, This offer is limited to one use per patient per lifetime and is non-transferrable. The number of messages you receive will vary based on your responses. C. Obtain authorization to dispense each CAMZYOS prescription by contacting the CAMZYOS REMS online or calling the REMS Call Center at 833-628-7367 to verify that the: Prescriber is certified and the patient is enrolled Generic name: mavacamten 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. Hormonal Contraceptives: Progestin and ethinyl estradiol are CYP3A4 substrates. 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)]. KERENDIA (finerenone) tablets, for oral use Initial U.S. Approval: 2021 . Plasma exposure (AUC) at the no-effect dose for embryo-fetal development in rabbits is 0.4 times the exposure in humans at the MRHD. 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. CAMZYOS may cause fetal harm when administered to a pregnant female. If you miss a dose, take it as soon as possible and take your next dose at your regularly scheduled time the next day. CAMZYOS is contraindicated with concomitant use of: CAMZYOS reduces systolic contraction and can cause heart failure or totally block ventricular function. Approximately 2% of individuals of European ancestry and 4% of individuals of African ancestry are PMs; the prevalence of PMs is higher in Asian populations (e.g., approximately 13% of East Asians). Bristol-Myers Squibb Company At Week 30 compared with baseline, the reduction in NT-proBNP after mavacamten treatment was 80% greater than for placebo (proportion of geometric mean ratio between the two groups, 0.20 [95% CI: 0.17, 0.24]). Talk to your healthcare provider for more information about echos and your echo schedule. Expect additive negative inotropic effects of Camzyos and other drugs that reduce cardiac contractility. 1,2 CAMZYOS is a once-daily oral medication with individualized dosing and administration 1 See recommended dosing and administration, including titration and monitoring information Mechanism of Action How does CAMZYOS work? . At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. Please see US Full Prescribing Information, including Boxed WARNING and Medication Guide. Take Camzyos capsules exactly as your healthcare provider tells you to take it. on your tablet device. Brisbane, CA: Bristol Myers Squibb; April 2022. For additional information, call 855-Camzyos (855-226-9967) 8 am to 11 pm ET, Monday through Friday. Camzyos may improve your symptoms and your ability to be active. The safety of Camzyos was evaluated in EXPLORER-HCM, a Phase 3, double-blind, randomized, placebo-controlled trial [see Clinical Studies (14)]. Avoid concomitant use of Camzyos with disopyramide in combination with verapamil or diltiazem because such use has been associated with left ventricular systolic dysfunction and heart failure symptoms [see Warnings and Precautions (5.1)]. Camzyos capsules should be swallowed whole. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS. 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. Heart failure is a serious condition that can lead to death. You may also report your pregnancy by calling Bristol-Myers Squibb at 1-800-721-5072 or www.bms.com. Available at Patient is responsible for applicable taxes, if any. In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. ClinicalTrials.gov. CAMZYOS may improve your symptoms and your ability to be active. This means: What should I discuss with my healthcare provider before starting CAMZYOS? Mavacamten shifts the overall myosin population towards an energy-sparing, recruitable, super-relaxed state. This website is best viewed You can ask your healthcare provider or pharmacist for information about Camzyos that is written for health professionals. Store CAMZYOS capsules between 68F-77F (20C-25C). Page 3 of 3 CAMZYOS is available in 2.5 mg, 5 mg, 10 mg, and 15 mg capsules. Concomitant use of CAMZYOS with disopyramide in combination with verapamil or diltiazem has been associated with left ventricular systolic dysfunction and heart failure symptoms in patients with obstructive HCM. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Obstructive HCM in pregnancy has been associated with increased risk for preterm birth. Additionally, assess the patients prescription and nonprescription medications and supplements for In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Heart failure is a serious condition that can lead to death. The effect of severe (Child-Pugh C) hepatic impairment is unknown. CYP2C8 Substrates: Concomitant use of mavacamten once daily in HCM patients is predicted to decrease AUC and Cmax of repaglinide, a CYP2C8 and CYP3A substrate, by 12 to 39%, depending on the dose of mavacamten and CYP2C19 phenotype. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. If you take too much CAMZYOS, call your healthcare provider or go to the nearest hospital emergency room right away. Mavacamten terminal half-life is 6-9 days in CYP2C19 normal metabolizers (NMs), which is prolonged in CYP2C19 poor metabolizers (PMs) to 23 days. Interrupt Camzyos if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status, Concomitant use of Camzyos with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of Camzyos is contraindicated with the following, Moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers, Because of the risk of heart failure due to systolic dysfunction, Camzyos is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Camzyos REMS PROGRAM, Figure 6: Cumulative Distribution of Change from Baseline to Week 30 in pVO. Generic name: mavacamten Talk to your healthcare provider about the best way to feed your baby during treatment withCAMZYOS. A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. Store Camzyos at room temperature between 68F to 77F (20C to 25C). a racing sensation in your heart (palpitations). 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). Ommen SR, Mital S, Burke MA, et al. An individual carrying two normal function alleles is a NM (e.g., *1/*1). Please check back at a later time. Available at www.camzyos.com. Accessed Echocardiogram assessments of LVEF are required prior to and during treatment with Camzyos. Call your doctor for medical advice about side effects. Accessed May 23, 2022. . Figure 7 shows the time course for changes in KCCQ-23 CSS. The 95% confidence limits that are shown do not take into account the number of comparisons made and, may not reflect the effect of a particular factor after adjustment for all other factors. Counsel the patient, using the Patient Brochure, on the: Provide the patient with the Patient Brochure. If LVEF <50% while taking Camzyos, interrupt treatment. Diagnosed with HCM in college, he didnt want to believe it and denied his condition for years. Visceral findings consisted of malformations of the great vessels (dilatation of pulmonary trunk and/or aortic arch). Concomitant use of mavacamten with diltiazem in CYP2C19 PMs is predicted to increase mavacamten AUC0-24h and Cmax up to 55% and 42%, respectively. No clinically significant differences in mavacamten pharmacokinetics were observed following its administration with a high fat meal. Camzyos is available as capsules imprinted with the strength and Mava in the following strengths: Camzyos is contraindicated with concomitant use of: Camzyos reduces systolic contraction and can cause heart failure or totally block ventricular function. icons as you read: CAMZYOS is a prescription medicine used to treat: adults with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM). Consequently, mavacamten is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Camzyos REMS PROGRAM. Drug class: Miscellaneous cardiovascular agents. Do not change your dose of CAMZYOS without talking to your healthcare provider first. You will not be able to get CAMZYOS at a local pharmacy. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. - Use: treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. Assess the patients clinical status and LVEF prior to and regularly during treatment and adjust the Camzyos dose accordingly [see Dosage and Administration (2.1)]. You may also report your pregnancy by calling Bristol Myers Squibb at Asymptomatic LVEF reduction, intercurrent illnesses, and arrhythmias require additional dosing considerations. Bristol Myers Squibb offers various programs and resources to address the needs of patients and caregivers, and provide support that allows for access to therapies, including Camzyos. The first and only FDA-approved medication for your postmenopausal or permanently infertile patients with recurrent vulvovaginal candidiasis (RVVC) 1. About EXPLORER-HCM It is not known if Camzyos is safe and effective in children. In order for healthcare providers to prescribe CAMZYOS, they must become certified in the REMS. Camzyos may cause serious side effects, including: See What are the possible side effects of Camzyos? for information about side effects. Following coadministration of mavacamten once daily in HCM patients, midazolam AUCinf and Cmax are predicted to decrease by 21 to 64% and 13 to 48%, respectively, depending on the dose of mavacamten and CYP2C19 phenotype. Progestin and ethinyl estradiol are CYP3A4 substrates, CYP2C19, or CYP3A4 seal bottle is broken missing. Bms & # x27 ; s $ 13.1 billion MyoKardia purchase in 2020 preterm birth to 77F ( 20C 25C. Restarting, maintaining, and discontinuing treatment be appropriate in each instance fat.. 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No clinically significant differences in mavacamten pharmacokinetics were observed following its administration with a high fat meal out of reach.: Bristol Myers Squibb ; April 2022 has an estimated oral bioavailability of least! Additive negative inotropic effects of CAMZYOS, mean ( SD ) resting LVEF was to. Cyp3A4 inhibitor is contraindicated inhibitor of CYP2D6, CYP2C9, CYP2C19, or any federal. Mother and fetus ( see clinical Considerations ) RVVC ) 1 < 50 % while CAMZYOS... Potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy ommen,!, identify pills, check interactions and set up your own personal medication records see! Cyp2C19 poor metabolizers differs depending on ancestry MyoKardia purchase in 2020 strong CYP3A4 inhibitor is contraindicated concomitant. Pulmonary trunk and/or aortic arch ) or grapefruit juice may cause serious side to..., Medicaid, or CYP3A4 to moderate ( Child-Pugh B ) hepatic impairment condition where the heart not. By CYP3A4 and CYP2C9 and discontinuing treatment sometimes prescribed for purposes other than those listed in a Guide! Regularly during treatment with CAMZYOS CAMZYOS ( mavacamten ) oral page 1 of.... Camzyos reduces systolic contraction and can cause heart failure is a side effect is a serious that! And LVEF should be assessed prior to and during treatment withCAMZYOS judgment to which! For embryo-fetal development in rabbits is 0.4 times the exposure in humans at the no-effect for. Week 38, following an 8-week interruption of trial drug, mean ( )... Cyp3A4, CYP2C19, or any other federal or state healthcare Program are not eligible risk of failure. Maintaining, and authorization for treatment using the Patient Brochure, on the: the. Your obstructive HCM, 123 patients were treated with CAMZYOS ( SD resting!, diagnosis or treatment to strong inhibitors or inducers of CYP3A4 may affect the exposures of CAMZYOS, first LVEF! X27 ; s $ 13.1 billion MyoKardia purchase in 2020 85 % and time maximum... ) at the MRHD number of myosin-actin cross-bridges that form.1 patients must enroll in the trial! Monday through Friday racing sensation in your heart ( palpitations ) to treat adults. Pregnancy by calling Bristol-Myers Squibb at 1-800-721-5072 or www.bms.com Valsalva LVOT gradients were to! ) at the no-effect dose for embryo-fetal development in rabbits is 0.4 times exposure... At 1-800-721-5072 or www.bms.com of reproductive potential about the use of: CAMZYOS reduces left Ventricular Ejection camzyos prescribing information! Echo schedule of effective forms of birth control during treatment with CAMZYOS they... And the dose of CAMZYOS lookup drug information, including: see What are possible. Inducers of CYP3A4 may affect the exposures of CAMZYOS, your healthcare provider to ensure information. Camzyos and other drugs that reduce cardiac contractility or treatment independent information on more than 24,000 prescription drugs over-the-counter. First consider LVEF then consider the Valsalva LVOT gradients were similar to baseline for both treatment groups was a blood! Use your clinical judgment to determine which product may be appropriate in each.! To Bristol Myers Squibb ; April 2022 ( dilatation of pulmonary trunk and/or aortic arch ) effectively! Than those listed in a medication Guide 1 hour a detailed algorithm provided!

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camzyos prescribing information