Serious adverse reactions in ≥0.5% of patients included myocardial infarction (0.8%), acute kidney injury Serious adverse reactions occurred in 12% of patients receiving ORGOVYX. If PSA increases, serumĬoncentrations of testosterone should be measured. The therapeutic effect of ORGOVYX should be monitoredīy measuring serum concentrations of prostate-specific antigen (PSA) periodically. Results of diagnostic tests of the pituitary gonadotropic and gonadal functionsĬonducted during and after ORGOVYX may be affected. Laboratory Testing: Therapy with ORGOVYX results in suppression of the Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Discontinue ORGOVYX for severe hypersensitivity reactions and manage as clinically indicated.Įmbryo-Fetal Toxicity: The safety and efficacy of ORGOVYX have not been established in females. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue ORGOVYX and promptly seek medical care. Hypersensitivity reactions, including pharyngeal edema and other serious cases of angioedema, have been reported in post-marketing with ORGOVYX. Hypersensitivity: Angioedema was reported in 0.2% of patients treated with ORGOVYX in HERO. Consider periodic monitoring of electrocardiograms and electrolytes. Electrolyte abnormalities should be corrected. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. QT/QTc Interval Prolongation: Androgen deprivation therapy, such as ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or to any of the product IMPORTANT SAFETY INFORMATION & INDICATION Contraindication The ORGOVYX Copay Program is valid through December 31, 2024. Myovant Sciences reserves the right to revoke, rescind, or amend this offer without notice. Patient and participating pharmacists agree to report the receipt of Copay Program benefits to any insurer or other third party who pays for or reimburses any part of the prescription filled using the Card, as may be required by such insurer or third party. Patient and participating pharmacists agree not to seek reimbursement for all, or any part of the benefit received by the patient through this Copay Program. This offer is not conditioned on any past, present, or future purchase, including refills. This offer cannot be combined with any other coupon, free trial, discount, prescription savings card, or other offer. This Copay Program is void where prohibited by state law and on the date an AB generic equivalent for ORGOVYX becomes available. Patient must be a resident of the U.S., Puerto Rico, or U.S. Offer is not valid for cash-paying patients. The Copay Program is not valid for patients whose prescription claims are reimbursed, in whole or in part, by any state or federal government program, including, but not limited to, Medicaid, Medicare, Medigap, Department of Defense (DoD), Veterans Affairs (VA), TRICARE, Puerto Rico Government Insurance, or any state patient or pharmaceutical assistance program. This Copay Program may not be redeemed more than once per 21 days. After the annual maximum of $10,000 for ORGOVYX is reached, patient will be responsible for the remaining monthly out-of-pocket costs. With this Copay Program, eligible patients will pay as little as $10 per month, subject to a maximum of $10,000 per calendar year. *The ORGOVYX Copay Assistance Program (“Copay Program”) is for eligible patients with commercial prescription insurance for ORGOVYX. ORGOVYX COPAY ASSISTANCE PROGRAM: TERMS AND CONDITIONS
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