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- Important Safety
Information - Indication
- Prescribing
Information - Patient
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ENROLLMENT FORMS
ORGOVYX Support Program Start Form
Start your patients off with a comprehensive start form with details and checklists for the Bridge Program, Reimbursement Services, Financial Assistance, and patient info and consent.
REIMBURSEMENT RESOURCES
Sample Letter of Medical Necessity Template
Sample Letter of Medical Necessity Checklist
Sample Letter of Appeals Template
Sample Letter of Appeals Checklist
Prior Authorization Considerations
EDUCATIONAL RESOURCES FOR HCPs
ORGOVYX Support Program HCP Brochure
In this brochure, you’ll find information to help your patients start treatment. From insurance support to ORGOVYX® (relugolix) educational resources, this brochure is packed with information your patients may find helpful.
ORGOVYX Dosing Card
This dosing card provides dosing information and important things to consider when administering ORGOVYX.
Medicare Part D Brochure
With this brochure, you can gain a deeper understanding of Medicare Part D and how it relates to your appropriate patients.
Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer
This HERO study contains information that is not included in the FDA-approved full Prescribing Information for ORGOVYX.
Author(s) of this article have received remuneration from Sumitomo Pharma America, formerly Myovant Sciences, Inc.
EDUCATIONAL RESOURCES FOR PATIENTS
ORGOVYX Patient Brochure
Take part in helping your adult patients make an informed choice about their advanced prostate cancer treatment with this patient-focused brochure describing ORGOVYX, how it works, possible side effects, and the importance of taking ORGOVYX as directed.
Treatment Tracker With Dosing Information
Provide your patients with a simple way to track their daily medication along with information about how to take ORGOVYX, what to do about missed doses, and other things to remember.
ORGOVYX Discussion Guide With FAQ
For many patients, office visits can be stressful, potentially leaving important questions unasked. Together, with this discussion guide, you and your patients can cover important topics, questions, and things to consider when choosing a treatment option.
IMPORTANT SAFETY INFORMATION & INDICATION
Contraindication
ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or to any of the product components.
Warnings and Precautions
QT/QTc Interval Prolongation: Androgen deprivation therapy, such as ORGOVYX may prolong the QT/QTc interval. 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. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.
Hypersensitivity: Angioedema was reported in 0.2% of patients treated with ORGOVYX in HERO. Hypersensitivity reactions, including pharyngeal edema and other serious cases of angioedema, have been reported in post-marketing with ORGOVYX. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue ORGOVYX and promptly seek medical care. Discontinue ORGOVYX for severe hypersensitivity reactions and manage as clinically indicated.
Embryo-Fetal Toxicity: The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX.
Laboratory Testing: Therapy with ORGOVYX results in suppression of the pituitary gonadal system. Results of diagnostic tests of the pituitary gonadotropic and gonadal functions conducted during and after ORGOVYX may be affected. The therapeutic effect of ORGOVYX should be monitored by measuring serum concentrations of prostate-specific antigen (PSA) periodically. If PSA increases, serum concentrations of testosterone should be measured.
Adverse Reactions
Serious adverse reactions occurred in 12% of patients receiving ORGOVYX. Serious adverse reactions in ≥0.5% of patients included myocardial infarction (0.8%), acute kidney injury (0.6%), arrhythmia (0.6%), hemorrhage (0.6%), and urinary tract infection (0.5%). Fatal adverse reactions occurred in 0.8% of patients receiving ORGOVYX including metastatic lung cancer (0.3%), myocardial infarction (0.3%), and acute kidney injury (0.2%). Fatal and non-fatal myocardial infarction and stroke were reported in 2.7% of patients receiving ORGOVYX.
Most common adverse reactions (≥10%) and laboratory abnormalities (≥15%) in patients receiving ORGOVYX were hot flush (54%), glucose increased (44%), triglycerides increased (35%), musculoskeletal pain (30%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), fatigue (26%), aspartate aminotransferase increased (18%), constipation (12%), and diarrhea (12%).
Drug Interactions
Co-administration of ORGOVYX with a P-gp inhibitor increases the area under the curve (AUC) and maximum concentration (Cmax) of ORGOVYX, which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions. Treatment with ORGOVYX may be interrupted for up to 2 weeks for a short course of treatment with certain P-gp inhibitors. If treatment with ORGOVYX is interrupted for more than 7 days, resume administration of ORGOVYX with a 360 mg loading dose on the first day, followed by 120 mg once daily.
Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases the AUC and Cmax of ORGOVYX, which may reduce the effects of ORGOVYX. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended ORGOVYX dose of 120 mg once daily.
INDICATION
ORGOVYX® (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.
Please see full Prescribing Information for ORGOVYX.
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