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Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
ABOUT ORGOVYX
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
HERO DIAGRAM
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
ABOUT ORGOVYX
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
ORAL DOSING
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).
Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).

References: 1. ORGOVYX (relugolix) [prescribing information]. Brisbane, CA: Sumitomo Pharma America; 2023. 2. Shore ND, Saad F, Cookson MS, et al. Oral relugolix for androgen-deprivation therapy in advanced prostate cancer. N Engl J Med. 2020;382(23):2187-2196 and supplementary material, available online. 3. Shore ND, Saad F, Cookson MS, et al. HERO phase 3 trial: relugolix, an oral GnRH receptor antagonist, versus leuprolide acetate for advanced prostate cancer. Presented at: American Society of Clinical Oncology Virtual Scientific Program; May 29-June 2, 2020; virtual. Abstract 5602. 4. Reyes C, Groshel C, Given R. Androgen deprivation therapy. In: Trabulsi EJ, Lallas CD, Lizardi-Calvaresi AE, eds. Chemotherapy and Immunotherapy in Urologic Oncology: A Guide for the Advanced Practice Provider. Springer International Publishing; 2021:77-92. 5. US Food and Drug Administration. FDA approves first oral hormone therapy for treating advanced prostate cancer. December 18, 2020. Accessed January 13, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-hormone-therapy-treating-advanced-prostate-cancer 6. Higano CS, Hafron J. Adherence with oral anticancer therapies: clinical trial vs real-world experiences with a focus on prostate cancer. J Urol. 2023;209(3):485-493. doi:10.1097/JU.0000000000003081 7. Fleshner NE, Alibhai SMH, Connelly KA, et al. Adherence to oral hormonal therapy in advanced prostate cancer: a scoping review. Ther Adv Med Oncol. 2023;15:1-22. doi:10.1177/17588359231152845 8. Lowrance WT, Breau RH, Chou R, et al. Advanced prostate cancer: AUA/ASTRO/SUO guideline part Il. J Urol. 2021;205(1):22-29. doi:10.1097/JU.0000000000001376 9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed November 14, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 10. Lowrance WT, Breau RH, Chou R, et al. Advanced prostate cancer: AUA/ASTRO/SUO guideline part I. J Urol. 2021;205(1):14-21. doi:10.1097/JU.0000000000001375 11. Crawford ED, Heidenreich A, Lawrentschuk N, et al. Androgen-targeted therapy in men with prostate cancer: evolving practice and future considerations. Prostate Cancer Prostatic Dis. 2019;22(1):24-38. doi:10.1038/s41391-018-0079-0 12. Data on file. Sumitomo Pharma America. 13. Moul JW. The evolving definition of advanced prostate cancer. Rev Urol. 2004;6(suppl 8):S10-S17.

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Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).

INDICATION

ORGOVYX® (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.

IMPORTANT SAFETY INFORMATION

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.

Please see Important Safety Information throughout and full Prescribing Information for ORGOVYX (relugolix).