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ORGOVYX is the only oral once-a-day GnRH receptor antagonist for advanced prostate cancer1,2
DIVE INTO
ORGOVYX
Clinical considerations
when choosing ORGOVYX
when choosing ORGOVYX
See how changes to
Medicare Part D
could impact your
patients
Medicare Part D
could impact your
patients
RECOMMENDED BY NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES®)4*
NCCN Guidelines® recommend relugolix (ORGOVYX) as an NCCN Category 2A treatment option for patients with advanced prostate cancer†
Some recommendations may fall outside of the ORGOVYX US Prescribing Information.
*The 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.4
†A Category 2A recommendation is based upon lower-level evidence and indicates there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.4
Testosterone
can be
controlled
Throughout
the dive
can be
controlled
Throughout
the dive
PRIMARY ENDPOINT
SUSTAINEDTESTOSTERONE SUPPRESSION TO <50 ng/dL.1
96.7%
(95% CI: 94.9-97.9) of men achieved and maintained testosterone suppression to <50 ng/dL from Day 29 through Week 48 with ORGOVYX (n=622)1
88.8% (95% CI: 84.6-91.8)‡ of men treated with leuprolide achieved and maintained testosterone suppression to <50 ng/dL from Day 29 through Week 481
HERO STUDY DESIGN
THE HERO STUDY was a multinational, randomized, open-label, phase 3 trial in 930 men with aPC. Key inclusion criteria included men with aPC defined as biochemical prostate-specific antigen (PSA) or clinical relapse following local primary intervention with curative intent, newly diagnosed castration-sensitive metastatic disease, or advanced localized disease unlikely to be cured by local primary intervention, requiring at least 1 year of ADT, ECOG 0/1. Patients were randomized 2:1 to receive ORGOVYX (360 mg on the first day followed by daily doses of 120 mg orally [n=622]) or leuprolide acetate (22.5 mg injection§) for 48 weeks.1,2,5
ADT=androgen deprivation therapy; aPC=advanced prostate cancer; CI=confidence interval; ECOG=Eastern Cooperative Oncology Group; GnRH=gonadotropin-releasing hormone; NCCN=National Comprehensive Cancer Network®.
‡The castration rate of the subgroup of patients receiving 22.5 mg leuprolide (n=264) was 88.0% (95% CI: 83.4%-91.4%).1
§11.25 mg in Japan and Taiwan per local guidelines subcutaneously every 3 months (n=308). 11.25 mg is a dosage regimen that is not recommended for aPC in the United States.1
Please see additional information about ORGOVYX throughout this website.
ESTABLISHED SAFETY
The most common adverse events during treatment with ORGOVYX (≥10%) in the study were hot flush, musculoskeletal pain, fatigue, constipation, and diarrhea.1
ESTABLISHED SAFETY
The most common adverse events during treatment with ORGOVYX (≥10%) in the study were hot flush, musculoskeletal pain, fatigue, constipation, and diarrhea.1
Review ORGOVYX safety data from the HERO study
Watch Dr Neal D. Shore and Dr Eleni Efstathiou
talk about ORGOVYX
Please see full Prescribing Information and Important Safety Information for ORGOVYX.
With over 690,000 prescriptions filled, consider ORGOVYX for
your patients with aPC1,3||
ORGOVYX NATIONAL COVERAGE
99 % of Medicare patients are covered for ORGOVYX3¶
93 % of commercial patients are covered for ORGOVYX3¶
SEE FORMULARY COVERAGE
IN YOUR AREA
IN YOUR AREA
||Based on internal demand data (specialty distribution, specialty pharmacy, and patient assistance program) as of September 2024. Total prescriptions since FDA approval is estimated based on the shipped quantity of ORGOVYX, with each bottle equivalent to one prescription.3
¶This coverage information is provided for informational purposes only; individual plans vary, and this may not include all plans. Sumitomo Pharma America and Pfizer make no representation or guarantee concerning coverage or reimbursement for ORGOVYX; please check with individual payers for plan-specific coverage and reimbursement information and requirements. Nothing herein may be construed as an endorsement, approval, recommendation, representation, or warranty of any kind by any plan or insurer referenced. This information is subject to change without notice. Data on file. Formulary data are provided by MMIT, LLC, as of December 2024. Transaction data are provided by SHS database as of December 2024.3
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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.
References:
- ORGOVYX (relugolix) [prescribing information]. Marlborough, MA: Sumitomo Pharma America, Inc.; 2024.
- 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. doi:10.1056/NEJMoa2004325
- Data on file. Sumitomo Pharma America, Inc.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.1.2025. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed March 4, 2025. 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.
- Protocol for: Shore ND, Saad F, Cookson MS, et al. Oral relugolix for androgen-deprivation therapy in advanced prostate cancer. N Engl J Med. 2020;382:2187-2196. doi:10.1056/NEJMoa2004325