ORGOVYX is the only oral once-a-day GnRH receptor
antagonist for advanced prostate cancer1
Fight for your patients at different
stages of advanced prostate cancer
for ORGOVYX
Part D could impact your patients
NCCN Clinical Practice Guidelines in Oncology
(NCCN Guidelines®) Recommend3
NCCN Guidelines® recommend relugolix (ORGOVYX) as an NCCN Category 2A* treatment option for certain patients with advanced prostate cancer†
Some recommendations may fall outside of the ORGOVYX US Prescribing Information. Sumitomo Pharma America and Pfizer do not recommend any uses of ORGOVYX that are not consistent with full US Prescribing Information.
*A Category 2A recommendation is based on lower-level evidence and indicates uniform NCCN consensus that the intervention is appropriate.3
†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.3
With an estimated 1 million + prescriptions filled since January 2021, consider ORGOVYX for appropriate patients with advanced
prostate cancer1,2‡
of Medicare patients are covered for ORGOVYX nationally2§
of commerical patients are covered for ORGOVYX nationally2§
of Medicare patients are covered for ORGOVYX nationally2§
of commerical patients are covered for ORGOVYX nationally2§
See formulary coverage
in your area
See formulary coverage
in your area
||
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‡
Based on internal demand data (specialty distribution, specialty pharmacy, and patient assistance program) as of November 2025. Total prescriptions since FDA approval is estimated based on the shipped quantity of ORGOVYX, with each bottle equivalent to one prescription.2
§
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 November 2025. Transaction data are provided by SHS database as of November 2025.2
*
GnRH=gonadotropin-releasing hormone; NCCN=National Comprehensive Cancer Network.
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 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 an oral P-gp inhibitor increases relugolix exposure, 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 and separate dosing by at least 6 hours. Monitor patients for increased adverse reactions. Treatment with ORGOVYX may be interrupted for up to 2 weeks if a short course of treatment with a P-gp inhibitor is required. Resume ORGOVYX after the P-gp inhibitor is discontinued. If treatment with ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a 360 mg loading dose on the first day and continue with 120 mg once daily.
Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases relugolix exposure, 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 full Prescribing Information for ORGOVYX.
INDICATION
ORGOVYX® (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.
References: 1. ORGOVYX (relugolix). Prescribing information. Sumitomo Pharma America, Inc.; 2025. 2. Data on file. Sumitomo Pharma America, Inc. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.5.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed January 23, 2026. 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.