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ORGOVYX® (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.1
ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or to any of the product components.1
ORGOVYX is a nonpeptide GnRH receptor antagonist that competitively binds to pituitary GnRH receptors, thereby directly reducing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and consequently testosterone. The mechanism of action of ORGOVYX does not cause an initial testosterone surge and therefore helps avoid potential tumor flare.1,2 Learn more about ORGOVYX’s Mechanism of Action.

ORGOVYX is the only oral, once-a-day gonadotropin-releasing hormone (GnRH) receptor antagonist to treat adult patients with advanced prostate cancer. It should be initiated with a loading dose of 360 mg on the first day. Treatment should continue with a 120 mg dose taken orally once a day at approximately the same time each day.1

ORGOVYX can be taken with or without food. Tablets should be swallowed whole and should not be crushed or chewed.1 Learn more.

In the HERO study, patients were excluded who had previously received a GnRH analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for greater than 18 months’ total duration. If androgen deprivation therapy was received for less than or equal to 18 months’ total duration, then that androgen deprivation therapy must have been completed at least 3 months prior to the start of the HERO trial. If the dosing interval of the androgen deprivation therapy depot was longer than 3 months, the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of that depot.2
The HERO study was a multinational, randomized, open-label, phase 3 study in 934* men with advanced prostate cancer. 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 [or 11.25 mg† in Japan and Taiwan per local guidelines] subcutaneously every 3 months [n=308]) for 48 weeks.1,2 View key inclusion and exclusion criteria for the HERO study design on this website.

*Two patients in each arm did not receive the study treatment and were not included.1

†11.25 mg is a dosage regimen that is not recommended for advanced prostate cancer in the United States.1

The primary endpoint of the HERO study was sustained testosterone suppression rate (defined as the cumulative probability of testosterone suppression to <50 ng/dL while on study treatment from Day 29 through Week 48).1,2 View the study design.
  • In the HERO study, 96.7% of men treated with ORGOVYX achieved sustained testosterone suppression to <50 ng/dL from Day 29 through Week 481
    • 88.8% of men treated with leuprolide sustained testosterone suppression from Day 29 through Week 481
  • In the HERO study, on Day 4, 56% of men treated with ORGOVYX achieved testosterone suppression to <50 ng/dL1*
    • 0% of men treated with leuprolide had testosterone levels <50 ng/dL on Day 41
  • In the HERO study, on Day 15, 99% of men treated with ORGOVYX achieved testosterone suppression to <50 ng/dL1*
    • 12% of men treated with leuprolide had testosterone levels <50 ng/dL on Day 151
  • In the HERO study, on Day 15, 78% of men treated with ORGOVYX achieved profound testosterone suppression defined as testosterone levels <20 ng/dL1*
    • 1% of men treated with leuprolide had testosterone levels <20 ng/dL on Day 151
  • In the HERO study, on Day 29, 95% of men treated with ORGOVYX achieved profound testosterone suppression defined as testosterone levels <20 ng/dL1*
    • 57% of men treated with leuprolide had testosterone levels <20 ng/dL on Day 291

Learn more about the HERO study design and the efficacy results for ORGOVYX.

*Kaplan-Meier estimates within each group.1

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.

In the HERO study, 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.1 Learn more about serious adverse reactions in the HERO study.

Permanent discontinuation of ORGOVYX due to adverse reactions occurred in 3.5% of patients. Adverse reactions which resulted in permanent discontinuation of ORGOVYX in ≥0.3% of patients included atrioventricular block (0.3%), cardiac failure (0.3%), hemorrhage (0.3%), increased transaminases (0.3%), abdominal pain (0.3%), and pneumonia (0.3%).1

Dosage interruptions of ORGOVYX due to an adverse reaction occurred in 2.7% of patients. Adverse reactions which required dosage interruption in ≥0.3% of patients included fracture (0.3%).1

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%).1 Learn more about AEs in the HERO study.

Clinically relevant adverse reactions in <10% of patients who received ORGOVYX included increased weight, insomnia, gynecomastia, hyperhidrosis, depression, and decreased libido.1

If there are further questions, please direct them to Sumitomo Pharma America and Pfizer Medical information here.

In the HERO study, 622 patients received oral ORGOVYX. Among those, 16% (99/622) of patients received concomitant radiotherapy and 3% (17/622) of patients received concomitant enzalutamide with ORGOVYX.1

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. Treatment with ORGOVYX may be interrupted for up to 2 weeks if a short course of treatment with a P-gp inhibitor is required.1

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.1

Please see the full Prescribing Information for potential drug interactions.

Please visit the FDA Drug Development and Drug Interactions webpage: Table of Substrates, Inhibitors and Inducers for a list of examples of P-gp inhibitors and CYP3A inducers.

ORGOVYX Support Program offers support to help your patients get started and stay on track while on treatment. You can enroll your patients in the program. The ORGOVYX Support Program includes:

  • Financial Assistance§—Copay assistance is available for eligible commercially insured patients for as little as $10 per month. See terms and conditions below. Learn more
  • Reimbursement Support—Can help assist your patients with access challenges, including benefit verification, providing information about prior authorizations, and appeals processes. Learn more
  • ORGOVYX Bridge ProgramII—Eligible commercially insured patients who are experiencing coverage issues can receive ORGOVYX at no cost for a limited period of time. See terms and conditions below. Learn more
  • Nurse Support—Nurses are available to help answer patients’ general questions about ORGOVYX and offer lifestyle tips
  • ORGOVYX Education—Provides educational resources to help support patients. Learn more

For more information, call toll-free 1-833-ORGOVYX (1-833-674-6899), Monday-Friday, 8 AM-8 PM ET. Or visit us online here.

§The ORGOVYX Copay Assistance Program (“Copay Program”) is for eligible patients with commercial prescription insurance for ORGOVYX. With this Copay Program, eligible patients will pay as little as $10 per month, subject to a maximum of $10,000 per calendar year. After the annual maximum of $10,000 for ORGOVYX is reached, patient will be responsible for the remaining monthly out-of-pocket costs. This Copay Program may not be redeemed more than once per 21 days. 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. Offer is not valid for cash-paying patients. Patient must be a resident of the U.S., Puerto Rico, or U.S. Territories. This Copay Program is void where prohibited by state law and on the date an AB generic equivalent for ORGOVYX becomes available. Certain rules and restrictions apply. This offer is not insurance. This offer cannot be combined with any other coupon, free trial, discount, prescription savings card, or other offer. This offer is not conditioned on any past, present, or future purchase, including refills. 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. 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. Sumitomo Pharma America reserves the right to revoke, rescind, or amend this offer without notice. The ORGOVYX Copay Program is valid through December 31, 2024.
IIThe ORGOVYX Bridge Program ("Bridge Program") provides ORGOVYX at no cost for a limited period (up to 4 months) in a calendar year to eligible, commercially-insured patients, who have been prescribed ORGOVYX for an FDA-approved indication, and whose insurance coverage is delayed or who experience a temporary lapse in coverage. Prescribers must complete the Bridge Program prescription on the start form. By participating, patient acknowledges intent to pursue insurance coverage for ORGOVYX with their healthcare provider. Patients will receive their maintenance drug supply each month for up to 4 months or until they receive insurance coverage approval, whichever occurs earlier. The Bridge Program is not available 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. Patients must be residents of the United States or US Territories. The Bridge Program is not available to patients who are uninsured or where prohibited by law such as Massachusetts and Minnesota. Patients may be asked to reverify insurance coverage status during the course of the Bridge Program. Patients and participating prescribers agree not to seek reimbursement for all, or any part of the benefit received by the patient through this Bridge Program. No purchase necessary. The Bridge Program is not health insurance, nor is participation a guarantee of insurance coverage. Other limitations may apply. Sumitomo Pharma America reserves the right to rescind, revoke, or amend the Bridge Program and discontinue support at any time without notice.
You can see formulary coverage in your area by using our Formulary Lookup Tool.
You can contact your local representative for additional information or assistance.

Educational resources for healthcare providers can be found online here.
Educational resources for your patients can be found online here.

For your convenience, you can request a local representative for additional resources or assistance.