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Hypothetical Patient Case Studies
WHO MAY BE RIGHT FOR ORGOVYX?
In the HERO clinical trial, ORGOVYX was studied in a wide range of patients with advanced prostate cancer, each with their own clinical presentation, lifestyle, and history.1 These are examples of fictional patients that are representative of patients enrolled in the HERO study. Please see study design for more information.
BELOW ARE CASE STUDIES THAT MAY REFLECT YOUR PATIENTS WITH ADVANCED PROSTATE CANCER:
Biochemically recurrent
Locally advanced
De novo metastatic
Recurrent metastatic
Biochemically recurrent▼
Biochemically recurrent prostate cancer
James, 64
Not an actual patient.
James is a 64-year-old man who was diagnosed with localized prostate cancer 14 months ago.
Initial Clinical Evaluation (14 Months Ago)
Stage: T3a, N0, M0Gleason score: 7 (3+4)
PSA: 8 ng/mL
ECOG PS: 0
mpMRI: Evidence of extraprostatic extension
Treatment History (12 Months Ago)
- Radical prostatectomy (PSA <0.1 ng/mL post surgery)
- Negative surgical margins
- Pelvic lymph node dissection showed no lymph node involvement
- No history of ADT
Current Clinical Evaluation
PSA: 0.4 ng/mLPSMA PET: Negative
Lifestyle
- Works as a consultant for an engineering company and frequently travels on short notice
- Active lifestyle: enjoys going to the movies with his wife, working in their garden, and actively participating in church activities on the weekends
- Married/sexually active
- Managing clinic appointments has been a challenge for him due to his busy work schedule and commitments
JAMES IS REPRESENTED IN THE HERO STUDY BY PATIENTS WITH SIMILAR CHARACTERISTICS AT BASELINE:
- 50.2% of patients had evidence of biochemical or clinical relapse after local primary intervention with curative intent2
- 71.4% of patients were ≤75 years of age2
- 68.3% of patients were nonmetastatic2
See HERO Study Design
Locally advanced prostate cancer
Fred, 68
Not an actual patient.
Fred is a 68-year-old man with locally advanced prostate cancer.
Initial Clinical Evaluation (4 Weeks Ago)
Stage: cT3b, N0, M0Gleason score: 8 (4+4)
PSA: 11.3 ng/mL
ECOG PS: 0
Bone scan: Negative
PSMA PET: Shows seminal vesicle invasion.
Referred for treatment consideration after preventive screening results indicated elevated PSA
Treatment History
- None
Lifestyle
- Works as a software analyst
- Single/sexually active
- Lives on a farm where he also breeds horses
- Spends his free time hiking with his dogs, caring for his horses, and visiting the city on weekends
FRED IS REPRESENTED IN THE HERO STUDY BY PATIENTS WITH SIMILAR CHARACTERISTICS AT BASELINE:
- 27.1% of patients had advanced localized disease not suitable for primary surgical intervention with curative intent2
- 71.4% of patients were ≤75 years of age2
- 68.3% of patients were nonmetastatic2
See HERO Study Design
De novo metastatic prostate cancer
David, 77
Not an actual patient.
David is a 77-year-old man recently diagnosed with de novo metastatic prostate cancer.
Initial Clinical Evaluation (2 Weeks Ago)
Stage: T3, N1, M1Gleason score: 9 (4+5)
PSA: 298 ng/mL
ECOG PS: 1
PSMA PET: Enlarged pelvic lymph nodes, multiple bone metastases (lesions in 5 sites)
Treatment History
- None
Comorbidities
- Bone pain
- Urinary difficulty
- Osteoporosis
- Obesity (body mass index: 42.0 kg/m2)
- History of coronary artery bypass graft for coronary artery disease (2 years ago)
- Hypertension
- High cholesterol
Lifestyle
- Retired security guard with a lower income
- Lives in a rural setting 3 hours from the nearest care center
- Lives with son and daughter-in-law
- As a result of his former occupation, most of the day-to-day activities around the house, including those related to healthcare, were managed by his recently deceased wife
DAVID IS REPRESENTED IN THE HERO STUDY BY PATIENTS WITH SIMILAR CHARACTERISTICS AT BASELINE:
- 22.7% of patients had newly diagnosed androgen-sensitive metastatic disease2
- 31.7% of patients had metastatic disease2
- At baseline:
- 79.8% of patients in the HERO study had cardiovascular or cerebrovascular risk factors, such as diabetes or hypertension2
- 67.1% of patients had lifestyle risk factors, such as a history of smoking or obesity2
- 13.9% of patients had a history of myocardial infarction or stroke2
See HERO Study Design
Recurrent metastatic prostate cancer
Stan, 78
Not an actual patient.
Stan is a 78-year-old man with recurrent metastatic prostate cancer that was first diagnosed 8 years ago as locally advanced disease.
Initial Clinical Evaluation (8 Years Ago)
Stage: T3a, N1, M0Gleason score: 8 (4+4)
PSA: 5 ng/mL
ECOG PS: 0
Treatment History
8 YEARS AGO- Initial treatment with radical prostatectomy and adjuvant EBRT
- PSA <0.1 ng/mL post surgery
5 YEARS AGO
- Biochemical recurrence (PSA 0.3 ng/mL)
- Treated with salvage ADT for 16 months
Current Clinical Evaluation
- PSA: 1.5 ng/mL
- PSA DT: 4 months
- PSMA PET: 2 pelvic lymph node lesions and development of vertebral bone metastasis
Comorbidities
- Bone pain
- Back/lumbar pain
- Type 2 diabetes
- Hypertension
- High cholesterol
Lifestyle
- Retired from corporate law
- Travels to the Caribbean every winter with his partner
- Remains active despite experiencing back pain, which raised concerns that his cancer may have recurred
- Experienced painful injection-site reaction from prior ADT
STAN IS REPRESENTED IN THE HERO STUDY BY PATIENTS WITH SIMILAR CHARACTERISTICS AT BASELINE:
- 31.7% of patients had metastatic disease2
- 11.9% of patients received previous ADT2
- 30.3% of patients received previous radiotherapy2
- At baseline:
- 79.8% of patients in the HERO study had cardiovascular or cerebrovascular risk factors, such as diabetes or hypertension2
- 13.9% of patients had a history of myocardial infarction or stroke2
See HERO Study Design
All content provided is for informational purposes only as an illustration of the type of patients for whom ORGOVYX may be an appropriate treatment. It is neither intended to be medical advice nor a substitute for professional medical judgment. The following should not be construed as suggesting any uses of ORGOVYX that may be inconsistent with the descriptions of the product in the ORGOVYX Prescribing Information.
ADT=androgen deprivation therapy; aPC=advanced prostate cancer; EBRT=external beam radiation therapy; ECOG PS=ECOG Performance Status; mpMRI=multiparametric magnetic resonance imaging; PSA=prostate-specific antigen; PSA DT=PSA doubling time; PSMA PET=prostate-specific membrane antigen positron emission tomography.
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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