Use This Helpful Dosing Overview for You
and Your Patients
- For US Healthcare Professionals Only
- Important Safety
Information - Indication
- Prescribing
Information - Patient
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Dosing
One pill, once a day, fits into men’s lives1
The only oral androgen deprivation therapy that offers convenient and injection-free administration.1,2
- Mean effective half-life of ORGOVYX is 25 hours1
FIRST DAY
OF TREATMENT
OF TREATMENT
- Take 3 pills
- 360 mg loading dose
EVERY DAY
AFTER THAT
AFTER THAT
- Take 1 pill
- 120 mg daily dose
Pills not shown at actual size.
Actual size: 10.7 mm x 7.5 mm x 5.2 mm.3
Actual size: 10.7 mm x 7.5 mm x 5.2 mm.3
After the initial loading dose,
patients take one pill, once a day1
Can be taken with
or without food
Should be taken around
the same time each day
For oral administration only—
should be swallowed whole,
not crushed or chewed
- In patients treated with GnRH receptor agonists and antagonists for prostate cancer, treatment is usually continued upon development of nonmetastatic or metastatic castration-resistant prostate cancer1
- No dosage adjustment required in patients with mild to severe renal impairment or mild or moderate hepatic impairment1*
GnRH=gonadotropin-releasing hormone.
*The effect of end-stage renal disease with or without hemodialysis or severe hepatic impairment on the pharmacokinetics of ORGOVYX has not been evaluated.
Missed dose
- Advise patients to take a missed dose of ORGOVYX as soon as they remember1
- If the dose was missed by more than 12 hours, patients should not take the missed dose and resume with the next scheduled dose1
- If treatment with ORGOVYX is interrupted for greater than 7 days, resume administration of ORGOVYX with a 360 mg loading dose on the first day, followed by 120 mg once a day1
DOSE MODIFICATION for USE WITH P-gp INHIBITORS OR COMBINED P-gp and Strong CYP3A Inducers
- 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 required1
- 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 a day. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended ORGOVYX dose of 120 mg once a day1
PRESCRIBE ONCE-A-DAY ORAL ORGOVYX
FOR INJECTION-FREE ADMINISTRATION
FOR INJECTION-FREE ADMINISTRATION
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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.; 2023.
- 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.
- Data on file. Sumitomo Pharma America, Inc.
Thank You
Your information has been received.
We have received your request for more information about ORGOVYX® (relugolix). An ORGOVYX representative in your area will follow up soon to get you the information you need.