ORAL DOSING

One pill, once a day, fits into men’s lives1,2

The only oral androgen deprivation therapy that offers convenient and injection-free administration.

  • Mean effective half-life of ORGOVYX is 25 hours
FIRST DAY OF TREATMENT
  • Take 3 pills
  • 360 mg loading dose
Image of the ORGOVYX 3-pill loading dose on first day of treatment
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EVERY DAY AFTER THAT
  • Take 1 pill
  • 120 mg daily dose
Image of the 1 ORGOVYX pill dose every day after that, representing the recommended dosing schedule
Pills not shown at actual size.
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
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Can be taken with or without food

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Should be taken around the same time each day

Illustration of a glass of water with pill

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 cancer
  • No dosage adjustment required in patients with mild to severe renal impairment or mild or moderate hepatic impairment*

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 dose1

  • Advise patients to take a missed dose of ORGOVYX as soon as they remember
  • If the dose was missed by more than 12 hours, patients should not take the missed dose and resume with the next scheduled dose
  • 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 day

DOSE MODIFICATION for USE WITH P-gp INHIBITORS OR COMBINED P-gp and Strong CYP3A Inducers1

  • 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
  • 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 day
PRESCRIBE ONCE-A-DAY ORAL ORGOVYX FOR INJECTION-FREE ADMINISTRATION

IMPORTANT SAFETY INFORMATION

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.

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 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.