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 * For US Healthcare Professionals Only
 * Important Safety
   Information
 * Indication
 * Prescribing
   Information
 * Patient
   Website

 * Request a Rep Rep
 * Register for Updates

THE ONLY ORAL ADT
THE ONLY ORAL ADT
 * ABOUT ORGOVYX
   * Mechanism of Action
   * Frequently Asked Questions
 * Efficacy
   * HERO Study Design
   * Sustained Testosterone Suppression
   * Rapid
     Testosterone Suppression
   * Profound Testosterone Suppression
   * PSA Reduction
   * Testosterone Recovery
   * Study Enrollment
     Criteria
 * Safety
   * HERO Study Adverse Events
   * Cardiovascular Adverse Event Data
   * Most Common Adverse Events
   * Important Safety Information
 * DOSING
   * Dosing
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     Program
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     Program
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     Resources
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   * Educational
     Resources for
     Patients

 
 
ORGOVYX Is the Only Oral Once-a-Day GnRH Receptor Antagonist for Advanced
Prostate Cancer1,2
THANKS TO YOU,
TESTOSTERONE CAN
BE CONTROLLED
THROUGHOUT
THE DIVE.
HERO STUDY DESIGN

THE HERO STUDY was a multinational, randomized, open-label, phase 3 trial in 930
men with advanced prostate cancer. Key inclusion criteria included men with
advanced prostate cancer defined as biochemical prostate-specific antigen (PSA)
or clinical relapse following local primary intervention with curative intent,
newly diagnosed castration-sensitive metastatic disease, or advanced localized
disease unlikely to be cured by local primary intervention, requiring at least 1
year of androgen deprivation therapy (ADT), ECOG 0/1. Patients were excluded if
they had received previous systemic cytotoxic treatment for prostate cancer, a
previous GnRH analog or other form of ADT >18 months total duration, or
experienced significant cardiac conditions within 6 months before study
entry.1-3

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

†*The castration rate of the subgroup of patients receiving 22.5 mg leuprolide
(n=264) was 88.0% (95% CI: 83.4%-91.4%).1 †*11.25 mg is a dosage regimen that is
not recommended for advanced prostate cancer (APC) in the United States.1

Please see additional information about ORGOVYX throughout this website.

PRIMARY ENDPOINT
SUSTAINED
TESTOSTERONE SUPPRESSION TO <50 ng/dL1
96.7%
(95% CI: 94.9-97.9)

of men achieved and maintained
testosterone suppression to
<50 ng/dL from Day 29 through
Week 48 with ORGOVYX (n=622)1

88.8%
(95% CI: 84.6-91.8)†*

of men treated with leuprolide
(n=308) achieved and maintained testosterone suppression to <50 ng/dL from Day
29 through Week 481

†The castration rate of the subgroup of patients receiving 22.5 mg leuprolide
(n=264) was 88.0% (95% CI: 83.4%-91.4%).1
Dive Into ORGOVYX Efficacy
HERO STUDY DESIGN

THE HERO STUDY was a multinational, randomized, open-label, phase 3 trial in 930
men with advanced prostate cancer. Key inclusion criteria included men with
advanced prostate cancer defined as biochemical prostate-specific antigen (PSA)
or clinical relapse following local primary intervention with curative intent,
newly diagnosed castration-sensitive metastatic disease, or advanced localized
disease unlikely to be cured by local primary intervention, requiring at least 1
year of androgen deprivation therapy (ADT), ECOG 0/1. Patients were excluded if
they had received previous systemic cytotoxic treatment for prostate cancer, a
previous GnRH analog or other form of ADT >18 months total duration, or
experienced significant cardiac conditions within 6 months before study
entry.1-3

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

†*The castration rate of the subgroup of patients receiving 22.5 mg leuprolide
(n=264) was 88.0% (95% CI: 83.4%-91.4%).1 †*11.25 mg is a dosage regimen that is
not recommended for advanced prostate cancer (APC) in the United States.1

Please see additional information about ORGOVYX throughout this website.

ORGOVYX Safety
in Clinical Trials
SAFETY DATA
Support Options for
Your Eligible Patients
FINANCIAL ASSISTANCE
SECONDARY ENDPOINT
RAPID
TESTOSTERONE SUPPRESSION1
 * 56% of men treated with ORGOVYX achieved testosterone suppression to <50
   ng/dL on Day 4‡
   * 0% of men treated with leuprolide had testosterone levels <50 ng/dL on Day
     41

Learn More
SECONDARY ENDPOINT
PROFOUND
TESTOSTERONE SUPPRESSION
DEFINED AS TESTOSTERONE CONCENTRATIONS <20 ng/dL1
 * 78% of men treated with ORGOVYX achieved profound testosterone suppression to
   <20 ng/dL on Day 15‡
   * 1% of men treated with leuprolide had testosterone levels <20 ng/dL on Day
     15

Learn More
EXPLORATORY ANALYSIS
RECOVERY
OF TESTOSTERONE LEVELS 90 DAYS
AFTER DISCONTINUATION1,2,4
 * In a substudy of 184 men who completed 48 weeks of treatment, 55% of 137 men
   treated with ORGOVYX and 3% of 47 men treated with leuprolide had their
   testosterone return to above the lower limit of normal range (>280 ng/dL) or
   baseline values 90 days after treatment discontinuation1,2,4,‡
   * This endpoint was analyzed for exploratory purposes without formal testing.
     The data from the leuprolide arm were not included in the US Prescribing
     Information for ORGOVYX

Learn More
‡Kaplan-Meier estimates within each group.1
IN THE HERO STUDY
SAFETY
OF ORGOVYX WAS ALSO EVALUATED1
 * The most common adverse events during treatment with ORGOVYX (≥10%) in the
   study were hot flush, musculoskeletal pain, fatigue,
   constipation, and diarrhea

LEARN MORE
88% of patients§ are covered nationwide║
99% of Medicare patients are covered for ORGOVYX║
SEE FORMULARY COVERAGE
IN YOUR AREA


§Patients includes Commercial, Medicare, and Medicaid. Formulary data are
provided by MMIT, LLC, as of August, 2022.

║Sources: Formulary data are provided by MMIT, LLC, as of August, 2022.
Transaction data are provided by SHS database as of August, 2022. May not
include all plans. Data on File. This data does not include generics. 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.


IMPORTANT SAFETY INFORMATION & INDICATION


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.

REFERENCES:

 1. ORGOVYX (relugolix) [prescribing information]. Brisbane, CA: Myovant
    Sciences, Inc.; 2020.
 2. 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.
 3. Shore ND, Saad F, Cookson MS, et al. HERO phase 3 trial: results comparing
    relugolix, an oral GnRH receptor antagonist, versus leuprolide acetate for
    advanced prostate cancer. Presented at: American Society of Clinical
    Oncology Virtual Scientific Program; May 29-June 2, 2020; virtual. Abstract
    5602.
 4. Data on file. Myovant Sciences, Inc.

INDICATION

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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.

Please see full Prescribing Information for ORGOVYX.

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IMPORTANT SAFETY INFORMATION & INDICATION


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.

REFERENCES:

 1. ORGOVYX (relugolix) [prescribing information]. Brisbane, CA: Myovant
    Sciences, Inc.; 2020.
 2. 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.
 3. Shore ND, Saad F, Cookson MS, et al. HERO phase 3 trial: results comparing
    relugolix, an oral GnRH receptor antagonist, versus leuprolide acetate for
    advanced prostate cancer. Presented at: American Society of Clinical
    Oncology Virtual Scientific Program; May 29-June 2, 2020; virtual. Abstract
    5602.
 4. Data on file. Myovant Sciences, Inc.

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