On January 5, 2021 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported that ORGOVYX (relugolix), the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced prostate cancer, is now available through authorized specialty distributors (Press release, Myovant Sciences, JAN 5, 2021, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-us-availability-orgovyxtm-treatment [SID1234573493]).
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"Myovant has been focused on ensuring access to ORGOVYX for men with advanced prostate cancer as quickly as possible following approval, and we are delighted to announce that it is now available," said David Marek, chief executive officer of Myovant Sciences, Inc. "As part of our commitment to redefine care for women and for men, this is a critical step as we work to bring about a new standard of care for men with advanced prostate cancer."
ORGOVYX was approved by the FDA on December 18, 2020. Myovant is committed to ensuring that men in the U.S. who are prescribed ORGOVYX can achieve fair and timely access and receive the support they may need throughout their treatment journey. As part of this commitment, Myovant has launched the ORGOVYX Support Program which provides insurance verifications, prior authorizations, copay support for commercially-insured patients, free trial for up to two months of therapy, and patient assistance for qualifying uninsured patients. For more information, please contact 833-ORGOVYX (833-674-6899), 8 a.m.–8 p.m. Eastern Time, Monday–Friday.
About ORGOVYX (relugolix)
ORGOVYX (relugolix) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for the treatment of adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.
For full prescribing information, including patient information, please click here.
Indication
ORGOVYX is approved for the treatment of adult patients with advanced prostate cancer.
Select Important Safety Information
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.
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.
Most common adverse reactions (≥ 10%) in patients receiving ORGOVYX were hot flush (54%), musculoskeletal pain (30%), fatigue (26%), constipation (12%), and diarrhea (12%).
Most common laboratory abnormalities (≥ 15%) in patients receiving ORGOVYX were glucose increased (44%), triglycerides increased (35%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), and aspartate aminotransferase increased (18%).
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.
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.