One of the treatment options for advanced prostate cancer is androgen deprivation therapy, which uses drugs to lower levels of the hormones that help prostate cancer cells grow.
Current FDA-approved treatments of this type are injected or placed as small implants under can testosterone affect prostate skin.
Orgovyx is an orally administered treatment that works by blocking the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone, thereby reducing the amount of testosterone the testicles are able to make. The safety and efficacy of Orgovyx was evaluated in a randomized, open-label trial in men with advanced prostate cancer.
The patients randomly received either Orgovyx once daily or injections of leuprolide, another hormone-targeting drug, every three months for 48 weeks.
The objective was to determine if Orgovyx achieved and maintained low enough levels of testosterone castrate levelsby day 29 through end of the treatment course.
In the patients who received Orgovyx, the castration rate was The most common side effects of Orgovyx include: hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea and increased levels of certain liver enzymes.
Based on findings in animals and the mechanism of action, Orgovyx can cause fetal harm and loss of pregnancy when administered to a pregnant female; it is advised that males with female partners of reproductive potential use effective contraception during treatment and for two weeks after the last dose of Orgovyx.
The FDA, an agency within the U. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.