Drug updated on 4/29/2024
Dosage Form | Tablet (oral: 120 mg) |
Drug Class | Gonadotropin-releasing hormone receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with advanced prostate cancer.
Summary
- Relugolix (Orgovyx) is indicated for the treatment of adult patients with advanced prostate cancer.
- Three randomized controlled trials were reviewed to gather information about this drug and its effects on the specified indication.
- In a phase 3 trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to leuprolide, an injectable luteinizing hormone-releasing hormone agonist commonly used in treating prostate cancer; it also showed a 54% lower risk of major adverse cardiovascular events compared to leuprolide.
- A study investigating uterine fibroid-associated pain found that more patients receiving relugolix experienced significant improvement in their condition compared to those given placebo; however, there was a higher incidence rate of treatment-emergent adverse events among those treated with relugolix than placebo recipients but most were mild or moderate in intensity and did not lead to discontinuation from the study.
- Another trial evaluated relugolix combined with estradiol and progestin for endometriosis-associated pain management; results revealed significantly improved outcomes among women who received this combination therapy as opposed to placebo alone - they reported less severe dysmenorrhoea and non-menstrual pelvic pain along with reduced opioid use which suggests potential long-term benefits against repeated surgical treatments or reliance on opioids for managing endometriosis-related discomforts.
- Across all studies reviewed, common side effects associated with Orgovyx included hot flushes, metrorrhagia (abnormal bleeding), hyperhidrosis (excessive sweating), menorrhagia (heavy menstrual bleeding), nasopharyngitis (common cold symptoms) while some cases reported suicidal ideation although no deaths occurred during these trials.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Orgovyx (relugolix) Prescribing Information. | 2022 | Myovant Sciences, Inc., Brisbane, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
The cardiovascular effects of gonadotropin-releasing hormone antagonists in men with prostate cancer. | 2022 | European Heart Journal. Cardiovascular Pharmacotherapy. |
The efficacy and safety of relugolix compared with degarelix in advanced prostate cancer patients: a network meta-analysis of randomized trials. | 2022 | European Urology Oncology |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Relugolix in clinical practice: the best route for all? | 2023 | Oncologist |