What is Orgovyx (relugolix) for?
Orgovyx (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.1
It is a new oral androgen deprivation therapy (ADT) prescription medication used in adults for and the only ADT medicine that is not an injection.1
It is available in tablet form containing 120 mg relugolix.1
How does Orgovyx (relugolix) work?
Prostate cancer develops when cells in the prostate start to divide and grow out of control. Hormone therapy, also known as ADT, is one of the main treatments for prostate cancer. It slows growth of prostate cancer cells by lowering testosterone levels in the body. However, the current treatment options come with various symptoms and risks, one of them being that its effects are limited.2,3
Relugolix works by reducing the amount of testosterone. It is a gonadotropin-releasing hormone (GnRH) receptor antagonist that stops the pituitary glands from making hormones called luteinizing hormone and follicle-stimulating hormone. These hormones are responsible for the production of testosterone in the testicles.2,3
By blocking the production of these hormones, relugolix lowers the amount of testosterone and can stop the growth of the cancer cells.2,3
Where has Orgovyx (relugolix) been approved?
Orgovyx (relugolix) was approved for the treatment of adults with advanced prostate cancer by:
- The Food and Drug Administration (FDA), USA, on December 18, 2020.4
Orgovyx (relugolix) was granted Priority Review by the FDA.4
It is the first and only oral treatment option for men with advanced prostate cancer.4
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Orgovyx (relugolix) taken?
The standard dosage is:1
- An initial (loading) dose of 360 mg taken on the first day to start treatment
- Thereafter 120 mg taken once daily at approximately the same time every day.
Orgovyx (relugolix) can be taken with or without food. Tablets should be swallowed whole and should not be crushed or chewed.1
Take a missed dose of as soon as you remember. If the dose was missed by more than 12 hours, the missed dose should not be taken, continue with the next scheduled dose instead.1
If treatment with Orgovyx (relugolix) is interrupted for more than 7 days, restart treatment with a loading dose of 360 mg on the first day, and continue with a dose of 120 mg once daily.1
The dose of Orgovyx (relugolix) should be modified when it is used together with oral P-gp inhibitors or with combined P-gp and strong CYP3A inducers.1
Complete information about Orgovyx (relugolix) dosage (modification) and administration can be found in the official prescribing information listed in our references section.1
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Orgovyx (relugolix)?
Common adverse reactions
The most common side effects (≥10% of patients) listed in the prescribing information include:1
- Hot flushes
- Increased blood sugar levels
- Increased blood fat (triglyceride) levels
- Muscle and joint pain
- Decreased blood hemoglobin levels
- Increased liver enzymes
- Tiredness
- Constipation
- Diarrhea
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:1
- Myocardial infarction
- Acute kidney injury
- Changes in the electrical activity of your heart (QT prolongation)
- Hemorrhage
- Urinary tract infection
Use in a specific population
Orgovyx (relugolix) can cause fetal harm when administered to a pregnant woman, it is advised to avoid pregnancies and breastfeeding. The medicine may cause fertility problems in males, which may affect your ability to father children. Talk to your healthcare provider if this is a concern for you.1
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.1
References
1. Full prescribing information [FDA]: Orgovyx (relugolix) [PDF]
Myovant Sciences, Dec 18, 2020
2. Hormone Therapy
Prostate cancer news today, cited on Dec 23, 2020
3. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer
Shore ND, NEJM, Jun 4, 2020
4. Myovant Sciences Announces FDA Approval of ORGOVYX™ (relugolix), the First and Only Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer
Myovant Sciences press release, Dec 18, 2020