Orgovyx (relugolix)
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Disease Indications
Prostate Cancer
Manufacturer
Allergan USA
Usage
Oral
Medicine approved by
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Food and Drug Administration (FDA)
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We are registered with the Dutch Ministry of Health in The Hague, as an intermediary, registration number: 6730 BEM and as a wholesale distributor, registration number: 16258 G.
Package
Tablets
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Dr. Akshi Sudan
Patient Support Manager
Maria Chironi
Patient Support
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Read moreWhat 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
Four steps to access the medicines you need
How and where to buy Orgovyx: You can order Orgovyx from TheSocialMedwork if the drug has not been approved or is not available in your country.
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Step 1
You send a request for your medicine online
Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. They will be there to support and guide you in anyway possible to help you get the medicine you need.
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Step 2
We verify your prescription and medical details
Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need.
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Step 3
We source your medicine
Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.
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Step 4
We deliver your medicine
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. We will work hard to keep you informed at every step along the way and get your medicine to you quickly and safely. To date we have successfully delivered packages to over 75 countries around the world.
The Food and Drugs Administration (FDA) approval of Orgovyx (relugolix) for the treatment of adults with advanced prostate cancer was based on the data of study HERO (NCT03085095).1
HERO was a phase 3, multinational, randomized, open-label, parallel group trial to study the efficacy and safety of relugolix. The trial involved 622 men with advanced prostate cancer. For a period of 48 weeks, patients were treated with either relugolix 120 mg orally once daily or for comparison 22.5 mg leuprolide acetate depot suspension every 3 months by subcutaneous injection, the current standard of care.2
Results
The main efficacy outcome was medical castration rate, which defined as achieving and maintaining serum testosterone suppression to castrate levels (<50ng/dL) by day 29 through 48 weeks.2
Orgovyx (relugolix) reached the study endpoint, and results showed that the studied effects of relugolix were statistically better than those of leuprolide.3
Testosterone levels were reduced to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% [95% confidence interval (CI): 94.9, 97.9) of men, compared with 88.8% [95% CI: 84.6, 91.8] of men receiving leuprolide acetate injections.3
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Orgovyx (relugolix) for the approved indication.1
References
1. Full prescribing information [FDA]: Orgovyx (relugolix) [PDF]Myovant Sciences, Dec 18, 2020 2. A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer (HERO)
Clinical Trial NCT03085095, cited on Dec 23, 2020 3. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer
Shore ND, NEJM, Jun 4, 2020
Room temperature shipping
For this medication, standard shipping applies. This means that a consistent room temperature of 15 to 25°C is maintained during transit.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.
Our standard delivery time varies from 5 to 10 working days.
The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.
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Disclaimer
Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.
