Generic name: relugolix (REL ue GOE lix)
Brand name: Orgovyx
Drug class: Gonadotropin-releasing hormone antagonists
Orgovyx (relugolix) is a GnRH receptor antagonist that blocks the pituitary gland from making certain hormones.
Orgovyx is a prescription medicine used to treat advanced prostate cancer.
It is not known if Orgovyx is safe or effective in females or in children.
Orgovyx 120 mg tablets are film-coated, light red, almond shaped, with the imprint "R" on one side and "120" on the other side. The tablets are available in bottles or blister packs.
Warnings
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Before taking this medicine
Orgovyx is not for use in women or children.
To make sure Orgovyx is safe for you, tell your doctor if you have ever had:
- heart problems; or
- long QT syndrome (in you or a family member).
Use effective birth control if your sex partner is pregnant or able to get pregnant. Relugolix can harm an unborn baby if the father is using Orgovyx. Keep using birth control for at least 2 weeks after your last dose of this medicine.
Relugolix may affect fertility (your ability to have children). However, it is important to use birth control if your partner is pregnant or able to get pregnant because relugolix can harm an unborn baby.
How should I take Orgovyx?
Use Orgovyx exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Orgovyx is usually taken as 3 tablets the first day, followed by 1 tablet per day from then on.
Take Orgovyx at the same time each day, with or without food.
Swallow the tablet whole and do not crush, chew, or break it.
You may need frequent blood tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).
Your doctor will determine how long to treat you with Orgovyx. Do not change your dose or stop using this medicine without your doctor's advice.
Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.
Keep the bottle tightly closed when not in use.
Dosing information
Usual Adult Dose of Orgovyx for Prostate Cancer:
Loading Dose: 300 mg orally once on the first day
Maintenance Dose: 120 mg orally once a day
Comment:
-Treatment is usually continued upon development of nonmetastatic or metastatic castration-resistant prostate cancer in patients treated with GnRH receptor agonists and antagonists.
Use: For the treatment of adult patients with advanced prostate cancer
What happens if I miss a dose?
Take Orgovyx as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.
If you miss more than 7 daily doses, your doctor may want you to restart the medicine by taking 3 tablets the first day and 1 daily tablet thereafter.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Orgovyx?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Orgovyx side effects
Get emergency medical help if you have signs of an allergic reaction to Orgovyx: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
- chest pain or pressure;
- sudden numbness or weakness on one side of the body;
- little or no urination, pain or burning when you urinate;
- breast pain or swelling;
- depressed mood; or
- unusual bleeding.
Common Orgovyx side effects may include:
- flushing (sudden warmth, redness, or tingly feeling);
- feeling tired;
- weight gain;
- impotence, sexual problems;
- diarrhea, constipation;
- muscle or joint pain; or
- abnormal lab tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Orgovyx?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Certain other drugs should not be used within 6 hours after you take this medicine. Your Orgovyx dose should be taken first, before the other medicine. Carefully follow your doctor's instructions about how to schedule the doses of all your medicines.
Other drugs may interact with relugolix, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Inactive ingredients
Mannitol, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, and carnauba wax. mannitol, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, and carnauba wax.