Orgovyx (relugolix) is a prescription medicine used to treat advanced prostate cancer (cancer that begins in the prostate [a male reproductive gland]) in adult men. Relugolix belongs to a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists.

Orgovyx tablets work by decreasing the amount of testosterone (a male hormone) produced by the body. This may slow or stop the spread of prostate cancer cells that need testosterone to grow.

Orgovyx may decrease fertility in men. Talk to your doctor about the risks.

Orgovyx is intended only for use in men. This medicine is not intended for use alone in women, but can be used in combination with other medications for other uses. If you are a male and your female partner can become pregnant, you should use effective contraception during treatment and for 2 weeks after the last dose. Relugolix may harm the fetus.

Tell your doctor if you or anyone in your family has or has ever had long QT syndrome (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death). Also, tell your doctor if you have or have ever had an electrolyte imbalance in your blood, heart failure, diabetes, high triglycerides (fatty substances in the blood), anemia, or liver problems.

Tell your doctor and pharmacist if you are allergic to relugolix, any other medications, or any of the ingredients in the tablets. Ask your pharmacist for a list of the ingredients.

Take 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.

Take the medicine at the same time each day, with or without food.

Swallow the Orgovyx tablet whole and do not crush, chew, or break the tablet.

You will need frequent medical tests. Your heart function may need to be checked using an electrocardiogram 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 tightly closed 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.

Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash. Do not flush down the toilet.

Usual Adult Dose 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

You should not use Orgovyx if you are allergic to relugolix, or if you have:

• heart problems; or

• long QT syndrome (in you or a family member).

Orgovyx can harm an unborn baby and cause loss of pregnancy (miscarriage).

• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 2 weeks after your last dose.

• Tell your doctor if your partner is pregnant or plans to get pregnant.

It may be harder for you to get a woman pregnant while you are using Orgovyx. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Use the medicine 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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, trouble swallowing.

Orgovyx may cause serious side effects. 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; or

• unusual bleeding.

Common Orgovyx side effects may include:

• flushing (sudden warmth, redness, or tingly feeling);

• feeling tired;

• high blood sugar;

• high cholesterol or triglycerides;

• (anemia) low red blood cells;

• depressed mood;

• weight gain;

• impotence, sexual problems;

• abnormal growth of breast tissue;

• diarrhea, constipation;

• muscle or joint pain; or

• abnormal lab tests (liver, blood).

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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Orgovyx can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Certain other drugs should not be used within 6 hours after you take Orgovyx. Your dose should be taken first, before other medicines. Carefully follow your doctor's instructions about how to schedule the doses of all your medicines.

Many drugs can interact with relugolix. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.