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

Relugolix comes as a tablet to take by mouth. It is usually taken with or without food once daily. Take relugolix at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take relugolix exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking relugolix,

• tell your doctor and pharmacist if you are allergic to relugolix, any other medications, or any of the ingredients in relugolix tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications, temporarily stop your treatment, or monitor you carefully for side effects.
• 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.
• you should know that relugolix (Orgovyx) is intended only for use in men. Relugolix 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.
• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking relugolix.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss a dose by less than 12 hours, take the missed dose as soon as you remember it and then take the next dose at the scheduled time. However, if you miss a dose by more than 12 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you miss more than 7 days of treatment, talk to your doctor before starting to take it again. You will probably have to restart taking it at a higher dose initially.

Relugolix may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• hot flashes
• skin flushing
• sweating
• weight gain
• decreased sexual desire or ability
• muscle, back, joint, or bone pain
• fatigue
• diarrhea
• constipation
• difficulty falling asleep or staying asleep
• depression
• enlargement of the breasts

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• dizziness; fainting; heart racing; or chest pain
• swelling of the face, lips, mouth or tongue; trouble breathing or swallowing; rash; hives; red or swollen skin
• chest pain or pressure; or pain in arms, back, neck, or jaw
• sudden numbness or weakness of face, arm, or leg (especially on one side of the body); sudden confusion; trouble speaking or understanding; sudden trouble seeing in one or both eyes; or sudden trouble walking, dizziness, loss of balance or coordination

Relugolix may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (small packet included with medication to absorb moisture).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body’s response to relugolix.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking relugolix.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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