Relugolix

(rel" ue goe' lix)

Brand Name(s): , Orgovyx^®

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WHY is this medicine prescribed?

Relugolix is used to treat advanced prostate cancer (cancer that begins in the prostate [a male reproductive gland]) in adults. 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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

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.

What SPECIAL PRECAUTIONS should I follow?

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, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Carbatrol, Equetro, Tegretol, Teril), clarithromycin; cobicistat; cyclosporine (Neoral, Sandimmune), erythromycin (E.E.S., E-Mycin, Erythrocin), ketoconazole, rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), ritonavir (Norvir), or verapamil (Calan, Isoptin, Verelan). Many other medications may also interact with relugolix, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had long QT syndrome (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death); high or low levels of calcium, potassium, magnesium, or sodium in your blood; or heart failure.
• you should know that relugolix is only for use in men. Women should not take this medication, especially if they are or may become pregnant or are breast-feeding. 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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

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

• dizziness; fainting; heart racing; or chest pain
• 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 ([WEB]) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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. [WEB]

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 ([WEB]) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at [WEB]. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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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This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2023. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2021.