Relugolix Oral Tablets

What is this medication?

RELUGOLIX (re loo GOE lix) is a medicine that decreases testosterone levels in men. It treats prostate cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ORGOVYX

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• heart failure
• history of irregular heartbeat or rhythm
• low levels of potassium or magnesium in the blood
• an unusual or allergic reaction to relugolix, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

Do not take this medicine with grapefruit juice.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• pimozide
• thioridazine

This medicine may also interact with the following medications:

• certain antibiotics such as erythromycin, clarithromycin, or telithromycin
• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections such as ketoconazole, itraconazole, or posaconazole
• certain medicines for seizures such as carbamazepine, phenobarbital, phenytoin
• grapefruit juice
• other medicines that prolong the QT interval (abnormal heart rhythm)
• rifampin
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

Men should not father a child while taking this medicine and for 2 weeks after stopping it. There is potential for serious harm to an unborn child. Talk to your health care provider for more information.

You may need blood work done while you are taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• fast, irregular heartbeat
• low potassium levels (trouble breathing; chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls; muscle cramps or pain)
• low magnesium levels (fast, irregular heartbeat; muscle cramp or pain; muscle weakness; tremors; seizures)

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation
• diarrhea
• hot flashes (flushing of skin, increased sweating)
• joint pain
• muscle pain
• unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature below 30 degrees C (86 degrees F). Keep this medicine in the original container. Keep the container tightly closed. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.