Relugolix (rel-ue-GOE-lix)

Treats advanced prostate cancer.

Brand Name(s):

Orgovyx

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take this medicine at the same time each day.
• Swallow the tablet whole. Do not crush, break, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, take it as soon as possible and then go back to your regular schedule. If you miss a dose and it is more than 12 hours, skip the missed dose and take your next dose at the regular time. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how relugolix works. Tell your doctor if you are using erythromycin, rifampin, or medicine that may cause heart rhythm problems.

Warnings While Using This Medicine:

• Women should not use this medicine, especially women who are pregnant or able to become pregnant. This medicine can harm an unborn baby. It can also cause birth defects if the father is using it when his sexual partner becomes pregnant. Males with female partners who can become pregnant must use an effective birth control during treatment and for at least 2 weeks after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
• Tell your doctor if you have heart problems (including heart failure) or heart rhythm problems (including long QT syndrome).
• This medicine may cause a heart rhythm problem called QT prolongation.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fast, pounding, or uneven heartbeat
• Fainting, dizziness, lightheadedness
• Muscle or bone pain
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea
• Warmth or redness in your face, neck, arms, or upper chest

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088