ORGOVYX contains the active ingredient relugolix, a GnRH receptor antagonist. It is available as a film-coated tablet for oral administration, with each tablet containing 120 mg of relugolix. Key inactive ingredients include mannitol, sodium starch glycolate, hydroxypropyl cellulose, and magnesium stearate.

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. 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 care team tells you to stop. Do not take this medication with grapefruit juice. Talk to your care team about the use of this medication 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 unless it is more than 12 hours late. If it is more than 12 hours late, skip the missed dose. Take the next dose at the normal time.

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 medication in the original container. Protect from moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, empty it out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Change in sex drive or performance -Constipation -Diarrhea -Hot flashes -Joint pain -Muscle pain

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.

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 -Irregular heartbeat or rhythm -Low levels of potassium or magnesium in the blood -An unusual or allergic reaction to relugolix, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Cisapride -Dronedarone -Ketoconazole -Levoketoconazole -Pimozide -Thioridazine This medication may also interact with the following: -Grapefruit juice -Other medications that prolong the QT interval This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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 care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. Use a condom during sex while taking this medication and for 2 weeks after stopping therapy. Tell your care team right away if you think your partner might be pregnant. This medication can cause serious birth defects. This medication may cause infertility. Talk to your care team if you are concerned about your fertility. You may need blood work done while you are taking this medication.