Pronunciation: REL ue GOE lix

Brand: Orgovyx

What is the most important information I should know about relugolix?

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is relugolix?

Relugolix is used in adult males to treat advanced prostate cancer.

Relugolix may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking relugolix?

You should not use relugolix if you are allergic to it, or if you have:

  • heart problems; or
  • long QT syndrome (in you or a family member).

Relugolix can harm an unborn baby if the father is using this medicine.

  • If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 2 weeks after your last dose.
  • Tell your doctor if your partner is pregnant or plans to get pregnant.

It may be harder for you to get a woman pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

How should I take relugolix?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Relugolix is usually taken as 3 tablets the first day, followed by 1 tablet per day.

Take the medicine at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

You will need frequent medical tests. Your heart function may need to be checked using an electrocardiogram or ECG (sometimes called an EKG).

Your doctor will determine how long to treat you with relugolix. Do not change your dose or stop using this medicine without your doctor's advice.

Store tightly closed at room temperature, away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash. Do not flush down the toilet.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking relugolix?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of relugolix?

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat, trouble swallowing.

Call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • chest pain or pressure;
  • sudden numbness or weakness on one side of the body;
  • little or no urination, pain or burning when you urinate; or
  • unusual bleeding.

Common side effects may include:

  • flushing (sudden warmth, redness, or tingly feeling);
  • feeling tired;
  • high blood sugar;
  • high cholesterol or triglycerides;
  • (anemia) low red blood cells;
  • depressed mood;
  • weight gain;
  • impotence, sexual problems;
  • abnormal growth of breast tissue;
  • diarrhea, constipation;
  • muscle or joint pain; or
  • abnormal lab tests (liver, blood).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect relugolix?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Relugolix can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Certain other drugs should not be used within 6 hours after you take relugolix. Your relugolix dose should be taken first, before other medicines. Carefully follow your doctor's instructions about how to schedule the doses of all your medicines.

Many drugs can affect relugolix. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about relugolix.

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