Brand Names: Orgovyx

Generic Name: relugolix

What is relugolix (Orgovyx)?
What are the possible side effects of relugolix (Orgovyx)?
What is the most important information I should know about relugolix (Orgovyx)?
What should I discuss with my healthcare provider before taking relugolix (Orgovyx)?
How should I take relugolix (Orgovyx)?
What happens if I miss a dose (Orgovyx)?
What happens if I overdose (Orgovyx)?
What should I avoid while taking relugolix (Orgovyx)?
What other drugs will affect relugolix (Orgovyx)?
Where can I get more information (Orgovyx)?

What is relugolix (Orgovyx)?

Relugolix is used to treat advanced prostate cancer.

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

What are the possible side effects of relugolix (Orgovyx)?

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

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;
breast pain or swelling;
depressed mood; or
unusual bleeding.

Common side effects may include:

flushing (sudden warmth, redness, or tingly feeling);
feeling tired;
weight gain;
impotence, sexual problems;
diarrhea, constipation;
muscle or joint pain; or
abnormal lab tests.

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 is the most important information I should know about relugolix (Orgovyx)?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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

Relugolix is not for use in women or children.

Tell your doctor if you have ever had:

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

Use effective birth control if your sex partner is pregnant or able to get pregnant. Relugolix can harm an unborn baby if the father is using this medicine. Keep using birth control for at least 2 weeks after your last dose of this medicine.

This medicine may affect fertility (your ability to have children). However, it is important to use birth control if your partner is pregnant or able to get pregnant because relugolix can harm an unborn baby.

How should I take relugolix (Orgovyx)?

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 from then on.

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 may need frequent blood tests. Your heart function may need to be checked using an electrocardiograph 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 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.

Keep the bottle tightly closed when not in use.

IMAGES

See Images

What happens if I miss a dose (Orgovyx)?

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.

If you miss more than 7 daily doses, your doctor may want you to restart the medicine by taking 3 tablets the first day and 1 daily tablet thereafter.

What happens if I overdose (Orgovyx)?

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

What should I avoid while taking relugolix (Orgovyx)?

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

What other drugs will affect relugolix (Orgovyx)?

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

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

Other drugs may affect relugolix, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information (Orgovyx)?

Your pharmacist can provide more information about relugolix.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.