Relacorilant

Relacorilant is used to treat certain types of ovarian (female reproductive organs where eggs are formed), fallopian tube (tube that transports eggs released by the ovaries to the uterus), or primary peritoneal (layer of tissue that lines the abdomen) cancer. Relacorilant is in a class of medications called glucocorticoid receptor antagonists. It works by blocking glucocorticoid receptors, which helps stop the spread and growth of cancer cells.

Relacorilant comes as a capsule to take by mouth. Take with food once on the day before, the day of, and the day after you receive chemotherapy. Your doctor will tell you when to take relacorilant. Take relacorilant at around the same time every day.

Take relacorilant exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them.

If you vomit after taking relacorilant, do not take another dose. Continue your regular dosing schedule.

Your doctor may need to delay or permanently stop your treatment or decrease your dose of relacorilant depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

The length of your treatment depends on how well you respond to the medication and the side effects you experience. Continue to take relacorilant even if you feel well. Do not stop taking relacorilant without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking relacorilant,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with relacorilant. Other medications may cause dosing changes or extra monitoring when taken with relacorilant. Make sure you have discussed any medications you are currently taking or plan to take before starting relacorilant with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking relacorilant, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with relacorilant: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking relacorilant. Do not start any of these medications while taking relacorilant without discussing with your healthcare provider.
• tell your doctor if you have an infection or if you have or have ever had adrenal insufficiency (condition in which the body does not produce enough of certain natural substances) or liver problems.
• tell your doctor if you or your partner are pregnant or plan to become pregnant. You or your partner should not become pregnant while you are taking relacorilant. You may have to take a pregnancy test before starting treatment. You and your partner should use effective birth control to prevent pregnancy during treatment and for 1 week after your final dose. Talk to your doctor about what birth control would work best for you and your partner. If you or your partner become pregnant while taking relacorilant, call your doctor immediately. Relacorilant may harm the fetus.tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while you are taking relacorilant and for 1 week after your final dose.
• tell your doctor if you have had surgery, including dental surgery, within the last 30 days. Also, if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking relacorilant.
• tell your doctor if you have a medical condition and take a steroid medication to treat it. Relacorilant may make steroid medications less effective. Call your doctor right away if the symptoms of your other medical condition get worse.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Take the missed dose as soon as you remember it. However, if more than 12 hours passed since the missed dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Relacorilant may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• decreased appetite
• diarrhea
• mouth sores
• tiredness
• swelling of the hands, feet, ankles, or lower legs
• rash
• redness or swelling around the fingernails or toenails
• bad taste in the mouth
• dry eyes

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fever, chills, cough, weakness, confusion, or other signs of infection
• feeling dizzy or lightheaded, fainting, unusual weakness, worsening nausea or vomiting, or weight loss
• numbness, burning, or tingling in the hands or feet
• unusual bruising or bleeding

Relacorilant may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to relacorilant.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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