Class Name(s):

• 68:28 Pituitary

Pronunciation:

• (Please add pronunciation)

Brand Name(s):

• Crenessity^®

WHY is this medicine prescribed?

Crinecerfont is used along with glucocorticoids (steroid) to control androgen (a male sex hormone) levels in adults and children with classic congenital adrenal hyperplasia (CAH). Crinecerfont is in a class of medications called selective corticotropin-releasing factor (CRF) type 1 receptor antagonists. It works by reducing the production of androgens.

HOW should this medicine be used?

Crinecerfont comes as a capsule and solution (liquid) to take by mouth. It is taken twice daily with a meal in the morning and evening. Take crinecerfont at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take crinecerfont exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take crinecerfont even if you feel well. Do not stop taking crinecerfont or glucocorticoid medications without talking to your doctor. Do not change the dose of glucocorticoid unless your doctor tells you to do so.

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

To use the oral solution follow these steps:

• 1. Only use the bottle adapter and oral syringe provided to you. If you did not receive these items, ask your pharmacist for them.
• 2. When you first use a new bottle, open and remove the seal from the bottle. Press in the bottle adapter and leave in place.
• 3. To prepare a dose, push in the plunger of the oral syringe and insert into the bottle adapter. Then turn the bottle upside down and pull back on the plunger until you have measured the dose prescribed by your doctor.
• 4. Turn the bottle upright and remove the syringe from the bottle.
• 5. Give the dose by placing into your or your child's cheek by placing the tip of the syringe inside the cheek and slowly pushing the plunger until the full dose is given.
• 6. Place the cap over the adapter and properly store for the next dose. Rinse both parts of the syringe with water, airdry, and store in a clean, dry place.

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

Are there OTHER USES for this medication?

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

What SPECIAL PRECAUTIONS should I follow?

Before taking crinecerfont,

• tell your doctor and pharmacist if you are allergic to crinecerfont, any other medications, or any of the ingredients in crinecerfont capsules or solution. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking crinecerfont. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking crinecerfont, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking crinecerfont.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• headache
• tiredness
• dizziness (in adults)
• joint, back, or muscle pain (in adults)
• decreased appetite (in adults)
• abdominal pain (in children)
• stuffy nose or nose bleed (in children)

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

• rash; difficulty swallowing or breathing; swelling of the lips, tongue, eyes, or throat
• confusion, dizziness, severe weakness, headache, fever, nausea, vomiting, fast heartbeat, rapid breathing, unusual sweating on face or palms.

Crinecerfont 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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

Store the solution in the original bottle in an upright position. Store the unopened bottle in the refrigerator; do not freeze. After opening the bottle, store at room temperature or in a refrigerator; use within 30 days. Dispose of any unused medication after 30 days of first opening the bottle.

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. http://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 http://goo.gl/c4Rm4p for more information.

What OTHER INFORMATION should I know?

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

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 15, 2025.