Crinecerfont

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 receptorantagonists. It works by reducing the production of androgens.

Are there OTHER USES for this medicine?

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

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.

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.

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 (https://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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.