Crinecerfont

Crinecerfont is used along with steroid medicine to manage androgen (testosterone-like hormone) levels in adults and children who are at least 4 years old with classic congenital adrenal hyperplasia (CAH).

Crinecerfont may also be used for other reasons that are not mentioned in this medication guide.

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.

Crinecerfont is taken twice per day in the morning and evening with a meal.

Do not stop using crinecerfont suddenly. Ask your doctor before stopping the medicine.

Swallow the capsule whole with liquids and do not crush, chew, break, or open it.

Tell your doctor if you are unable to swallow the capsules. Read and carefully follow any Instructions for Use provided with crinecerfont on how to take the oral solution. Ask your doctor or pharmacist if you don't understand all instructions.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Do not change your oral steroid medicine dose or stop it suddenly. Talk to your doctor if you have any questions.

Your doctor will need to check your progress on a regular basis and you may need medical tests.

Call your doctor if you have a planned surgery, severe injury, infection, or illness during treatment with crinecerfont.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

Store the capsules at room temperature, away from moisture and heat.

Store the oral solution in the original container in an upright position. Store the unopened liquid medicine in the refrigerator, do not freeze.

You may store the opened oral solution in the refrigerator or at room temperature. Throw away any unused liquid medicine 30 days after opening the bottle.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use crinecerfont if you are allergic to it.

Tell your doctor if you have or have ever had:

• a recent injury or surgery;
• an adrenal gland disorder; or
• fever, any illness, or infection you had within the past several weeks.

It is not known if crinecerfont will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using crinecerfont.

If you are pregnant, you may be enrolled in a pregnancy safety study to track the effects of crinecerfont on the baby.

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

Crinecerfont may cause serious side effects. Call your doctor right away if you have:

• decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods; or
• increased adrenal gland hormones--hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, sexual changes.

Common side effects of crinecerfont may include:

• tiredness, headache, dizziness;
• stuffy nose, nosebleeds;
• stomach pain, loss of appetite; or
• back pain, muscle or joint pain.

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.

Usual Adult Dose for Congenital Adrenal Hyperplasia:

Initial dose: 100 mg orally twice a day, with the morning and evening mealsUse: Adjunctive treatment to glucocorticoid replacement to control androgens in patients with congenital adrenal hyperplasia (CAH)

Usual Pediatric Dose for Congenital Adrenal Hyperplasia:

4 years and older:-Weight 10 kg to less than 20 kg: 25 mg orally twice daily -Weight 20 kg to less than 55 kg: 50 mg orally twice daily-Weight at least 55 kg: 100 mg orally twice dailyComment:-Take with the morning and evening meals.Use: Adjunctive treatment to glucocorticoid replacement for the control of androgens in patients with congenital adrenal hyperplasia (CAH)

Take the medicine as soon as you can, even if it is almost time for your next dose. Take your next dose at the regular time. Do not take two doses at one time.

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

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Other drugs may affect crinecerfont, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.