Crinecerfont Capsules

What is this medication?

CRINECERFONT (KRI ne SER font) treats congenital adrenal hyperplasia (CAH), a condition that affects the adrenal glands. These glands make hormones your body needs to help respond to stress. It works by helping your body balance the levels of certain hormones. This can lower the amount of steroids you need to take, which can decrease side effects.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Crenessity

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• An unusual or allergic reaction to crinecerfont, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Swallow the capsules whole. Take it with food at the start of a meal. Keep taking it unless your care team tells you to stop.

Talk with your care team about the use of this medication in children. While it may be prescribed for children as young as 4 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can, even if it is almost time to take your next scheduled dose. Take the next dose at the normal time.

What may interact with this medication?

• St. John's wort

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medication works as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

It is important to keep taking your steroid medications while taking this medication. Your care team may lower your steroid dose. Do not change your dose without first talking to your care team. Keep taking stress dose steroids as needed when your body is under stress from fever, infection, or surgery. Talk to your care team right away if you have nausea, vomiting, loss of appetite, unusual weakness or fatigue, or dizziness. They may need to change your steroid dose.

Talk to your care team if you may be pregnant. This medication has not been well studied during pregnancy.

Talk to your care team about this medication if you are breastfeeding. There are benefits and risks to taking medications while breastfeeding. Your care team can help you find the option that works for you.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Dizziness
• Fatigue
• Headache
• Joint pain
• Loss of appetite
• Stomach pain
• Stuffy nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.