Pronunciation:

kri-ne-SER-font

Brand Names:

• Crenessity

Dosage Forms:

• Solution
• Capsule, Liquid Filled

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Uses of This Medicine:

Crinecerfont is used together with steroid medicine (eg, glucocorticoids) to control androgen levels in patients with classic congenital adrenal hyperplasia (CAH).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of crinecerfont in the children younger than 4 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of crinecerfont in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Apalutamide
• Bosentan
• Carbamazepine
• Cenobamate
• Dabrafenib
• Dipyrone
• Efavirenz
• Elagolix
• Enzalutamide
• Etravirine
• Fosphenytoin
• Ivosidenib
• Lesinurad
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mitapivat
• Mitotane
• Modafinil
• Nafcillin
• Pexidartinib
• Phenobarbital
• Phenytoin
• Primidone
• Repotrectinib
• Rifabutin
• Rifampin
• Rifapentine
• Sotorasib
• St John's Wort
• Telotristat Ethyl
• Thioridazine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection or
• Injury, severe or
• Shock or
• Surgery or
• Trauma—May increase risk of sudden adrenal gland problems.

• Kidney disease, severe or end-stage—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of unwanted effects.

This medicine comes with a patient information leaflet and patient instructions. Follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine with food.

Swallow the capsule whole with liquid.

If you are unable to swallow the capsule whole, you may use the oral liquid:

• Remove the child-resistant cap by pressing it down while twisting it counterclockwise.
• While holding the bottle firmly, use the thumb on your other hand to push the press-in bottle adapter in to the bottle as far as it will go. Do not remove the adapter after it has been inserted.
• Insert the tip of the oral syringe into the press-in bottle adapter, then turn the bottle upside down.
• Slowly pull the plunger of the syringe until the plunger lines up with the prescribed dose. Turn the bottle and syringe right side up. Hold the syringe from the middle, then remove it from the bottle. Do not touch the plunger to avoid oral liquid from coming out of the syringe.
• Place the tip of the oral syringe inside your mouth and point it towards the inside of the cheek. Slowly push the plunger all the way down to give the full dose. Put the child-resistant cap back on with the press-in bottle adapter still inserted.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsule or solution):
  • Adults—100 milligrams (mg) 2 times a day, given in the morning and evening.
  • Children 4 years of age and older—Dose is based on body weight and must be determined by your doctor.
    • Weighing 55 kilograms (kg) or more—100 mg 2 times a day, given in the morning and evening.
    • Weighing 20 kg to less than 55 kg—50 mg 2 times a day, given in the morning and evening.
    • Weighing 10 kg to less than 20 kg—25 mg 2 times a day, given in the morning and evening.
  • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose, take it as soon as possible (even if it is almost time for your next dose), and then go back to your regular dosing schedule.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the capsule at room temperature.

Store the oral liquid in its original container in an upright position.

Store unopened oral liquid in the refrigerator. Do not freeze. You may also store opened oral liquid in the refrigerator or at room temperature for up to 30 days. Throw away unused oral liquid after 30 days of first opening the bottle.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including angioedema and throat tightness, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, skin rash, or trouble breathing or swallowing.

This medicine may increase the risk of adrenal gland problems. Keep using your corticosteroid medicine during treatment. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Difficulty in breathing or swallowing

fast heartbeat

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

skin itching, rash, or redness

swelling of the face, throat, or tongue

throat tightness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

bloody nose

difficulty in moving

dizziness

headache

joint pain

muscle pain or stiffness

stomach pain

stuffy or runny nose

unusual tiredness or weakness

Less common

Decreased appetite

muscle aches or cramps

swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.