Crenessity
Pronunciation: kreh-NEH-sih-tee
Generic name: crinecerfont
Dosage form: oral capsules (25 mg, 50 mg, 100 mg), oral solution (50 mg/mL)
Drug class: Adrenal corticosteroid inhibitors
What is Crenessity?
Crenessity is used to control androgen levels (a testosterone-like hormone) in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH).
- Crenessity is taken with glucocorticoids (steroids) and is available as oral capsules and an oral solution (50 mg/mL).
Crenessity’s mechanism of action involves blocking a specific type of receptor called type 1 corticotropin-releasing factor (CRF) receptor in the pituitary gland, preventing the hormone CRF from binding to it. This reduces the production of another hormone called adrenocorticotropic hormone (ACTH), reducing ACTH-mediated adrenal androgen production.
Crenessity belongs to the drug class called selective corticotropin-releasing factor (CRF) type 1 receptor antagonists.
Crenessity gained FDA approval on December 13, 2024 and is the first and only classic CAH treatment that directly reduces excess ACTH and downstream adrenal androgen production, allowing for glucocorticoid dose reduction.
Crenessity side effects
The most common side effects of Crenessity in adults are:
- tiredness
- back pain
- headache
- decreased appetite
- dizziness
- muscle pain
- joint pain.
The most common side effects of Crenessity in children are:
- headache
- nasal congestion
- stomach pain
- nose bleeds
- tiredness.
Serious side effects and warnings
Crenessity may cause the following serious side effects.
Allergic reactions. Crenessity may cause an allergic reaction. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to Crenessity, get emergency medical help right away and stop taking Crenessity.
Risk of sudden adrenal insufficiency or adrenal crisis with too little glucocorticoid (steroid) medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with Crenessity. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your health care provider if you get a severe injury, infection, or illness, or have any planned surgery during treatment with Crenessity. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine.
It is not known if Crenessity is safe and effective in children younger than 4 years of age.
These are not all the possible side effects of Crenessity. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Before taking
Do not take Crenessity if you are allergic to crinecerfont, Crenessity, or any inactive ingredients in the capsules or oral solution. See the end of this guide for a list of ingredients.
Before taking Crenessity, tell your health care provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
It is not known if Crenessity will harm your unborn baby. If you become pregnant while taking Crenessity, tell your healthcare provider right away. There is a pregnancy safety study for women who become pregnant during treatment with Crenessity.
Breastfeeding
It is not known if Crenessity passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.
How should I take Crenessity?
Take Crenessity exactly as your health care provider tells you to. Your healthcare provider will tell you how much to take and when to take it.
- Take Crenessity by mouth 2 times each day, in the morning and evening.
- Take with a meal.
Swallow Crenessity capsules whole with liquid. Tell your healthcare provider if you cannot swallow the capsule whole. Your healthcare provider may need to switch you to the Crenessity oral solution.
- If your health care provider prescribes Crenessity oral solution, you must obtain a press-in bottle adapter and oral syringes from your pharmacist so that you can measure the correct amount. Contact your pharmacist immediately if you do not have these items.
- See the Crenessity Package Insert for full instructions about how to take the Crenessity oral solution.
Do not stop taking Crenessity without talking to your healthcare provider first.
While your health care provider may lower your glucocorticoids (steroids), you should continue to take glucocorticoids (steroids) to treat adrenal insufficiency, including stress dose steroids (such as when your body may be under stress from fever, infection or surgery). Do not change your daily glucocorticoid (steroid) dose without talking to your healthcare provider.
Crenessity dosing information
Your healthcare provider will (at least initially) continue glucocorticoid replacement therapy for adrenal insufficiency associated with CAH.
Crenessity dosage for adults with CAH: Crenessity 100 mg orally, 2 times daily with a meal in the morning and evening.
Crenessity dosage for children 4 years of age and older with CAH:
- Dosage is based on weight (see the Crenessity Prescribing Information).
- The dosage is taken 2 times daily in the morning and evening.
- Take Crenessity with a meal.
What happens if I miss a dose?
If you miss a dose of Crenessity, take it as soon as you remember (even if it is almost time for your next dose). Take the next dose at your regular time.
What other medications will affect Crenessity?
Taking Crenessity with certain other medicines may cause your Crenessity to not work as well. Do not start any new medicines while taking Crenessity without talking to your healthcare provider first. Especially tell your healthcare provider if you take:
- Strong CYP3A4 inducers, such as rifampin, phenytoin, or ritonavir. Increase the Crenessity morning and evening dosage 2-fold.
- Moderate CYP3A4 inducers, such as dexamethasone, modafinil, or St. John’s Wort. Increase the Crenessity evening dosage 2-fold.
This is not a full list of side effects. Tell your healthcare provider about all your medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. See the Crenessity Prescribing Information for a full list of interactions.
Crenessity storage
Store Crenessity capsules at room temperature between 59°F to 77°F (15°C to 25°C). Do not freeze.
Store unopened Crenessity oral solution in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
- Store in the original container in an upright position.
- After opening the bottle, Crenessity oral solution may be stored in the refrigerator or at room temperature between 59°F to 77°F (15°C to 25°C) for up to 30 days.
- Use Crenessity oral solution within 30 days of first opening the bottle. Throw away (dispose of) any unused medicine after 30 days.
Keep Crenessity and all medicines out of the reach of children.
Crenessity ingredients
Active ingredient: crinecerfont
Inactive ingredients:
Crenessity capsules: lauroyl polyoxyl-32 glycerides, medium chain triglycerides, propylene glycol dicaprylate/dicaprate, and Vitamin E polyethylene glycol succinate. The capsule shell contains gelatin, glycerin, red iron oxide, Sorbitol glycerin blend, titanium dioxide, and yellow iron oxide.
Crenessity oral solution: butylated hydroxytoluene, medium-chain triglycerides, oleoyl polyoxyl glycerides, orange flavor, and saccharin.
Who makes Crenessity?
Neurocrine Biosciences, Inc., makes Crenessity.
References
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.