Cresflut Instructions and Marketing Details

Crinecerfont, trade nameCrenessity, is a corticotropin-releasing factor1 receptor antagonist. can also be used as an auxiliary therapy for glucocorticoid replacement therapy. It has a special effect in the treatment of typical congenital adrenal hyperplasia (CAH). At the same time, Crisflutide can also effectively control androgen levels in 4 adults and children aged 4 and above with typical CAH, bringing new treatment options to patients.

1. Indications

Crisflutide is indicated primarily for the control of androgen levels in adults and children aged 4 years and older with classic congenital adrenal hyperplasia. Its safety and effectiveness have not been confirmed for children younger than 4 years old and its use is not recommended.

2. Usage and dosage

1.Adult patients: The recommended dose is 100 mg orally twice daily, taken in the morning and evening with meals.

2.Pediatric Patients: The recommended dosage for pediatric patients 4 years and older is based on body weight.

Children above 10kg20kg orally given twice a day 25mg;

Children above 20kg55kg should take orally 50mg twice a day;

Children greater than or equal to55kg should take 100mg orally twice a day.

It should be noted that patients should continue to receive glucocorticoid replacement therapy while receiving crisflutide. Four weeks after treatment, assessment of androstenedione levels can begin and glucocorticoid doses can be appropriately reduced under the supervision of a healthcare provider as clinically indicated. However, care must be taken not to reduce the glucocorticoid dose below that required for replacement therapy.

3. Adverse reactions

1.Adult patientsThe most common adverse reactions include fatigue, headache, dizziness, joint pain, back pain, decreased appetite and myalgia. These reactions are mostly mild to moderate, usually occur early in treatment, and may gradually lessen as treatment progresses.

2.Pediatric patientsThe most common adverse reactions are headache, abdominal pain, fatigue, nasal congestion and epistaxis. For pediatric patients, parents should pay close attention to their reactions and seek medical attention promptly if there are any abnormalities.

4. Warnings and Precautions

Anaphylaxis: Some patients may experience an allergic reaction to crisflutide, including throat tightness, angioedema, and generalized rash. If these clinically significant allergic reactions occur, appropriate treatment should be initiated immediately and crisflutide should be discontinued.

Risk of Adrenal Insufficiency: Patients should continue glucocorticoids at the beginning and during treatment with crisflutide to avoid acute adrenal insufficiency or adrenal crisis due to inadequate glucocorticoid therapy. Any adjustment in glucocorticoid dosage should be made under the supervision of a medical professional.

Use in stressful situations: In situations where cortisol demand is increased, such as acute intercurrent illness, severe trauma, surgery, etc., patients should use stress doses of glucocorticoids.

On 2024Decembermonth13, the U.S. Food and Drug AdministrationFDA officially approved the listing of Cresfluate under the trade nameCrenessity. However, since Cresflut has not been on the market for a long time, the specific price has not yet been determined. Patients who are concerned about Cresflut can pay attention to the FDA official website or relevant pharmaceutical news to obtain the latest updates.

Reference link: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218808s000,218820s000lbl.pdf