Crinecerfont Application Scope

Indications: Adjunctive treatment to glucocorticoid replacement to control androgens in adults and children aged 4 years and older with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.

crinecerfont

Crinecerfont Characteristics

Ingredients: Active ingredient: Crinecerfont; excipients include components of soft gelatin capsules or oral solution formulation.
Properties: Selective corticotropin-releasing factor type 1 (CRF1) receptor antagonist; reduces excessive adrenocorticotropic hormone (ACTH) secretion from the pituitary gland .
Specification: Available as:
- Capsules: 25 mg, 50 mg, 100 mg
- Oral solution: 50 mg/mL .
Packaging Specification:
- 25 mg capsules: 60-count bottle
- 50 mg capsules: 60-count bottle
- 100 mg capsules: 30-count bottle
- Oral solution: 30 mL bottle .
Storage:
- Capsules: Store at 15°C to 25°C (59°F to 77°F).
- Oral solution: Store refrigerated at 2°C to 8°C (36°F to 46°F). Once opened, may be stored at room temperature (15°C to 25°C) or refrigerated for up to 30 days .
Expiry Date:
- Capsules: 15 months from the date of manufacture.
- Oral solution: 18 months from the date of manufacture .
Executive Standard: Approved by the U.S. Food and Drug Administration (FDA) under NDA numbers 218808 and 218820 .
Approval Number: NDA 218808 (capsules), NDA 218820 (oral solution) .
Date of Revision: December 2024.
Manufacturer: Neurocrine Biosciences, Inc.

Guidelines for the Use of Crinecerfont

Dosage and Administration:
- Adults: 100 mg orally twice daily with morning and evening meals.
- Pediatric patients (≥4 years): Dosage is weight-based; refer to prescribing information for specific dosing guidelines .
Adverse Reactions:
- Adults: Common adverse reactions include fatigue, headache, dizziness, arthralgia, back pain, decreased appetite, and myalgia .
- Pediatric patients: Common adverse reactions include headache, abdominal pain, fatigue, nasal congestion, and epistaxis .
Contraindications: Hypersensitivity to crinecerfont or any excipients in the formulation. Reactions have included throat tightness, angioedema, and generalized rash .
Precautions:
- Monitor for signs of adrenal insufficiency, especially during periods of stress or illness.
- Adjust glucocorticoid dosing as needed during treatment.
- Use caution in patients with hepatic impairment; no dosage adjustment is necessary, but monitor for adverse effects .

Crinecerfont Interactions

Drug Interactions: Crinecerfont has moderate interactions with at least 187 other drugs. No severe or serious interactions have been reported, but patients should inform healthcare providers of all medications they are taking .

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.