Source: FDA, National Drug Code (US) Revision Year: 2024
CRENESSITY is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).
Patients receiving CRENESSITY should continue glucocorticoid replacement therapy for the adrenal insufficiency associated with congenital adrenal hyperplasia (see Warning and Precautions (5.2).
Androstenedione levels can be assessed beginning four weeks after CRENESSITY initiation to inform reduction in glucocorticoid dosage as clinically indicated. Do not reduce the glucocorticoid dosage below that required for replacement therapy.
The recommended CRENESSITY dosage for adults is 100 mg orally, twice daily with a meal in the morning and evening [see Clinical Pharmacology (12.3)].
The recommended CRENESSITY dosage for pediatric patients 4 years of age and older is weight-based and administered orally, twice daily with a meal in the morning and evening (see Table 1) [see Clinical Pharmacology (12.3)].
Table 1. Recommended CRENESSITY Weight-Based Dosage for Pediatric Patients 4 Years of Age and Older:
| Weight | Dosage Regimen with a Meal |
|---|---|
| 10 kg to less than 20 kg | 25 mg orally twice daily |
| 20 kg to less than 55 kg | 50 mg orally twice daily |
| Greater than or equal to 55 kg | 100 mg orally twice daily |
In adults, increase the CRENESSITY dosage to 200 mg orally, twice daily with a meal in the morning and evening when used concomitantly with strong CYP3A4 inducers [see Drug Interactions (7.1)].
In pediatric patients, increase the CRENESSITY dosage with a meal in the morning and evening when used concomitantly with strong CYP3A4 inducers as shown in Table 2 [see Drug Interactions (7.1)].
Table 2. Dosage Increase of CRENESSITY for Use with Strong CYP3A4 Inducers in Pediatric Patients 4 Years of Age and Older:
| Weight | Dosage Regimen with a Meal |
|---|---|
| 10 kg to less than 20 kg | 50 mg orally twice daily |
| 20 kg to less than 55 kg | 100 mg orally twice daily |
| Greater than or equal to <55 kg | 200 mg orally twice daily |
In adults, increase the CRENESSITY dosage to 200 mg orally with the evening meal when used concomitantly with moderate CYP3A4 inducers. The CRENESSITY dosage of 100 mg with the morning meal remains unchanged [see Drug Interactions (7.1)].
In pediatric patients, increase the CRENESSITY dosage with the evening meal when used concomitantly with moderate CYP3A4 inducers as shown in Table 3 [see Drug Interactions (7.1)].
Table 3. Dosage Increase of CRENESSITY for Use with Moderate CYP3A4 Inducers in Pediatric Patients 4 Years of Age and Older:
| Dosage Regimen with a Meal | ||
|---|---|---|
| Weight | Morning Dose | Evening Dose |
| 10 kg to less than 20 kg | 25 mg orally | 50 mg orally |
| 20 kg to less than 55 kg | 50 mg orally | 100 mg orally |
| Greater than or equal to 55 kg | 100 mg orally | 200 mg orally |
Administer CRENESSITY orally, twice daily, with a meal in the morning and evening [see Clinical Pharmacology (12.3)].
Take CRENESSITY capsules orally and swallow whole with liquid.
Refer patients and/or caregivers to the Instructions for Use (IFU) for complete administration instructions.
Discard any unused CRENESSITY oral solution after 30 days of first opening the bottle [see How Supplied/Storage and Handling (16.2)].
If a dose or doses are missed, advise the patient to take one dose of CRENESSITY as soon as possible (even if it is soon before the next scheduled dose) and then to resume the regular dosing schedule.
CRENESSITY Capsules
Store at 15°C to 25°C (59°F to 77°F).
Packaged in child-resistant HDPE bottles. Do not freeze.
CRENESSITY Oral Solution
Store and dispense in original container. Store CRENESSITY Oral Solution in an upright position.
Store unopened bottles under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze.
Once a bottle is opened for use, it may be stored under refrigeration at 2°C to 8°C (36°F to 46°F) or at room temperature (15°C to 25°C [59°F to 77°F]) for up to 30 days. Discard any unused oral solution after 30 days of first opening the bottle.
Packaged in child-resistant PET bottles.
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