CRENESSITY dosing varies by age and weight1
| Age and body weight | Recommended dosage |
|---|---|
| Adults (18 and older) and children weighing ≥55 kg | 100 mg twice daily (200 mg per day) |
| Children weighing 20 to <55 kg | 50 mg twice daily (100 mg per day) |
| Children weighing 10 to <20 kg | 25 mg twice daily (50 mg per day) |
CRENESSITY is a CYP3A4 substrate¹
- CRENESSITY dose should be when coadministered with a strong or moderate CYP3A4 inducer1
- Please refer to the full Prescribing Information for full dosing information and additional considerations for patients taking CYP3A4 inducers or inhibitors
Patients prescribed CRENESSITY should continue taking GCs.1
Around-the-clock ACTH and androgen suppression
When comparing doses in a phase 2 study, twice-daily dosing led to the greatest reduction of androstenedione.2*
*Study compared 50 mg once daily, 100 mg once daily, and 100 mg twice daily. Main outcomes included change from baseline to day 14 in ACTH, 17-OHP, androstenedione, and testosterone. 100 mg twice daily led to the greatest reductions.2
A pharmacokinetic profile that
supports twice-daily dosing1
Following oral administration, the time to reach maximum CRENESSITY plasma absorption is
4 hours1
The effective half-life of
CRENESSITY is approximately
14 hours1
CRENESSITY administration
- CRENESSITY should be taken twice a day1
CRENESSITY is taken with morning and evening meals and can be timed with GC doses.
- CRENESSITY is available as capsules1
Capsules should be swallowed whole with liquid and not opened, chewed, or broken.
- CRENESSITY is available as an oral solution1
Oral solution should not be diluted and should be taken with an oral syringe.
of pediatric patients rated the oral solution as easy or very easy to take (n=35).3
Patients aged 6-17 years rated ease of administration on a 5-option scale ranging from very difficult to very easy.3
GC dose reductions during CRENESSITY clinical trials1,4,5
- Patients maintained their GC regimens for the first 4 weeks
- In CAHtalyst™ Pediatric, a personalized GC dose reduction was implemented from weeks 4 to 28 while androstenedione levels were maintained or improved*
- In CAHtalyst™ Adult, there was a protocolized GC dose reduction to the physiologic range from weeks 4 to 12, followed by an optimization over the next 12 weeks to ensure that androstenedione levels were maintained or improved*
- When possible, regimens were adjusted to remove the most nonphysiologic GC types (eg, dexamethasone, prednisone) or doses (ie, nighttime doses)
Patients prescribed CRENESSITY should continue taking GCs.1
- *In CAHtalyst™ Pediatric, maintaining or improving androstenedione levels was defined as ≤120% of the baseline value or ≤ULN for sex and either age (for Tanner stage 1) or pubertal stage (for Tanner stages 2-5) for the visit. In CAHtalyst™ Adult, it was defined as ≤120% of the baseline value or ≤ULN for age and sex.1,4,5
REFERENCES
- Crenessity. Package insert. Neurocrine Biosciences, Inc.
- Auchus RJ, Sarafoglou K, Fechner PY, et al. Crinecerfont lowers elevated hormone markers in adults with 21-hydroxylase deficiency congenital adrenal hyperplasia. J Clin Endocrinol Metab. 2022;107(3):801-812. doi:10.1210/clinem/dgab749
- Data on file. Neurocrine Biosciences, Inc.
- Sarafoglou K, Kim MS, Lodish M, et al. Phase 3 trial of crinecerfont in pediatric congenital adrenal hyperplasia. N Engl J Med. 2024;391(6):493-503. doi:10.1056/NEFMoa2404655
- Auchus RJ, Hamidi O, Pivonello R, et al. Phase 3 trial of crinecerfont in adult congenital adrenal hyperplasia. N Engl J Med. 2024;391(6):504-514. doi:10.1056/NEJMoa2404656.