CRENESSITY

Crinecerfont maximum plasma concentration (C max ) and area under the time concentration curve (AUC 0-24 hours ) increases dose-proportionally over the approved recommended dosage range. Upon twice daily dosing, steady state conditions are achieved in approximately 7 days with an accumulation ratio of 1.4.

AbsorptionCrinecerfont median time to reach C max (T max ) is 4 hours following oral administration of CRENESSITY. No clinically significant differences in crinecerfont C max or AUC were obse...

14.1 Adults with Classic Congenital Adrenal Hyperplasia The efficacy of CRENESSITY to reduce androgen levels and enable a reduced glucocorticoid dose while maintaining androgen control in adults with classic CAH was evaluated in a randomized, double-blind, placebo-controlled study (Study 1; NCT#04490915). This study enrolled 182 adults with classic CAH due to 21- hydroxylase deficiency on supraphysiological glucocorticoid doses and with androgen concentrations in the normal range or with inadequate androgen control. Subjects were randomized to receive CRENESSITY 100 mg twice daily (N=122) or p...

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Risk of Acute Adrenal Insufficiency or Adrenal Crisis with Inadequate Concomitant Glucocorticoid Therapy [see Warnings and Precautions ( 5.2 )] Adults: Most common adverse reactions (at least 4% for CRENESSITY and greater than placebo) are fatigue, headache, dizziness, arthralgia, back pain, decreased appetite, and myalgia. ( 6.1 ) Pedi...

CRENESSITY is contraindicated in patients with hypersensitivity to crinecerfont or any excipients of CRENESSITY. Reactions have included throat tightness, angioedema, and generalized rash [see Warnings and Precautions ( 5.1 )] . Hypersensitivity to crinecerfont or any excipients of CRENESSITY. ( 4 )

Hypersensitivity Reactions: Include throat tightness, angioedema, and generalized rash. If clinically significant hypersensitivity occurs, initiate appropriate therapy and discontinue CRENESSITY. ( 5.1 ) Risk of Acute Adrenal Insufficiency or Adrenal Crisis with Inadequate Concomitant Glucocorticoid Therapy: Continue glucocorticoids upon initiation of and during treatment with CRENESSITY. Do not reduce the glucocorticoid dose below the dose required for cortisol replacement. Any adjustment of da...

7 DRUG INTERACTIONS Strong CYP3A4 I nducers: Increase CRENESSITY morning and evening dosage 2-fold. (Section 2.3 , 7.1 ) Moderate CYP3A4 Inducers: Increase CRENESSITY evening dosage 2-fold. ( 2.4 , 7.1 ) 7.1 Effects of Other Drugs on CRENESSITY Strong CYP3A4 Inducers Increase CRENESSITY morning and evening dosages 2-fold when CRENESSITY is used concomitantly with a strong CYP3A4 inducer [see Dosag...