crinecerfont

Contraindicated in:

Hypersensitivity;
Severe renal impairment or end-stage renal disease.

Use Cautiously in:

Acute illness, significant trauma, or surgical procedures (↑ risk of acute adrenal insufficiency);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <4 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

EENT: epistaxis, nasal congestion

Endo: ACUTE ADRENAL INSUFFICIENCY

GI: abdominal pain

Hemat: neutropenia

Metab: ↓appetite

MS: arthralgia, back pain, myalgia

Neuro: fatigue, headache, dizziness, SUICIDAL IDEATION

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

Strong CYP3A inducers, including rifampin, and moderate CYP3A inducers may ↓ levels and effectiveness; ↑ crinecerfont dose.

Availability ⬆ ⬇

Capsules: 25 mg; 50 mg; 100 mg
Oral solution orange flavor: 50 mg/mL

Route/Dosage ⬆ ⬇

PO (Adults ): 100 mg twice daily in the morning and evening. Concurrent use of strong CYP3A4 inducer: 200 mg twice daily in the morning and evening. Concurrent use of moderate CYP3A4 inducer: 100 mg in the morning and 200 mg in the evening.
PO (Children ≥4 yr and ≥55 kg): 100 mg twice daily in the morning and evening. Concurrent use of strong CYP3A4 inducer: 200 mg twice daily in the morning and evening. Concurrent use of moderate CYP3A4 inducer: 100 mg in the morning and 200 mg in the evening.
PO (Children ≥4 yr and 20–<55 kg): 50 mg twice daily in the morning and evening. Concurrent use of strong CYP3A4 inducer: 100 mg twice daily in the morning and evening. Concurrent use of moderate CYP3A4 inducer: 50 mg in the morning and 100 mg in the evening.
PO (Children ≥4 yr and 10–<20 kg): 25 mg twice daily in the morning and evening. Concurrent use of strong CYP3A4 inducer: 50 mg twice daily in the morning and evening. Concurrent use of moderate CYP3A4 inducer: 25 mg in the morning and 50 mg in the evening.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Blocks the binding of corticotropin-releasing factor (CRF) to CRF type 1 receptors in the pituitary gland, which inhibits adrenocorticotropic hormone secretion from the pituitary and subsequently decreases androgen production from the adrenal glands.

Therapeutic effects:

Reduction in glucocorticoid daily dose while androgen levels are controlled.

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification: temporary class

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following oral administration unknown. High-fat meals significantly ↑ absorption.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Primarily metabolized by the liver via the CYP3A4 isoenzyme and to a lesser extent by the CYP2B6, CYP2C8, and CYP2C19 isoenzymes. 47% excreted in feces (3% as unchanged drug); 2% excreted in urine.

Half-Life: 14 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	4 hr	12 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of crinecerfont. Advise patient to take as directed with food. If a dose or doses are missed, advise the patient to take one dose of as soon as possible (even if it is soon before the next scheduled dose) and then to resume the regular dosing schedule. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Advise patients and family to call 911 and immediately seek treatment for signs and symptoms of hypersensitivity reactions (difficulty breathing; chest tightness; hives; rash; light-headedness; itching; swelling of the face, lips, tongue, or throat).
May cause depression or suicide. Instruct patients and caregivers to monitor for emergence of suicidal thoughts and behaviors. Notify health care professional immediately if suicidal thoughts; new or worsening depression; anxiety; changes in behavior or mood; thoughts of suicide, dying, or hurting self; or acting on dangerous impulses occur. Instruct patient to carry wallet card and to call the National Suicide Prevention Lifeline at 1-800-273-8255 or visit www.988lifeline.org if they experience suicidal thoughts.
Advise patient to report signs and symptoms of adrenal insufficiency (fatigue, weakness, nausea and vomiting, feeling faint).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. If crinecerfont is administered during pregnancy or if a patient becomes pregnant while receiving crinecerfont, health care providers should report exposure to crinecerfont by calling 1-855-CRNSITY (1-855-276-7489).

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Indications ⬇

Contraind./Precautions ⬆ ⬇