Corticotropin-releasing Factor Type 1 Receptor AntagonistPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Crenessity
CRINECERFONT
1 INDICATIONS AND USAGE 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) . CRENESSITY is a corticotropin-releasing factor type 1 receptor antagonist 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).
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Brand names:Crenessity
Quick Reference
Medicine ClassCorticotropin-releasing Factor Type 1 Receptor Antagonist
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- CRINECERFONT
- Brand names
- Crenessity
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life is approximately 14 hours with a mean (CV%) apparent clearance of 3
- FDA approved
- Yes
What Is Crenessity?
1 INDICATIONS AND USAGE 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) . CRENESSITY is a corticotropin-releasing factor type 1 receptor antagonist 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).
Crenessity (CRINECERFONT) belongs to the Corticotropin-releasing Factor Type 1 Receptor Antagonist class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Crenessity. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Crenessity with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Crenessity is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE 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) .
CRENESSITY is a corticotropin-releasing factor type 1 receptor antagonist 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).
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION Continue glucocorticoid replacement therapy for adrenal insufficiency associated with CAH. ( 2.1 ) Adults : 100 mg orally, twice daily with a meal in the morning and evening. ( 2.2 ) Pediatric Patients (4 years of age and older ) : Weight-based dosage orally, twice daily with a meal in the morning and evening. ( 2.2 ) See Full Prescribing Information for complete dosage and administration information. 2.1 Important Administration Information 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. 2.2 Recommended Dosage and Administration Recommended Dosage for Adults The recommende
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS 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 ) Pediatric Patients: Most common adverse reactions (at least 4% for CRENESSITY and greater than placebo) are headache, abdominal pain, fatigue, nasal congestion, and epistaxis.
- ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Neurocrine Biosciences, Inc.
- at 877-641-3461 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- Adults with Congenital Adrenal Hyperplasia ( CAH) The safety of CRENESSITY in adults was assessed in Study 1, a randomized, double-blind, placebo-controlled study of 182 adults aged 18 to 58 years with classic CAH due to 21-hydroxylase deficiency.
- A total of 122 subjects received CRENESSITY 100 mg twice daily and 59 subjects received placebo twice daily for up to 24 weeks [see Clinical Studies ( 14.1 )] .
Serious
- 5 WARNINGS AND PRECAUTIONS 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 daily glucocorticoid dosage after initiation of CRENESSITY should be performed under the supervision of a health care provider.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS 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 treatmen
How Crenessity Works
12.1 Mechanism of Action Crinecerfont is a selective corticotropin-releasing factor (CRF) type 1 receptor antagonist. Crinecerfont blocks the binding of CRF to CRF type 1 receptors in the pituitary but not CRF type 2 receptors. Crinecerfont binding to CRF type 1 receptors inhibits adrenocorticotropic hormone (ACTH) secretion from the pituitary, thereby reducing ACTH-mediated adrenal androgen production.
Pharmacokinetics
Absorption
Absorption Crinecerfont median time to reach C max (T max ) is 4 hours following oral administration of CRENESSITY
Half-Life
half-life is approximately 14 hours with a mean (CV%) apparent clearance of 3
Metabolism
Metabolism Crinecerfont is metabolized primarily by CYP3A4 and to a lesser extent by CYP2B6 in vitro
Excretion
Excretion Following a single oral 100 mg dose of radiolabeled crinecerfont, approximately 47
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Crenessitywhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
16.2 Storage and Handling 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 refriger
Frequently Asked Questions
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- Detail
Crenessity dosage guide
Adult, pediatric, renal, and hepatic dosing for Crenessity
- Detail
Crenessity side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Crenessity
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.