Crinecerfont

Crinecerfont is indicated as an adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients aged 4 years and older with classic congenital adrenal hyperplasia (CAH).

• Crinecerfont is available under the following different brand names: Crenessity.

Common side effects of Crinecerfont include:

• tiredness
• headache
• dizziness
• joint pain
• back pain
• decreased appetite
• muscle pain
• nasal congestion 
• nose bleeds
• stomach pain

Serious side effects of Crinecerfont include:

• allergic reaction includes tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash
• risk of sudden adrenal insufficiency or adrenal crisis with too little glucocorticoid (steroid) medicine

Rare side effects of Crinecerfont include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsule

• 25 mg
• 50 mg
• 100 mg

Oral solution

• 50 mg/mL (30-mL bottle)

CAH

Adult dosage

• 100 mg orally two times a day with morning and evening meals

Pediatric dosage

• Children aged 4 years and older with weight-based dosing
  • Take with morning and evening meals
  • Weighing between 10 to less than 20 kg: 25 mg orally two times a day 
  • Weighing between 20 to less than 55 kg: 50 mg orally two times a day 
  • Weighing 55 kg and more: 100 mg orally two times a day 

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Crinecerfont has severe interactions with no other drugs
• Crinecerfont has serious interactions with no other drugs
• Crinecerfont has moderate interactions with at least 187 other drugs
• Crinecerfont has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to crinecerfont or any excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Crinecerfont?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Crinecerfont?”

Cautions

• Hypersensitivity reactions
  • A hypersensitivity reaction, including throat tightness, angioedema, and generalized rash, occurred in an individual after 3 days of treatment
  • Discontinue and initiate appropriate therapy if a significant hypersensitivity reaction occurs
• Risk of acute adrenal insufficiency or adrenal crisis
  • Continue glucocorticoids upon initiation of and during crinecerfont treatment
    • Do not reduce glucocorticoid dose below the dose required for cortisol replacement
    • Acute adrenal insufficiency or adrenal crisis, which can potentially be fatal or life-threatening, can occur in patients with underlying adrenal insufficiency who are on inadequate daily glucocorticoid doses, especially in situations associated with increased cortisol need (e.g., acute intercurrent illness, serious trauma, surgical procedures)
    • Any adjustment of daily glucocorticoid dosage after initiation should be performed with clinician supervision
    • Use glucocorticoid stress doses in case of increased cortisol need (e.g., acute intercurrent illness, serious trauma, surgical procedures)
• Drug interaction overview
  • Crinecerfont is a CYP3A4 substrate
    • Strong or moderate CYP3A4 inducers
    • Modify crinecerfont dose
    • Strong inducers: Increase crinecerfont morning and evening doses 2-fold if coadministered
  • Moderate inducers: Increase crinecerfont evening dose 2-fold if coadministered; do not increase the morning dose

Pregnancy and Lactation

• Available data from reports of pregnancy in clinical trials with crinecerfont are insufficient to identify the drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Lactation
  • Data are not available regarding the presence of crinecerfont in human milk, its effects on breastfed infants, or milk production
  • Crinecerfont is present in animal milk; when a drug is present in animal milk, it is likely to be present in human milk
  • Infants exposed to crinecerfont through breast milk should be monitored for signs of adrenal insufficiency (e.g., weakness, decreased feeding, weight loss)
  • Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for crinecerfont and any potential adverse effects on breastfed children from the drug or the underlying maternal condition