Approved Use: CRENESSITY (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH).

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Susan

Why CRENESSITY?

With CRENESSITY, you can expect more from treatment for classic CAH:

  • Improved androgen control, enabling lower steroid doses
  • Steady androgen levels around the clock with twice-daily dosing
  • Tested in the largest clinical study program for a classic CAH treatment
  • Studied in men and women across a wide range of ages

CHOOSE ONE:

I have CAHI am a caregiver

Learn more about the impact of CRENESSITY in adults

Improved androgen controlLower steroid dosesDemonstrated safety profile

In the adult clinical study, lowering androgen levels with CRENESSITY enabled reduced steroid doses

Androgen levels improved substantially

~8×

greater improvement

There was about an 8× greater improvement in adults taking CRENESSITY compared with those taking

See more data
~37×

greater improvement

There was about a 37× greater improvement in adults taking CRENESSITY compared with those taking placeboUnlike androstenedione, the 17-OHP information was assessed differently. Please talk to your doctor about what this means for you.

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Why is androgen management essential?

Androgens such as androstenedione and testosterone are hormones that help regulate growth and reproduction. Having too many can cause symptoms like early puberty, excess hair growth, acne, and fertility issues.

Steroid doses were lowered significantly

~2×

greater reduction

There was about a 2× greater steroid dose reduction in adults taking CRENESSITY compared with those taking placebo

See more data

The majority of adults taking CRENESSITY
were able to lower their steroid doses

63% of adults were able to lower their steroid dose to the range needed just to replace cortisol while androgen levels stayed the same or improved.*

*The cortisol replacement range was 20 mg/day (11 mg/m2/day) hydrocortisone or less (or equivalent doses for prednisone or dexamethasone). A total of 18% of adults taking placebo were able to lower their steroid doses to the range needed just to replace cortisol while androgen levels stayed the same or improved.

CRENESSITY has a demonstrated safety profile in adults

  • Tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain were the most common side effects in adults taking CRENESSITY
  • Most side effects were temporary and mild to moderate in severity†
  • 96% of adults taking CRENESSITY completed the 24-week study
  • †A total of 3% of patients treated with CRENESSITY and no placebo-treated patients discontinued treatment because of adverse reactions of restlessness, apathy, dyspepsia, nausea, and vomiting.

Adrenal insufficiency and crisis are risks of living with CAH that CRENESSITY does not address and can occur when your steroid dose is too low.

In the CAHtalyst™ Adult clinical study, two patients taking CRENESSITY experienced adrenal crisis. No patients on placebo experienced adrenal crisis; however, one did experience adrenal insufficiency.

Please talk to your doctor about how to manage your steroid dosing while taking CRENESSITY.

Acute adrenal crisis can occur in patients with underlying adrenal insufficiency, especially in situations associated with increased cortisol need, such as acute illness, serious trauma, or surgical procedures.

Hear Paul talk about what it was like to start CRENESSITY

Paul shares how CRENESSITY helped change the way he thought about his treatment goals for classic CAH.

Start the conversation about CRENESSITY.

Reach out to your doctor to find out if CRENESSITY might be right for you. Create a customized guide to help start the conversation—whether at an appointment or via phone, email, or patient portal.

About the CRENESSITY clinical study program

CRENESSITY was tested in the largest, most extensive clinical study program of a treatment for classic CAH

The program included two studies of CRENESSITY:

Both CRENESSITY studies were designed to address the priorities of people with CAH. They tested whether CRENESSITY could:

The study in adults included 182 participants aged 18 years and older with classic CAH

  • 122 took CRENESSITY and 60 took placebo.

    At the start of the study, all participants had to be taking hydrocortisone, prednisone, dexamethasone, or a similar steroid at a dose greater than the range needed to replace cortisol.

    The period of the study in which CRENESSITY was compared with placebo (the placebo period) lasted 6 months (24 weeks).

  • After 6 months in the study, the placebo comparison period ended and participants were told whether they had been taking CRENESSITY or placebo.

    Those taking CRENESSITY were given the option to continue.

    Those taking placebo were given the option to switch to CRENESSITY.

  • 174 of the 182 adults (96%) chose to continue on or switch to CRENESSITY. The people who switched were initially in the placebo group.

  • Throughout the study, both groups took daily steroid medication individually needed to replace missing cortisol. Stress dosing is still needed when taking CRENESSITY. Steroid doses were lowered under careful supervision of doctors.

How do I know?

How do I know if my steroid dose is high?

The amount of hydrocortisone (or other steroid) needed to replace the missing cortisol varies from person to person. In the CAHtalyst Adult™ clinical study, hydrocortisone doses above 20 mg/day for an adult of average height and weight were considered above the cortisol replacement range and can be thought of as “high” steroid doses.

20 mg/day hydrocortisone is roughly equivalent to 5 mg/day prednisone and 0.33 mg/day dexamethasone.

Talk to your doctor to learn more about reevaluating your steroid dose after starting on CRENESSITY.

Learn about the study and results in children
“When CRENESSITY came out, it gave me a new opportunity…something to look forward to, like a big change.”
—Paul

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How CRENESSITY works

Please see full Important Safety Information

Approved Uses:
CRENESSITY (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH).

IMPORTANT SAFETY INFORMATION

Do not take CRENESSITY if you:
Are allergic to crinecerfont, or any of the ingredients in CRENESSITY.

CRENESSITY may cause serious side effects, including:
Allergic reactions. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY.

Risk of Sudden Adrenal Insufficiency or Adrenal Crisis with Too Little Glucocorticoid (Steroid) Medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine.

Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions including if you: are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

The most common side effects of CRENESSITY in adults include tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain.

The most common side effects of CRENESSITY in children include headache, stomach pain, tiredness, nasal congestion, and nosebleeds.

These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

Dosage Forms and Strengths: CRENESSITY is available in 50 mg and 100 mg capsules, and as an oral solution of 50 mg/mL.

Please see full Prescribing Information.