WEBVTT

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We've been

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talking a lot about CAH
and how CRENESSITY works.

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I want more detail on how CAH affects
the body.

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CRENESSITY works by impacting the HPA axis.

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The HPA axis is the hypothalamic pituitary
adrenal axis,

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and its makes all kinds of hormones.

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And the hormones are like signals that,

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you know, tell your body
how to deal with stress, how to grow.

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It also deals with your metabolism.

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So the HPA axis has three parts?

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That's right.

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So, the HPA axis consists of three glands,

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the hypothalamus and pituitary.

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And the adrenal glands
that sit just above your kidneys.

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And these all make hormones.

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The hypothalamus,
which is like the master control center,

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is like, you know, where is that
cortisol? Make me some cortisol.

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So it sends out
a signal called, corticotropin

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releasing factor CRF that binds to CRF
type one receptors on the pituitary.

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When CRF binds to its receptor
like a lock and key,

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then the pituitary sends out ACTH

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throughout the body.

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So, Dr. Lin,
you talked about two signals,

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CRF and ACTH.

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That's right.

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So CRF is a signal
that the hypothalamus sends the pituitary

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right when the CRF signal goes to the pituitary

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the pituitary releases ACTH
throughout the body.

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What does high ACTH levels do?

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High ACTH levels in the adrenal glands

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act like an on switch.

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The adrenal glands act like an assembly line
that's supposed to make

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a bunch of hormones,

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one of which is cortisol.

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And CAH affects
some of these signals, right?

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Absolutely.

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As you know, in CAH, the enzyme that
you need to make cortisol doesn't work.

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So, what happens
is that the adrenal glands end up

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making all these androgens instead,
like way more than you need.

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Ok, that makes sense.

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My adrenal glands are making more androgens,
way more than I need.

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And CRENESSITY provides
a different way to manage

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androgen levels
to allow lower doses of steroids.

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That's absolutely correct.

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Now, I understand
how CAH affects hormones.

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Important safety information.

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Approved uses.

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CRENESSITY (crinecerfont)

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is a prescription medicine used together
with glucocorticoids (steroids) to control

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androgen (testosterone-like hormone) levels
in adults and children, 4 years of age

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and older with classic congenital
adrenal hyperplasia (CAH).

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Important safety information.

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Do not take CRENESSITY

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if you are allergic to crinecerfont,
or any of the ingredients in CRENESSITY.

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CRENESSITY may cause serious side effects,
including: Allergic reactions:

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Symptoms of an allergic reaction
include tightness of the throat,

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trouble breathing or swallowing, swelling
of the lips, tongue, or face, and rash.

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If you have an allergic reaction
to CRENESSITY, get emergency

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medical help right away
and stop taking CRENESSITY.

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Risk of sudden adrenal insufficiency
or adrenal crisis

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with too little glucocorticoid
(steroid) medicine.

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Sudden adrenal insufficiency
or adrenal crisis can happen in people

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with congenital adrenal hyperplasia

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who are not taking enough
glucocorticoid (steroid) medicine.

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You should continue taking

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your glucocorticoid (steroid) medicine
during treatment with CRENESSITY.

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Certain conditions
such as infection, severe injury, or shock

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may increase your risk for sudden adrenal
insufficiency or adrenal crisis.

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Tell your healthcare provider
if you get a severe injury,

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infection, illness
or have planned surgery during treatment.

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Your healthcare provider may need

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to change your dose
of glucocorticoid (steroid) medicine.

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Before taking CRENESSITY,

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tell your healthcare provider
about all of your medical conditions

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including if you: are pregnant
or plan to become pregnant,

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or are breastfeeding or plan to breastfeed.

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Tell your healthcare provider
about all the medicines you take,

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including prescription

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and over-the-counter medicines, vitamins
and herbal supplements.

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The most common side effects
of CRENESSITY in adults include tiredness,

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headache, dizziness, joint pain, back
pain, decreased appetite, and muscle pain.

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The most common side effects of CRENESSITY
in children include headache, stomach

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pain, tiredness,
nasal congestion, and nosebleeds.

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These are not all the possible side
effects of CRENESSITY.

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Call your healthcare provider
for medical advice about side effects.

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You are encouraged to report negative side
effects of prescription

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drugs to the FDA.

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Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

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Dosage forms and strengths:

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CRENESSITY is available
in 50 mg and 100 mg capsules,

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and as an oral solution of 50 mg/mL.

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Please see the accompanying full
Prescribing Information or find it at

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www.neurocrine.com/crenessityppi.