WEBVTT

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I've been on
CRENESSITY for about two and a half years

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and it's helped better manage my CAH.

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So before CRENESSITY, I was constantly
going back and forth to my endocrinologist,

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and it was really frustrating.

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So even from before

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I went to medical school,
like all doctors

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had been able to treat
CAH with is steroids.

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And as you know, often times in CAH

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you need high doses of steroids
to get the ACTH and androgen levels low enough.

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As you know, you know, the high dose
steroids are associated

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with so many side effects,
you know, such as, low

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bone density and high blood pressure
and high cholesterol.

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Even with high dose steroids though,
lots of times

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we would still have issues
with high ACTH and androgen levels.

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And I know, as you experienced,
you know, doctors were just

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playing catch up all the time, you know,
having to increase the steroids

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if the androgens were high.

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But how is CRENESSITY different?

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So CRENESSITY is actually
a non glucocorticoid,

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a nonsteroid.
It’s the first nonsteroid medicine

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we've been able to use.

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CRENESSITY works by impacting the HPA axis.

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It decreases those ACTH levels,

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and then that leads to decreased
androgen levels from the adrenal glands.

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Could you explain to me again

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what the HPA axis is?

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Sure, so the hypothalamic pituitary adrenal axis

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makes a lot of hormones
that are like signals that tell your body

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how to deal with stress and growth
and that sort of thing.

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Ok, that makes sense.

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Could you explain to me
how CRENESSITY works

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with the HPA axis?

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Absolutely, so, as you can see here,

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the hypothalamus is supposed to send

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the signal CRF to the pituitary

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where it binds like a
lock and key to its receptor of CRF 1.

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How CRENESSITY works is that it
binds the CRF 1

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and it prevents
CRF from binding to its receptor

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and by doing that it
prevents the pituitary

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from sending all this ACTH out
throughout the body.

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So how does that lower my androgen levels?

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So ACTH is like the on switch

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for your adrenals and your adrenals,

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you know, in patients with CAH,

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they are supposed
to make cortisol and androgens

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but because of the problem

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with the enzyme that makes cortisol
you can't make cortisol.

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So instead you just make all these excess
androgens. By decreasing the amount of ACTH

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in the body, CRENESSITY decreases
the on signal to the adrenal glands.

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So you end up making a lot
fewer androgens.

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Now I understand. And CRENESSITY provides
a different way to manage

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androgen levels
to allow lower doses of steroids.

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Absolutely.

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CRENESSITY is the first FDA approved

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nonsteroid treatment for CAH
that decreases the production of ACTH,

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the signal that leads to excess androgens.

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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.