Starter Kit | CRENESSITY® crinecerfont

Adults

Actor portrayal

This Starter Kit is your go-to resource to support your child’s journey with CRENESSITY For Caregivers

What’s Inside

Grant and Kristy’s CRENESSITY Experience ........03-04 Educational Resource Library . .....................................05 Get to Know CRENESSITY for Caregivers.................................................. 05 Get to Know CRENESSITY for Adults..........................................................06 Understanding CAH........................................................................................07 Neurocrine Access Support...........................................................................07 How to Take CRENESSITY.............................................................................08 Planning Your Meals With CRENESSITY....................................................08 Know Your Labs..............................................................................................09 Taking the Next Step With CRENESSITY.....................................................10 Neurocrine Access Support for CRENESSITY . ............ 11 Program Overview..........................................................................................11 Mobile Contact Card.......................................................................................11 Financial Support Options............................................................................12 Getting Involved in the CAH Community.................... 13 Important Safety Information . .................................... 15

TO THINK DIFFERENTLY ABOUT CAH Checking back in with Kristy

Kristy, mom of Grant, a 9-year old living with classic CAH and taking CRENESSITY since 2022

Kristy was compensated by Neurocrine for sharing her story.

Missed the Welcome Video from Kristy? Access it here.

See page 4 for an overview of the results from the CRENESSITY clinical trial in children.

SELECT IMPORTANT SAFETY INFORMATION 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

Please see Full Important Safety Information on last page and Patient Information.

The Impact of CRENESSITY for Grant

“When I saw Grant’s lab results for the very first time, I thought the lab had made a mistake...his androgen levels were significantly lower and I was really excited for him.” -Kristy, Grant’s mom

Kristy is a caregiver of a child with CAH who is taking CRENESSITY, and is a paid partner of CRENESSITY

Before taking CRENESSITY

After 4 weeks of CRENESSITY

80% reduction

Androstenedione

45 ng/dL

9 ng/dL

80% reduction

17-OHP

1252 ng/dL

252 ng/dL

Grant - Living with CAH and taking CRENESSITY

Before taking CRENESSITY

After 28 weeks of CRENESSITY*

~30% reduction

Hydrocortisone

17.5mg/day

12.5mg/day

Honest Stories. Relatable Experiences. Genuine Support. Whether your child is just starting treatment with CRENESSITY or they’ve been taking it for some time, your StarterKit is here to help you feel empowered, supported, and confident in the path ahead. As with any change in treatment, staying informed is important. This StarterKit gives you instant access to a variety of educational resources about CRENESSITY and classic CAH management, to access throughout your child’s CAH treatment journey.

17-OHP = 17-hydroxyprogesterone

The Clinical Studies: A Quick Refresher. In clinical studies, CRENESSITY helped children improve or maintain androgen control, allowing them to lower their steroid doses. In children ages 4 and older: After 4 weeks, androstenedione (androgen) levels dropped by an average of 197 ng/dL with CRENESSITY and increased by 71 ng/dL in those taking placebo. After 28 weeks, steroid doses were reduced by an average of 18% with CRENESSITY and increased by 6% for those taking placebo.

Want a refresher of the brochures in your Welcome Kit? Access digital copies.

SELECT IMPORTANT SAFETY INFORMATION 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.

Please see Full Important Safety Information on last page and Patient Information.

The following is a selection of educational resources about CRENESSITY, CAH, and more—available anytime you need them. Educational Resource Library

Get to Know CRENESSITY for Adults

A comprehensive guide to CRENESSITY for adults, including the results of the clinical study in adults.

Get to Know CRENESSITY for Caregivers

A comprehensive guide for caregivers about CRENESSITY, including dosing, clinical study results in children, safety information, and more.

For caregivers of children with classic CAH Get to Know CRENESSITY The first-ever FDA-approved treatment developed just for people with classic CAH

[no notes on this page]

Please see additional Important Safety Information on page 16 and Patient Information. 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). SELECT IMPORTANT SAFETY INFORMATION Do not take CRENESSITY if you: Are allergic to crinecerfont, or any of the ingredients in CRENESSITY. Approved Uses: CRENESSITY (crinecerfont) is a prescription medicine used together with

- 1 -

Ready to take the next step in your journey with CRENESSITY? Review Know Your Labs and Taking the Next Step and get in touch with your healthcare team—whether at an appointment or via phone, email, or patient portal.

SELECT IMPORTANT SAFETY INFORMATION 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.

Please see Full Important Safety Information on last page and Patient Information.

Understanding CAH A resource that can refresh your memory about the hormone imbalances associated with CAH and walk you through the science of what’s happening in your child’s body.

How to Take CRENESSITY A simple-to-use fact sheet about how and when your child should take CRENESSITY, dosing, and other related information.

Understanding CAH

How to take CRENESSITY TM (crinecerfont) CRENESSITY is taken by mouth twice daily for steady levels around the clock. Twice-daily dosing means androgen levels stay more consistent throughout the day and night. Follow directions from your or your child’s doctor on how to take CRENESSITY.

An overview of the science behind classic CAH and the challenges that come with high-dose steroids

Adults aged 18 years and older take 100 mg twice daily (200 mg total each day). For children and teens, CRENESSITY dosing is based on weight. Explore more below.

Take CRENESSITY with morning and evening meals.

Ask your or your child’s doctor if it’s possible to time steroid doses with CRENESSITY doses.

Take CRENESSITY exactly as your or your child’s doctor tells you to.

Talk to your or your child’s doctor before stopping CRENESSITY

In children and teens, dosing is based on weight

For children, CRENESSITY comes in capsules or as an oral solution (liquid). If prescribed CRENESSITY oral solution, use the oral dosing syringe provided by the pharmacist to measure the correct dose. Refer to the Instructions for Use included with the prescription for more information.

Weight

Neurocrine Access Support Your roadmap to personalized, one-on-one support and financial assistance options available through Neurocrine Access Support.

Take CRENESSITY with a meal

Are you or your child starting CRENESSITY? Neurocrine Access Support is a free, comprehensive program you can count on to provide the support you deserve. Access Simplified Dedicated support, personalized to you

CRENESSITY works best when taken with food containing a bit of fat so the medicine gets into your system the way it needs to. Some examples of food with enough fat include snacks like:

• A granola bar with nuts • Half an avocado • An apple with peanut butter

• A glass of whole milk or chocolate milk (not skim) • A glass of full fat oat milk • Crackers with cheese or peanut butter

A program that puts patients first at every stage of treatment, including:

• Navigating insurance and financial assistance options • Coordinating medication delivery right to your door • Connecting you to the right resources when you need them most

Kristy and Grant

Need to get in touch with your care coordinator or clinical pharmacist? View your mobile contact card to reach them.

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

Please see Full Important Safety Information on last page and Patient Information.

Wherever your child is in their journey, the right support matters. These tools will help guide you and your child through next steps with CRENESSITY—from understanding their lab results to working with your child’s doctor to adjust their care plan. Each resource was created with your child in mind, to help them feel informed, supported, and ready for what’s ahead.

Taking the Next Step With CRENESSITY A brochure that can help prepare you and your child for lowering their steroid dose, if that’s part of their

treatment goal. See five case studies from real people taking CRENESSITY and how they lowered their steroid dose step-by-step under their doctor’s guidance.

Taking the next step with CRENESSITY

Know Your Child’s Labs A guide to the key lab values measured as part of your child’s CAH management plan, why they’re important numbers to know, and how they impact your child’s treatment.

Real people. Different ages. Different steroids.

A guide to your numbers and why they matter

Together with how you feel and what signs and symptoms you’re experiencing, lab values are what doctors use to make decisions about your care. Labs are a valuable tool for you, too. They can help you better understand why you feel the way you feel and can help you get more out of conversations with your doctors. Talk to your doctor about appropriate lab ranges for you.

Essential bloodwork for people with congenital adrenal hyperplasia (CAH)

Blood test

What it measures

Why it’s important

Understanding your results

Discover how they each found a path to lower steroid doses with CRENESSITY

• An indicator of androgen control • Lower levels are associated with better CAH management • Higher levels are associated with acne, early puberty, and fertility issues • High androgen levels may be treated with CRENESSITY (a CRF 1 antagonist) or an increased steroid dose • Similar to androstenedione, 17-OHP is an indirect measure of how well androgen levels are managed • Lower levels are associated with better CAH management • Higher levels may be treated with CRENESSITY (a CRF 1 antagonist) or an increased steroid dose • Testosterone helps support muscle and bone mass. High levels are associated with excess facial hair growth and acne and can cause early puberty in children. • High levels in females are associated with poor CAH management and can cause deepening of the voice and other symptoms, like excess facial hair • Helps measure whether you are getting enough salt and mineralocorticoid (fludrocortisone) • Renin helps maintain a healthy blood pressure and prevent levels of electrolytes that are too low

Levels of the hormone androstenedione, which is an ingredient the body uses to make different androgens. Sometimes abbreviated A4, it also has slight testosterone-like effects in the body.

• Your target range depends on a number of factors including age and gender • For men, the target range for androstenedione is optimally less than half the level of testosterone. Your doctor may refer to this as the “A4 to T ratio”

The profiles in this brochure are based on real experiences from the CAHtalyst™ studies. Names and personal details have been changed. Your or your child’s treatment may differ—even if age or steroid type is the same. Never change steroid doses without talking to your doctor.

Androstenedione (A4)

Levels of 17 OHP, also called 17-hydroxyprogesterone, a hormone that the adrenal glands use to make androgens.

• Target range is based on a number of factors. If CAH is treated with steroids alone, values in the “normal” range of your lab report may suggest that steroid doses are too high

17-0HP

Please see additional Important Safety Information on page 6 and Patient Information .

• In females, total testosterone higher than the upper limit of normal indicates poor CAH management • In males, the ratio of androstenedione to testosterone (A4 to T, or A4/T) helps determine whether CAH is well managed • Target range is low to normal unless you have high blood pressure • Elevated renin levels suggest that salt and/or mineralocorticoid (fludrocortisone) doses, or water intake, may be too low • Low, or suppressed, renin suggests that the dose of salt and/or fludrocortisone may be too high

Testosterone (T)

Levels of the hormone testosterone, an androgen.

Levels of renin, which the body releases into the bloodstream when electrolyte (salt) levels are too low or you are dehydrated.

Plasma renin activity (PRA)

CRF 1 =corticotropin-releasing factor receptor 1.

CRENESSITY TM (crinecerfont) is the first and only FDA-approved CRF 1 antagonist to treat classic CAH. Learn more at CRENESSITY.com

Would you like to inform and encourage other caregivers for those starting or continuing their CRENESSITY journey? Begin your application now!

SELECT IMPORTANT SAFETY INFORMATION 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.

Please see Full Important Safety Information on last page and Patient Information.

Neurocrine Access Support provides more than just help with your child’s medication. It’s a comprehensive program designed to ensure your child has have everything they need to begin and continue taking CRENESSITY. As part of the program, a dedicated Care Coordinator will walk you and your child through everything you need to know. Dedicated support, personalized to you and your child

Your guide to our financial support options

CRENESSITY Savings Program You can expect to pay $0 out of pocket for your child’s CRENESSITY prescription if you have commercial insurance.*

My Child’s Insurance Has Changed We will help to ensure there is no disruption in receiving your child’s CRENESSITY medication.* To help ensure continued access to CRENESSITY, it’s important to let your child’s Care Coordinator know if your insurance situation changes.

Here’s how your Care Coordinator will help: • Understanding your insurance and financial assistance options • Communicating with the pharmacy • Coordinating your prescription delivery • Providing ongoing support

* Additional terms and conditions apply.

We’re always just a phone call away. Our Care Coordinators are available from 8 AM to 8 PM ET, Monday through Friday at 1-855-CRNSITY (276-7489) .

Click here to save our phone number and visit NBIaccess.com/cft-pt for more information.

Kristy and Grant

Please see Full Important Safety Information on last page and Patient Information.

JOIN OUR AMBASSADOR PROGRAM

THIS IS YOUR OPPORTUNITY TO HELP OTHERS LIVING WITH CAH AND THEIR CAREGIVERS As a CRENESSITY Patient or Caregiver Ambassador, you can help others living with classic congenital adrenal hyperplasia (CAH) by sharing your unique experiences and perspective. You’ll educate, encourage, and inspire others in the CAH community. As CAH is a rare condition, it’s more important than ever to have people willing to share their lived experiences to educate others. YOUR STORY, YOUR WAY How you participate is completely up to you. Share your experience with the CAH community and healthcare professionals who treat CAH in a way of your choosing, whether it be in front of a live audience or through more private engagements. The program offers a variety of activities that participants can decide to participate in, including:

TO EMPOWER OTHERS BY SHARING YOUR CAH STORY WITH THE COMMUNITY

Educational Support Sharing your experience to help others understand CAH and treatment options

Story Sharing Participating in marketing materials and awareness campaigns

Digital Advocacy Creating social media content and engaging with the online CAH community

Video Content Creation Participating in educational videos, testimonials, and video interviews

CRENESSITY Ambassadors

Promotional Collaboration Appearing in branded materials, advertisements, and website content

Peer Connection Providing one-on-one support and mentoring others in the CAH community

Join Our Ambassador Program

Community Leadership Representing the CAH community at events and speaking engagements

We’d love to hear your story! Please follow the link below to submit your information to our team at the Ambassador Program. A member of our team will reach out to you to share more information about the program, while also scheduling time to get to know you more.

Best of all, you can decide how often you want to participate, from monthly events to just a few times a year!

Share Your Story Today!

Check Out Our Upcoming Events

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

Please see Full Important Safety Information on last page and Patient 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 Patient Information.

Page 1 Page 2-3 Page 4-5 Page 6-7 Page 8-9 Page 10-11 Page 12-13 Page 14-15 Page 16

Made with FlippingBook - Online catalogs