How YUVIWEL® (navepegritide) may help

How YUVIWEL®(navepegritide)may help

Brynlyn, 11 years old

Taking YUVIWEL as part of a clinical trial since age 7

The YUVIWEL difference

In a 1-year study of children with achondroplasia:

  • Children getting YUVIWEL grew faster, on average, than those getting placebo (an injection with no medicine)
  • The YUVIWEL group grew 0.6 inches (1.5 centimeters) more per year than the placebo group
    • Children under 5 years of age grew 0.4 inches more per year, while children 5 and over grew 0.7 inches more per year
  • In an ongoing study, children who continued getting YUVIWEL over 2 years maintained their faster rate of growth throughout treatment
YUVIWEL growth chart YUVIWEL growth chart
The YUVIWEL study was made up of 84 children aged 2 to 12. The study measured how many inches a child grew in a year (at the end of 52 weeks). This measurement is called annualized growth velocity (AGV).
YUVIWEL growth chart
YUVIWEL works with your child's body to help them grow faster than without medication.
Use of YUVIWEL is approved based on an improvement in AGV over 1 year.

Ongoing studies are in progress to assess the efficacy and safety of YUVIWEL over a longer period of time. In addition, there is continued monitoring of additional study endpoints of leg bowing, body proportionality, and physical functioning.

YUVIWEL has an established safety profile:

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The most common side effects were vomiting, injection site reactions, pain in the arms and legs, and nausea. Injection site reactions included redness, itching, skin discoloration, bleeding, swelling, bruising, pain, and blistering.
hair growth icon
3% of children treated with YUVIWEL saw an increase in hair growth either near the injection site or on the limbs, back, and shoulders, compared with 0% of children who received placebo. Rotating the site of injection with each dose can reduce this risk.
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  • In the YUVIWEL study, no one stopped treatment because of side effects
  • All injection site reactions were mild. Children experienced less than 1 injection site reaction per 2 years on YUVIWEL, on average
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Starting once-weekly YUVIWEL

Review how to prepare, give, and store YUVIWEL at home.

Get started YUVIWEL eos nominis

Connect with a PAL and register for updates

A Patient Access Liaison (PAL) can provide you with individualized support and education about achondroplasia and treatment with YUVIWEL. Fill out the form below to receive important information about YUVIWEL and connect with a PAL.

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What is YUVIWEL?
YUVIWEL is a prescription medicine used to increase linear growth in children 2 years and older with achondroplasia with open growth plates (epiphyses).

YUVIWEL is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

USE AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

What are the possible side effects of YUVIWEL?
YUVIWEL may cause serious side effects, including risk of low blood pressure. If your child experiences a decrease in blood pressure or symptoms of low blood pressure (dizziness, feeling tired, and/or nausea) while being treated with YUVIWEL, call your child’s healthcare provider.

The most common side effects of YUVIWEL include injection site

What is YUVIWEL?
YUVIWEL is a prescription medicine used to increase linear growth in children 2 years and older with achondroplasia with open growth plates (epiphyses).

YUVIWEL is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

USE AND IMPORTANT SAFETY INFORMATION

What is YUVIWEL?
YUVIWEL is a prescription medicine used to increase linear growth in children 2 years and older with achondroplasia with open growth plates (epiphyses).

YUVIWEL is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of YUVIWEL?

YUVIWEL may cause serious side effects, including risk of low blood pressure. If your child experiences a decrease in blood pressure or symptoms of low blood pressure (dizziness, feeling tired, and/or nausea) while being treated with YUVIWEL, call your child’s healthcare provider.

The most common side effects of YUVIWEL include injection site reactions (redness, itching, skin discoloration, bleeding, swelling, bruising, pain, and blistering).

Before you give YUVIWEL to your child, tell the healthcare provider about all of your child’s medical conditions, including if they:

  • have kidney problems
  • are pregnant or plan to become pregnant. It is not known if YUVIWEL will harm the unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if YUVIWEL passes into breast milk

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

These are not all of the possible side effects of YUVIWEL. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. You may also report side effects to Ascendis Pharma at 1-844-442-7236.

Please see the full Prescribing Information and Patient Information for YUVIWEL.