How YUVIWEL® (navepegritide) may help

YUVIWEL can be part of a treatment plan designed to help your child grow.

  • YUVIWEL is a once-weekly injection
  • You can continue to give your child YUVIWEL until their growth plates close
  • Growth plates are the parts of bones where new growth happens
YUVIWEL leg bones icon YUVIWEL leg bones icon

YUVIWEL results

The YUVIWEL study was made up of children aged 2 to 12. The study measured how many inches a child grew in a year.

  • This measurement is called annualized growth velocity (AGV)

In the study:

  • 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 cm) more per year than the placebo group
YUVIWEL growth chart YUVIWEL growth chart

In studies, YUVIWEL was generally well tolerated:

  • 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
  • All injection site reactions were mild and did not cause any children to stop taking YUVIWEL
  • 3% of children saw an increase in hair growth either near the injection site or on the limbs, back, or shoulders. Rotating the site of injection with each dose can reduce this risk

YUVIWEL Instructions for Use

Watch a step-by-step video on giving your child YUVIWEL at home.

See the video

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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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

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 full Prescribing Information and Patient Information for YUVIWEL.

FDA=Food and Drug Administration.