Frequently Asked Questions

FrequentlyAskedQuestions

Brynlyn, 11 years old

Taking YUVIWEL as part of a clinical trial since age 7

What is YUVIWEL?
YUVIWEL is a prescription medicine used to increase linear growth in children 2 years of age and older with achondroplasia whose growth plates (epiphyses) are open. 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.
How might YUVIWEL help my child with achondroplasia?
In the 1-year YUVIWEL 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 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 older grew 0.7 inches more per year. Children who continued getting YUVIWEL over 2 years maintained their rate of growth throughout treatment.
Are there any side effects with 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 were vomiting, injection site reactions, pain in arms and legs, and nausea.

YUVIWEL has an established safety profile, and no one stopped treatment because of side effects. All injection site reactions were mild. On average, children experienced less than 1 injection site reaction per 2 years on YUVIWEL.
My child is already on a once-daily CNP treatment. Can we switch to YUVIWEL?
Your child can start once-weekly YUVIWEL the day after their last dose of their daily CNP treatment, so they can switch without missing a treatment day.
Can I give YUVIWEL to my child at home?
Yes. You will be trained by a healthcare professional on how to give YUVIWEL to your child. This Instructions for Use video can help you better understand the process. Ascendis also provides support with free at-home injection training.
How do I give YUVIWEL to my child?
Patients and caregivers should receive appropriate training by a healthcare provider prior to giving YUVIWEL. It is only ever injected right under the skin with the small, thin needle provided in the kit. This is called a subcutaneous injection. It should be injected in the abdomen (stomach, 2 inches from the belly button) or thighs. If given by a caregiver, injection in the buttocks or back of arms is also okay. Do not inject in skin that is red, swollen, or scarred. Rotate injection sites every week. Please refer to the Instructions for Use or ask your healthcare team for complete instructions.

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.

CNP=C-type natriuretic peptide.