YUVIWEL is given as a once-weekly injection under the skin (also called subcutaneous).
Once a week means 313 injection-free days a year.
How to give your child YUVIWEL® (navepegritide)
How to give your child YUVIWEL
YUVIWEL must be carefully mixed and prepared before administering. 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.
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Where to inject YUVIWEL
YUVIWEL should be given in the abdomen (stomach), buttocks, thighs, or back of arms. Please read Instructions for Use before giving YUVIWEL.
- Wash hands before preparing YUVIWEL
- Do not inject in skin that is red, swollen, or scarred
- Rotate injection sites every week
- If the treatment is split between 2 injections, choose 2 different sites
- Keep track of sites from week to week to make sure you are rotating properly
Download the YUVIWEL
Instructions for Use
YUVIWEL administration and storage options
YUVIWEL can be given at any time of day with or without food or drink. There is no need to plan around meals or snacks.
Store unmixed YUVIWEL in a refrigerator. YUVIWEL can also be stored at room temperature (up to 86 °F) for up to 6 months and can be returned to refrigeration within 6 months. YUVIWEL does not contain preservatives.
- After mixing, YUVIWEL can be stored at room temperature and must be used within 4 hours. Throw away unused medicine
It’s important to try to take YUVIWEL the same day each week.
Missed doses:
- YUVIWEL can be given up to 2 days before or 2 days after the scheduled dosing day. Resume once-weekly dosing for the next dose at the usual dosing day
- If more than 2 days have passed from the scheduled dosing day, skip the missed dose and give YUVIWEL on the next regularly scheduled day
- There should be at least 5 days between doses
A•S•A•P text messaging
We’ll send you a text reminder each week
Weekly reminders may be helpful as you get used to giving YUVIWEL to your child.
After talking to your doctor about prescribing YUVIWEL, complete the A•S•A•P consent form below.
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.
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.
FDA=Food and Drug Administration.