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.
