What is the most important information I should know about vosoritide?
Use only as directed. Tell the doctor if your child uses other medicines or has other medical conditions or allergies.
What is vosoritide?
Vosoritide is used to help in growth in children with achondroplasia (a type of rare genetic bone disorder) who are 5 years and older whose bones are still growing.
Vosoritide may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using vosoritide?
Tell the doctor if your child has:
- kidney problems.
Tell the doctor if your teenage child is pregnant or breastfeeding.
Talk to the doctor about the best way to feed your child's baby if your child is using vosoritide.
How is this drug given?
Follow all directions on the prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Doses are based on weight. Your child's dose may change if the child gains or loses weight.
Vosoritide is injected under the skin, once per day, at about the same time each day. A healthcare provider may teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with the medicine. Ask the doctor or pharmacist if you don't understand how to use an injection.
Prepare an injection only when you are ready to give it. Call the pharmacist if the medicine looks cloudy, has changed colors or has particles in it.
Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
Store vosoritide in the refrigerator. Protect from light and do not freeze.
You may store vosoritide (before mixing) at room temperature for 90 days. Throw away any unused medicine after 90 days.
Do not return vosoritide to the refrigerator after it has been stored at room temperature.
What happens if I miss a dose?
Your child should use the medicine as soon as he or she can, but should skip the missed dose if he or she is more than 12 hours late for the dose. Your child should not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using vosoritide?
Follow the doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of vosoritide?
Get emergency medical help if your child has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.
Your child's blood pressure may get low. Your child should eat a meal and drink about 8 to 10 ounces of fluid within 1 hour before receiving vosoritide.
Common side effects may include:
- pain, bruising, swelling, or irritation where the medicine was injected;
- vomiting, stomach pain;
- joint pain; or
- dizziness, tiredness, or nausea.
This is not a complete list of side effects and others may occur. Call the doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect vosoritide?
Other drugs may affect vosoritide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell the doctor about all other medicines your child uses.
Where can I get more information?
The doctor or pharmacist can provide more information about vosoritide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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