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.

Use only as directed. Tell the doctor if your child uses other medicines or has other medical conditions or allergies.

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.

Usual Pediatric Dose for Achondroplasia:

Administer by subcutaneous injection once daily.

5 years or older:
-Weight 10 to 11 kg: 0.24 mg subcutaneously once a day
-Weight 12 to 16 kg: 0.28 mg subcutaneously once a day
-Weight 17 to 21 kg: 0.32 mg subcutaneously once a day
-Weight 22 to 32 kg: 0.4 mg subcutaneously once a day
-Weight 33 to 43 kg: 0.5 mg subcutaneously once a day
-Weight 44 to 59 kg: 0.6 mg subcutaneously once a day
-Weight 60 to 89 kg: 0.7 mg subcutaneously once a day
-Weight at least 90 kg: 0.8 mg subcutaneously once a day

Comments:
-The recommended dosage is based on the patient's actual body weight.
-This drug should be administered at about the same time each day, if possible.
-Patient body weight, growth, and physical development should be monitored and assessed regularly every 3 to 6 months; dosage should be adjusted according to patient's actual body weight.
-This drug should be permanently discontinued upon confirmation of no further growth potential, indicated by closure of epiphyses.

Use: To increase linear growth in patients with achondroplasia who are 5 years of age and older with open epiphyses

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.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children and away from light. Store vosoritide vials and prefilled diluent syringe in the refrigerator, but do not freeze. Before use, unmixed medication can be stored at room temperature for up to 90 days. Once mixed, use it immediately. It can be stored at room temperature for up to 3 hours after mixing. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow the doctor's instructions about any restrictions on food, beverages, or activity.

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 of vosoritide 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.

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.

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.