Vosoritide

Vosoritide

What is Vosoritide?

Vosoritide may also be used for purposes not listed in this medication guide.

Vosoritide side effects

Get emergency medical help if your child is affectedSigns of an allergic reaction: hives; difficult breathing; Swelling of the face, lips, tongue or throat.

Your child's blood pressure may drop. Your child should eat a meal and drink about 8 to 10 ounces of fluids within one hour before receiving vosoritide.

Common side effects of vosoritide may include:

• pain, bruising, swelling, or irritation at the injection site of the drug;

• 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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

Use only as directed. Tell the doctor if your child is taking other medications or has any other medical conditions or allergies.

Before you take this medicine

Tell the doctor if your child has:

• Kidney problems.

Tell your doctor if your teenage child is pregnant or breastfeeding.

Talk to the doctor about how best to feed your child's baby if your child is taking vosoritide.

How is this medication administered?

Follow all instructions on the prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

The dosage depends on weight. Your child's dose may change if the child gains or loses weight.

Vosoritide is injected under the skin once a day at about the same time. A doctor can teach you how to properly use the medication yourself.

Carefully read and follow all instructions for use provided with the medicine. Ask your doctor or pharmacist if you do not know how to use an injection.

Do not prepare an injection until you are ready to give it. Call the pharmacist if the medicine looks cloudy, has changed color, or contains particles.

Do not reuse a needle or syringe. Place them in a puncture-resistant sharps container and dispose of in accordance with 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 can store vosoritide (before mixing) at room temperature for 90 days. Discard any unused medicine after 90 days.

Do not put vosoritide back in the refrigerator after it has been stored at room temperature.

Vosoritide dosage information

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 daily
-Weight 12 to 16 kg: 0.28 mg subcutaneously once daily
-Weight 17 to 21 kg: 0.32 mg subcutaneously once daily
-Weight 22 to 32 kg: 0.4 mg subcutaneously once daily
-Weight 33 to 43 kg: 0.5 mg subcutaneously once daily
-Weight 44 to 59 kg: 0.6 mg subcutaneously once daily
-Weight 60 to 89 kg: 0.7 mg subcutaneously once daily
-Weight at least 90 kg: 0.8 mg subcutaneously once daily

Comments:
-The recommended dosage depends on the actual body weight of the patient.
- This medicine should, if possible, be given at about the same time every day.
-Patient's body weight, growth and physical development should be monitored and assessed regularly every 3 to 6 months; The dosage should be adjusted according to the patient's actual body weight.
-This medication should be permanently discontinued if it is confirmed that there is no further growth potential, as indicated by epiphyseal closure.

Application: To increase linear growth in patients with achondroplasia aged 5 years and over with open epiphyses

What happens if I miss a dose?

Your child should take the medicine as soon as possible, but skip the missed dose if it is more than 12 hours late. Your child should not take two doses at the same time.

What happens if I overdose?

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

What should I avoid when using vosoritide?

Follow the doctor's instructions regarding any food, drink, or activity restrictions.

What other drugs will affect vosoritide?

Other medications can affect vosoritide, including prescription and over-the-counter medications, vitamins, and herbal products. Tell the doctor about all other medicines your child is taking.

More information

• Der Arzt oder Apotheker kann Ihnen weitere Informationen zu Vosoritid geben.

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.