Vosoritide (voe-SOR-i-tide)

Used to increase linear growth in children with achondroplasia (a genetic disorder) and open epiphyses (bones are still growing).

Brand Name(s):

Voxzogo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the lower stomach, middle of the thighs, back of the upper arms, or upper buttocks. Use this medicine at the same time each day.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your child's medicine at home. Make sure you understand all instructions before giving your child an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, swollen, or tender.
• Allow the medicine to warm to room temperature before you mix it.
• Check the medicine after mixing it in the vial. Do not shake. The liquid should be clear and colorless to yellow. Do not use the medicine if it is cloudy, discolored, or has particles in it. Do not save leftover medicine or mix with other medicine. Do not use the vial or prefilled syringe if it is damaged or broken.
• Your child should eat a meal and drink at least 8 to 10 ounces (240 to 300 mL) of water within 1 hour before receiving this medicine.
• Use a new needle and syringe each time you inject your medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose, and it is within 12 hours of the scheduled time of injection, use it as soon as possible. If you miss a dose and it is more than 12 hours, skip the missed dose and use your next dose at the regular time. Do not use extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may store the medicine at room temperature, away from heat and direct light for up to 90 days. Record the start date on the carton. Do not return the medicine into the refrigerator after it has been kept at room temperature. Throw away unused medicine after 90 days.
• After mixing, use it right away. Do not use the mixed liquid if it has been kept at room temperature for more than 3 hours.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease.
• This medicine may increase the risk of low blood pressure.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dizziness, lightheadedness, fainting
• Fever, chills, cough, sore throat, body aches

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, loss of appetite, nausea, vomiting, stomach pain
• Dry skin
• Ear pain
• Joint pain
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088