Pronunciation:

voe-SOR-i-tide

Brand Names:

• Voxzogo

Dosage Forms:

• Powder for Solution

Classifications:

Pharmacologic—

Natriuretic Peptide

Uses of This Medicine:

Vosoritide injection is used to increase linear growth in children with a genetic disorder called achondroplasia with open epiphyses (bones are still growing).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of vosoritide injection in children. Safety and efficacy have been established.

Older adults—

Vosoritide injection is not indicated for use in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease, severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. Your caregiver may be trained to prepare and inject this medicine at home. It is given as a shot under the skin, usually in the lower stomach, middle of the thighs, back of the upper arms, or upper buttocks. Be sure that 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.

Use this medicine at the same time each day.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions about:

• How to prepare the injection.
• The proper use of the prefilled syringes.
• How to give the injection.
• How long the injection can be stored at home.

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.

If you use vosoritide at home, 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. This will help prevent skin problems. Do not inject into skin areas that are red, swollen, or tender.

Check the medicine in the vial. 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 use the vial or prefilled syringe if it is damaged or broken.

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.

Use a new needle and syringe each time you inject your medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (powder for solution):
  • For linear growth in children with achondroplasia and open epiphyses:
    • Children—Dose is based on body weight and must be determined by your doctor.
      • Weighing 90 kilograms (kg) or more—0.8 milligrams (mg) or 0.4 milliliters (mL) injected under the skin once a day.
      • Weighing 60 kg to 89 kg—0.7 mg or 0.35 mL injected under the skin once a day.
      • Weighing 44 kg to 59 kg—0.6 mg or 0.3 mL injected under the skin once a day.
      • Weighing 33 kg to 43 kg—0.5 mg or 0.25 mL injected under the skin once a day.
      • Weighing 22 kg to 32 kg—0.4 mg or 0.5 mL injected under the skin once a day.
      • Weighing 17 kg to 21 kg—0.32 mg or 0.4 mL injected under the skin once a day.
      • Weighing 12 kg to 16 kg—0.28 mg or 0.35 mL injected under the skin once a day.
      • Weighing 8 kg to 11 kg—0.24 mg or 0.3 mL injected under the skin once a day.
      • Weighing 6 kg to 7 kg—0.2 mg or 0.25 mL injected under the skin once a day.
      • Weighing 5 kg—0.16 mg or 0.2 mL injected under the skin once a day.
      • Weighing 4 kg—0.12 mg or 0.15 mL injected under the skin once a day.
      • Weighing 3 kg—0.096 mg or 0.12 mL injected under the skin once a day.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store 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 where the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may increase risk of low blood pressure. Your doctor may ask you to let your child eat a meal and drink at least 240 to 300 mL of water within 1 hour before receiving this medicine to help reduce this risk. Check with your doctor right away if your child have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

chills

confusion

cough

diarrhea

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches and pains

nausea

runny nose

shivering

sore throat

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty in moving

dry skin

ear pain

feeling of constant movement of self or surroundings

hives, itching, rash, redness, swelling, or warmth at the injection site

muscle pain or stiffness

pain in the joints

sensation of spinning

stomach pain

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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