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Voxzogo

Pronunciation: Vox-zoe-goe
Generic name: vosoritide
Dosage forms: lyophilized powder , for injection, for subcutaneous use
Drug class: Miscellaneous hormones

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 26, 2023.

What is Voxzogo?

Voxzogo (vosoritide) is a C-type natriuretic peptide (CNP) analog that is given by subcutaneous injection and may be used to increase linear bone growth in children with achondroplasia with open bone growth plates (epiphyses).

Achondroplasia affects endochondral bone growth, which is the process during which growing cartilage is systematically replaced with bone tissue to form the growing skeleton. Endochondral bone growth occurs in over 90% of bones in the body. In children with achondroplasia, bone growth is impaired because of an imbalance in the relationship between fibroblast growth factor receptor 3 (FGFR3) and CNP signaling pathways within the cells of the growth plate. FGFR3 slows bone growth while CNP promotes bone growth. Voxzogo works by stimulating CNP, improving the balance between FGFR3 and CNP, and increasing bone growth in children with open growth plates.

Voxzogo was approved on November 19, 2021, under the accelerated approval criteria for children with achondroplasia with open epiphyses. This criterion is dependent upon continued benefit being shown in clinical trials.

Warnings

May cause a temporary decrease in blood pressure, with symptoms such as dizziness, fatigue, or nausea. Children on antihypertensive medicines may be more at risk. To reduce the risk of low blood pressure, make sure your child is well-hydrated and has had enough food before you administer the infection.

Not recommended in children with renal impairment (eGFR <60 mL/min/1.73 m2).

Before giving your child Voxzogo

Before you give your child Voxzogo, tell your child’s healthcare provider about all your child’s medical conditions, including if they have kidney problems or there is a chance they could become pregnant, are pregnant, or are breastfeeding.

How is Voxzogo administered, given, or used?

To reduce the risk of low blood pressure ensure your child:

The recommended dosage is based on your child’s actual body weight. Your healthcare provider will calculate the dosage and volume to administer for you.

Your healthcare provider will also give you instructions about the right way to store, prepare, and give Voxzogo injections at home. Do not try to inject it until you have been shown the right way to do so.

Your doctor will monitor and assess your child’s body weight, growth, and physical development regularly every 3 to 6 months and adjust the dosage accordingly.

Voxgogo should be stopped once your healthcare provider has confirmed there is no further growth potential, as indicated by the closure of the growth plates.

Detailed Voxzogo dosage information

Instructions for use for Voxzogo

  1. Take the Voxzogo vial and prefilled diluent syringe out of the refrigerator, place them on a clean bench, and allow them to reach room temperature (approximately 15 minutes).
  2. Wash your hands with soap and water.
  3. Inspect the vial and supplies for any signs of damage or contamination. Do not use if damaged or contaminated. Check the expiration date. Do not use it if expired.
  4. Flip the cap off the vial and wipe the top with an alcohol pad. Snap the cap off the prefilled diluent syringe.
  5. Twist the diluent needle onto the prefilled diluent syringe, pull off the needle cap, and insert the needle through the middle of the vial stopper. Slowly push the plunger until all of the liquid is injected into the vial.
  6. Remove the needle from the vial then press the blue tab on the needle to retract the needle. Through the used syringe and needle into a sharps bin.
  7. Gently swirl the vial until all the powder has been completely dissolved and the solution is clear. Do not shake.
  8. Take the injection syringe out of the carton, take off the needle cap, and insert the needle into the vial. Carefully hold the vial and syringe upside down and slowly pull back on the plunger to remove the exact quantity of reconstituted solution to draw up. You can remove large air bubbles by gently tapping the syringe and pushing the bubbles back into the vial.
  9. Once you have the correct dose in the syringe, remove the vial.
  10. Voxzogo should only be injected into the fatty layer under the skin (subcutaneously) of the thighs, abdomen (but 2 inches away from the belly button), buttocks, or back of the upper arms. After mixing, inject Vozgogo right away. Do not inject through clothes and do not inject the same site 2 times in a row.
  11. Wipe the skin to be injected with an alcohol wipe and allow it to dry. Pinch up the skin, and quickly insert the needle at a 45-degree angle. Release the pinched skin and slowly push the plunger rod all the way down.
  12. Withdraw the needle and throw it away in an approved sharps container. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

After the Injection

Inspect the injection site. If a small amount of bleeding occurs from the injection site, gently press a gauze pad on it for a few seconds or apply a bandage. Do not rub the injection site.

Monitor for signs of low blood pressure, such as dizziness, tiredness, and nausea. If your child experiences these symptoms you should call your child’s healthcare provider, then get your child to lay back with legs raised.

What happens if I miss a dose?

If your child misses a dose of Voxzogo, it can be given within 12 hours of the scheduled time of injection. If more than 12 hours have passed, do not give the missed dose. Give the next daily dose according to your child’s usual schedule.

What happens if I overdose?

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

What are the side effects of Voxzogo?

Voxzogo may cause serious side effects, including temporary low blood pressure.

The most common side effects include:

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Voxzogo side effects (more detail)

What other drugs will affect Voxzogo?

Tell your child’s healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Studies have shown that Voxzogo does not inhibit or induce cytochrome p450 enzymes but no studies investigating the drug-drug interaction potential of vosoritide have been conducted.

Know the medicines your child takes. Keep a list of them to show your child’s healthcare provider and pharmacist when your child gets a new medicine.

Voxzogo drug interactions (more detail)

Storage

Store the unopened vial and prefilled diluent syringe in the refrigerator between 36°F to 46°F (2°C to 8°C).

Voxzogo may be stored unopened out of the refrigerator at room temperature between 68°F to 77°F (20°C to 25°C) for 90 days.

Record the date you took it out of the refrigerator.

Do not return it to the refrigerator after it has been stored at room temperature. Throw it away if it remains unused within 90 days of storing it at room temperature.

Do not freeze. Store out of direct sunlight. Do not use past the expiration date.

Keep Voxzogo and all medicines out of the reach of children

Ingredients

Active ingredient: vosoritide 0.4 mg, 0.56 mg, or 1.2 mg.

Inactive ingredients: trehalose dihydrate, mannitol, sodium citrate dihydrate, methionine, citric acid monohydrate, and polysorbate 80.

Manufacturer

BioMarin Pharmaceuticals Inc.

References

  1. Product Label

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer