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The Safety Of VOXZOGO Was Studied In 2 Robust Clinical Studies

It’s important to know:

  • VOXZOGO may cause serious side effects, including a temporary decrease in blood pressure in some children
  • You can reduce the risk of decreased blood pressure and associated symptoms (dizziness, feeling tired, or nausea) by following these steps in the hour prior to receiving VOXZOGO:
    • Be well fed
    • Be well hydrated

These side effects were observed in children aged 5 to 15.

This table shows the number (n) of patients who experienced the most common side effects seen in more than 10% of VOXZOGO® (vosoritide) patients over 1 year in a clinical trial*

Table listing the most common side effects observed in children aged 5 to 15.

*Includes adverse reactions occurring in over 10% of VOXZOGO patients and more frequently in the VOXZOGO arm with a risk difference of ≥5% (ie, difference of >2 subjects) between treatment arms.
†Injection site reactions occurring more frequently in VOXZOGO-treated subjects than placebo.
‡Includes the preferred terms: gastroenteritis and gastroenteritis, viral.

The overall safety profile of VOXZOGO in children under the age of 5 was similar to that seen in children aged 5 and up.

The most common side effects seen in over 10% of VOXZOGO® (vosoritide) patients under 5 years of age were injection site reactions (86%) and rash (28%).

97% of children aged 5 to 15 (58/60) continued to take VOXZOGO after 1 year§

§1 child discontinued due to injection pain, and 1 child discontinued due to fear of needles.

Learn more about how to give VOXZOGO to your child.

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IMPORTANT SAFETY INFORMATION

What is the most important safety information about VOXZOGO?

  • VOXZOGO may cause serious side effects including a temporary decrease in blood pressure in some patients. To reduce the risk of a decrease in blood pressure and associated symptoms (dizziness, feeling tired, or nausea), patients should eat a meal and drink 8 to 10 ounces of fluid within 1 hour before receiving VOXZOGO.

What are the most common side effects of VOXZOGO?

  • The most common side effects of VOXZOGO include injection site reactions (including redness, itching, swelling, bruising, rash, hives, and injection site pain), high levels of blood alkaline phosphatase shown in blood tests, vomiting, joint pain, decreased blood pressure, and stomach ache. These are not all the possible side effects of VOXZOGO. Ask your healthcare provider for medical advice about side effects, and about any side effects that bother the patient or that do not go away.

How is VOXZOGO taken?

  • VOXZOGO is taken daily as an injection given under the skin, administered by a caregiver after a healthcare provider determines the caregiver is able to administer VOXZOGO. Do not try to inject VOXZOGO until you have been shown the right way by your healthcare provider. VOXZOGO is supplied with Instructions for Use that describe the steps for preparing, injecting, and disposing VOXZOGO. Caregivers should review the Instructions for Use for guidance and any time they receive a refill of VOXZOGO in case any changes have been made.
  • Inject VOXZOGO 1 time every day, at about the same time each day. If a dose of VOXZOGO is missed, it can be given within 12 hours from the missed dose. After 12 hours, skip the missed dose and administer the next daily dose as usual.
  • The dose of VOXZOGO is based on body weight. Your healthcare provider will adjust the dose based on changes in weight following regular check-ups.
  • Your healthcare provider will monitor the patient’s growth and tell you when to stop taking VOXZOGO if they determine the patient is no longer able to grow. Stop administering VOXZOGO if instructed by your healthcare provider.

What should you tell the doctor before or during taking VOXZOGO?

  • Tell your doctor about all of the patient’s medical conditions including
    • If the patient has heart disease (cardiac or vascular disease), or if the patient is on blood pressure medicine (anti-hypertensive medicine).
    • If the patient has kidney problems or renal impairment.
    • If the patient is pregnant or plans to become pregnant. It is not known if VOXZOGO will harm the unborn baby.
    • If the patient is breastfeeding or plans to breastfeed. It is not known if VOXZOGO passes into breast milk.
  • Tell your doctor about all of the medicines the patient takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

You may report side effects to BioMarin at 1-866-906-6100. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see additional safety information in the full Prescribing Information and Patient Information.

What is VOXZOGO used for?

  • VOXZOGO is a prescription medicine used to increase linear growth in children with achondroplasia and open growth plates (epiphyses).
  • VOXZOGO is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.