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VOXZOGO safety data

FDA approved to start as early as birth and studied over time

Children 5 to 15 years old

Below are the most common side effects seen in over 10% of children (aged 5 to 15 years) on VOXZOGO over 1 year in a clinical trial.*

Table comparing VOXZOGO vs placebo side effects in clinical trials, including injection site reactions and vomiting

In ongoing studies of VOXZOGO, the side effects observed for up to 6 years of treatment are similar to those seen in the first year.

It’s important to know:

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

*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.

Children under 5 years old

The safety of VOXZOGO in children under 5 years old was similar to that seen in children ages 5 years and older.

Over 1 year, the most common side effects seen in over 10% of children on VOXZOGO (under 5 years old) were injection site reactions (86%) and rash (28%).

In ongoing studies of VOXZOGO, the side effects observed for up to 4 years of treatment (see table below) are similar to those seen in the first year.

Table of VOXZOGO side effects at 4 years of treatment in 67 children, including total, serious, and common side effects

In children who started treatment at 4 months to under 2 years old,
the side effects observed after 4 years of treatment were similar
to those seen in children who started treatment at age 2 years or older.

*Data combined from children under 2 years old and 2 to under 5 years old at the start of treatment in clinical trials.
†None of the hypersensitivity side effects were severe, medically significant, or life threatening.
‡None of the injection site reaction side effects were moderate, severe, medically significant, or life threatening.

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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.