Questions I Should Ask My Doctor

Questions I Should Ask My Doctor

As you learn more about MEPSEVII™ (vestronidase alfa-vjbk), you may have more questions.

How does MEPSEVII work?

What steps can I take to prepare for my infusion with MEPSEVII?

What are the potential side effects of MEPSEVII?

Why can’t I take MEPSEVII as a pill?

Am I too old/young for MEPSEVII?

How soon after starting MEPSEVII may I begin to notice a difference?

As you learn more about MEPSEVII™ (vestronidase alfa-vjbk), you may have more questions.

How does MEPSEVII work?

What steps can I take to prepare for my infusion with MEPSEVII?

What are the potential side effects of MEPSEVII?

Why can’t I take MEPSEVII as a pill?

Am I too old/young for MEPSEVII?

How soon after starting MEPSEVII may I begin to notice a difference?

What is MEPSEVII?
MEPSEVII is used to treat children and adults with Mucopolysaccharidosis VII (MPS VII, Sly syndrome). The effect of MEPSEVII on the central nervous system (brain and spinal cord) symptoms of MPS VII has not been determined.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about MEPSEVII?
  • A severe allergic reaction called anaphylaxis has occurred with MEPSEVII treatment, as early as the first dose.
  • Your doctor will monitor you closely for symptoms of an allergic reaction while you are receiving MEPSEVII and for 60 minutes after your injection.
  • Your doctor will immediately discontinue the MEPSEVII infusion if you experience anaphylaxis.
  • Your doctor should talk to you about the signs and symptoms of anaphylaxis and about getting medical treatment if you have symptoms after leaving the doctor’s office or treatment center.
What are the possible side effects of MEPSEVII?
  • The most common side effects of MEPSEVII are:
    • Leakage of MEPSEVII into the surrounding tissue during infusion
    • Diarrhea
    • Rash
    • Severe allergic reaction (anaphylaxis)
    • Infusion site swelling
    • Swelling around the infusion site
    • Severe itching of the skin
  • One patient experienced a seizure during a fever while taking MEPSEVII.
Before receiving MEPSEVII, tell your doctor about all of your medical conditions, including if you:
  • are pregnant, think you may be pregnant, or plan to become pregnant. There is not enough experience to know if MEPSEVII may harm your unborn baby.
  • are breastfeeding or plan to breastfeed. There is not enough experience to know if MEPSEVII passes into your breast milk. Talk with your doctor about the best way to feed your baby while you receive MEPSEVII.

These are not all the possible side effects of MEPSEVII. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Ultragenyx at 1-888-756-8657.

Please see full Prescribing Information for additional Important Safety Information including serious side effects.