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 healthcare provider will monitor you closely for symptoms of an allergic
reaction while you are receiving MEPSEVII and for 60 minutes after your infusion.
-
Your healthcare provider will immediately discontinue the MEPSEVII infusion if you
experience anaphylaxis.
- Your healthcare provider should talk to you about the signs and symptoms of
anaphylaxis and about getting medical treatment if you have symptoms.
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 healthcare provider 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 healthcare provider about the best way
to feed your baby while you receive MEPSEVII.
These are not all the possible side effects of MEPSEVII. Call your healthcare provider 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.
