How Do I Start on Treatment?

Getting started on MEPSEVII® (vestronidase alfa-vjbk)

Ultragenyx is committed to patients with MPS VII and their caregivers through UltraCare^®. With UltraCare, Ultragenyx is here to help with everything you need to get started on treatment with MEPSEVII.

LEARN MORE

Ultragenyx is committed to patients with MPS VII and their caregivers through UltraCare^®. With UltraCare, Ultragenyx is here to help with everything you need to get started on treatment with MEPSEVII.

LEARN MORE

How is MEPSEVII taken?

MEPSEVII is given by IV infusion once every other week

The administration takes about 4 hours and will be done at an infusion center, doctor's office, hospital, or at home
Pretreatment with nonsedating antihistamines with or without an antipyretic (medicine used to reduce fever) is recommended 30 to 60 minutes prior to the infusion

A health care professional will supervise the administration and should talk to you about the signs and symptoms of anaphylaxis and also about getting medical treatment if you have symptoms after leaving the doctor's office or treatment center

How is MEPSEVII taken?

MEPSEVII is given by IV infusion once every other week

The administration takes about 4 hours and will be done at an infusion center, doctor's office, hospital, or at home
Pretreatment with nonsedating antihistamines with or without an antipyretic (medicine used to reduce fever) is recommended 30 to 60 minutes prior to the infusion

A health care professional will supervise the administration and should talk to you about the signs and symptoms of anaphylaxis and also about getting medical treatment if you have symptoms after leaving the doctor's office or treatment center

What to expect from infusions

MEPSEVII is given every other week by intravenous (IV) infusion, meaning that the medication is delivered directly into the bloodstream

Infusions with MEPSEVII usually last about 4 hours

Patients receiving MEPSEVII may develop severe allergic reactions (anaphylaxis) occurring during or following the infusion

What to expect from infusions

MEPSEVII is given every other week by intravenous (IV) infusion, meaning that the medication is delivered directly into the bloodstream

Infusions with MEPSEVII usually last about 4 hours

Patients receiving MEPSEVII may develop severe allergic reactions (anaphylaxis) occurring during or following the infusion

How to help prepare for your infusion:

Ask your doctor about preinfusion preparation. Ensure your school/work is aware of your infusion schedule

Stay comfortable by bringing your favorite sweater and/or blanket. Make sure there's a book or activity nearby to keep you entertained

Make sure to get plenty of sleep the night before

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 immediate 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.