Virtually everyone who participated in a VIMIZIM clinical study chose to continue on in an extension study.
Serious and severe reactions are also associated with VIMIZIM. These include hypersensitivity reactions as well as life-threatening allergic reactions (anaphylaxis) with symptoms such as hives, swelling, cough, shortness of breath, and flushing. In 6 clinical trials, 18.7% of people treated with VIMIZIM experienced hypersensitivity reactions, and 7.7% experienced signs and symptoms consistent with anaphylaxis.
As a precautionary measure you should receive medication such as antihistamines before VIMIZIM infusions to reduce the risk of reactions. If a reaction occurs, the infusion should be slowed or stopped and you may be given additional medication. If a severe reaction occurs, the infusion should be stopped immediately and you will receive appropriate medical treatment.
Anaphylaxis can happen as a result of sensitivity to protein-based molecules (like enzymes) when delivered through an IV. Your infusion nurse will check on you while you receive treatment to make sure everything is going well. If you have a reaction, the nurse will stop the infusion immediately and give you medicine to treat the reaction.
Anaphylaxis can occur during any VIMIZIM infusion and up to 3 hours after any infusion. So, it’s important to be aware of how you are feeling after the infusion and once you are home. If you notice any signs that you are having anaphylaxis, call your doctor immediately.
These are not all of the possible side effects with VIMIZIM. Talk to your doctor if you have any symptoms that bother you or that do not go away.
Safety and effectiveness in pediatric patients below 5 years of age has not been established and is currently being evaluated.
What you should tell your doctor before taking VIMIZIM
Before treatment with VIMIZIM, it is important to discuss your medical history with your doctor. Tell your doctor if you are
- Taking any medications
- Allergic to any medicines
- Are pregnant, planning to become pregnant, or are a nursing mother
This information will help your doctor decide if VIMIZIM is right for you.
You should also tell your doctor if you use supplemental oxygen or continuous positive airway pressure. If you do you will need to have it available during your infusion in the event of a sudden reaction, or extreme drowsiness/sleep from antihistamines.
Spinal cord damage may occur due to the natural MPS IVA disease process. Signs of spinal cord injury include back pain, numbness, and paralysis, and loss of bladder and bowel control. Contact your doctor immediately if you develop any of these symptoms.
To report SUSPECTED ADVERSE REACTIONS contact BioMarin Pharmaceutical Inc. at 1-866-906-6100, or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.