IMPORTANT SAFETY INFORMATION
WARNING: Life-threatening allergic reactions have occurred in some patients during VIMIZIM® (elosulfase alfa) infusions and up to 3 hours after infusion. Patients with acute respiratory illness may be at increased risk and require additional monitoring.

Virtually everyone who participated in a VIMIZIM clinical study chose to continue on in an extension study.

In a clinical trial, people who received VIMIZIM® (elosulfase alfa) experienced a range of side effects.

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.

If you have a respiratory illness, it may become worse due to a hypersensitivity reaction, and you may require additional monitoring by your nurse.

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.

Talk to your doctor about VIMIZIM.

How well does VIMIZIM work?

Indication

VIMIZIM® (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).

Important Safety Information

Life-threatening allergic reactions, known as anaphylaxis, can occur during VIMIZIM® (elosulfase alfa) infusions. Typical signs of anaphylaxis include cough, rash, throat tightness, hives, flushing, changes in skin color, low blood pressure, shortness of breath, chest pain, and gastrointestinal symptoms such as nausea, abdominal pain, retching, and vomiting. Contact your doctor or get medical help right away if these symptoms occur during or after VIMIZIM infusions. If you have a respiratory illness, you may be at risk for a sudden worsening of your condition, and you may require additional monitoring.

VIMIZIM is a prescription medicine. Before treatment with VIMIZIM, it is important to discuss your medical history with your doctor. Tell your doctor if you are sick or taking any medication and if you are allergic to any medicines. Also tell your doctor if you are pregnant, planning to become pregnant, or are a nursing mother. Your doctor will decide if VIMIZIM is right for you. If you have questions or would like more information about VIMIZIM, contact your doctor.

Anaphylaxis can occur during any VIMIZIM infusion and up to three hours after any infusion, and hypersensitivity reactions have been observed as early as 30 minutes from the start of infusion but as late as six days after infusion.

Serious and severe reactions can happen with VIMIZIM treatment, including life-threatening allergic reactions (anaphylaxis), hives, swelling, cough, shortness of breath, and flushing. 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.

If you have acute febrile or respiratory illness at the time of VIMIZIM infusion you may be at higher risk of life-threatening complications from hypersensitivity reactions. If you use supplemental oxygen or continuous positive airway pressure (CPAP) you should 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.

The most common side effects reported during VIMIZIM infusions included fever, vomiting, headache, nausea, abdominal pain, chills, and fatigue. 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For more information, call BioMarin RareConnections™ at 1-866-906-6100.

CONTACT US

BioMarin Pharmaceutical Inc.

Novato, CA 94949

BioMarin RareConnections™: 1-866-906-6100

Biomarin