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.

Talking to your doctor about VIMIZIM

The next time you see your doctor, bring these questions about VIMIZIM® (elosulfase alfa) with you so you can learn more about treatments, effects, and infusions. Think of these as starter questions, and feel free to come up with some of your own.

  • Why do the “International Guidelines for the Management and Treatment of Morquio A Syndrome” recommend starting enzyme replacement therapy as soon as possible after diagnosis?
  • How does VIMIZIM work?
  • How does VIMIZIM fit in to my overall management plan?
  • What can I expect to change from VIMIZIM treatment?
  • Why can’t I take VIMIZIM in pill form?
  • How soon will I start to see a difference?
  • Is my child too young for VIMIZIM?
  • Am I too old to get VIMIZIM?
  • I want to take VIMIZIM, but do I really need to get weekly treatments?
  • What are the possible side effects of VIMIZIM?

Talking to your doctor is not always as easy as talking to a friend. Here are some helpful ideas to make your visit to your doctor worthwhile.

Do bring a list of questions. You may have a lot of questions to ask before your first treatment. Your doctor expects this, so don’t be shy about asking.

Don’t wait until the last minute to tell your doctor what you are REALLY worried about. When you are walking out the door is not the time to mention that needles make you nervous. Bring it up right away.

Do ask your doctor to help you understand what you’ve learned from reading or talking to your friends or surfing the Net.

Don’t pretend you understand if you really don’t. If you need added explanation from your doctor, don’t be afraid to ask for it.

Do bring a friend or family member with you to help take notes or ask questions.

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