Vimizim

Vimizim is a prescription medication used to treat patients with mucopolysaccharidosis type IVA, also known as Morquio A syndrome.

Vimizim is a hydrolytic lysosomal glycosaminoglycan-specific enzyme.  It works by correcting a deficiency in lysosomal enzymes, which are normally produced by the body.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Vimizim include fever, vomiting, headache, nausea, abdominal pain, chills, and fatigue.

Vimizim is a prescription medication used to treat patients with mucopolysaccharidosis type IVA, also known as Morquio A syndrome.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Biomarin Pharmaceutical. Inc.

Serious side effects have been reported with Vimizim. See the “Vimizim Precautions” section.

Common side effects of Vimizim include the following:

• fever
• vomiting
• headache
• nausea
• abdominal pain
• chills
• fatigue

This is not a complete list of Vimizim side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Vimizim including the following:

• Anaphylaxis and hypersensitivity reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of anaphylaxis and hypersensitivity reactions:
  • cough
  • throat tightness
  • hives
  • flushing
  • decreased blood pressure
  • rash
  • shortness of breath
  • chest discomfort

• Acute respiratory complications. Patients with a fever or respiratory illness at the time of infusion of Vimizim may be at increased risk of anaphylaxis and hypersensitivity reactions.

Do not take Vimizim if you:

• are allergic to Vimizim or to any of its ingredients 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Vimizim, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Vimizim, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Vimizim or to any of its ingredients
• have a fever
• have a respiratory illness
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Vimizim falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

There is a Morquio A Registry that collects data on pregnancy women with mucopolysaccharidosis type IVA who are treated with Vimizim.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Vimizim crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Vimizim.

Take Vimizim exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• your weight

The recommended dose of Vimizim for the treatment of mucopolysaccharidosis type IVA is 2 mg/kg once weekly as an intravenous infusion given over 3.5 to 4.5 hours.  The infusion rate is based on the total volume administered, as well as the weight of the patient.

If you take too much Vimizim, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Vimizim is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Vimizim at room temperature. Once the product is diluted, it must be used immediately.
• Protect from light.

WARNING: RISK OF ANAPHYLAXIS

Life-threatening anaphylactic reactions have occurred in some patients during Vimizim infusions. Anaphylaxis, presenting as cough, erythema, throat tightness, urticaria, flushing, cyanosis, hypotension, rash, dyspnea, chest discomfort, and gastrointestinal symptoms (e.g., nausea, abdominal pain, retching, and vomiting) in conjunction with urticaria, have been reported to occur during Vimizim infusions, regardless of duration of the course of treatment. Closely observe patients during and after Vimizim administration and be prepared to manage anaphylaxis. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur.  Patients with acute respiratory illness may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions, and require additional monitoring.