1 What is Vimizim?

Brand: Vimizim

Generic: Elosulfase Alfa

Vimizim is used to treat patients with mucopolysaccharidosis type A (Morquio A syndrome). This medicine is to be given only by or under the direct supervision of your doctor. This product is available in the following dosage forms.

2 What to Know Before Using

If you are about to start using Vimizim, speak with your doctor about what you need to know.

In the making of the decision on the use of this medicine:

One has to consider the risks of taking the medicine must be weighed against the good it will do. This decision must be reached by you and your doctor. It is also necessary to consider if you have suffered from any form of allergies.

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Studies describing the use of this medicine in children to date have not demonstrated pediatric-specific problems that would limit the usefulness of elosulfase alfa injection in children. However, safety and efficacy have not been established in children younger than 5 years of age.

In adults, although appropriate studies on the relationship of age to the effects of elosulfase alfa injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

In pregnancy, animal studies have shown an adverse effect and there are no adequate studies in pregnant women or no animal studies have been conducted and there are no adequate studies in pregnant women.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.

Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. It is also possible that certain or other interactions may occur when certain medicines are used at or around the time of eating food or eating certain types of food.

Using alcohol or tobacco with certain medicines may also cause interactions to occur. It is necessary to discuss the use of food, alcohol, or tobacco and this medicine with your healthcare professional. The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

Use with caution. May increase risk for more serious side effects.

3 Proper Usage

Proper usage of Vimizim requires strict adherence to your doctor’s orders. A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

The medicine must be injected slowly, so your IV tube will need to stay in place for at least 3.5 to 4.5 hours, once a week. You may also receive medicines to help prevent possible allergic reactions to the injection.

4 Precautions to Take

Before using Vimizim, there are some precautions you must take. Your doctor will check your progress closely while you or your child is receiving this medicine.

This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention.

Call your doctor right away if you or your child has a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

Spinal or cervical cord compression (SCC) may occur while receiving this medicine. Check with your doctor right away if you or your child has back pain, loss of bladder or bowel control, or numbness or weakness in the legs.

5 Potential Side Effects

Make sure you meet with your doctor in using Vimizim to avoid unwanted potential side effects.

Check with your doctor or nurse immediately if any of the following side effects occur:

The more common side effects include:

  • chills
  • cough
  • the difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fever
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • skin rash
  • hives or itching tightness in the chest
  • unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them, more common abdominal or stomach pain headache vomiting.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088