Imiglucerase, Injection

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KEY POINTS

• This medicine is given by IV to treat the symptoms of Gaucher disease.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: enzyme replacement therapy

Generic and brand names: imiglucerase, injection; Cerezyme

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat the symptoms of Type 1 Gaucher disease (lack of a certain enzyme). This treatment is called long-term enzyme replacement therapy.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or an immune response to any medicine
• Other treatment for Gaucher’s disease, such as alglucerase (Ceredase)

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

The infusions are given by your healthcare provider. How much medicine you need and how often you receive it depends on how severe the disease is and how you respond to the medicine. Keep all your appointments for the infusions.

What should I watch out for?

This medicine will not cure your disease but will help control it. You may need to take this medicine for the rest of your life.

Rarely, this medicine may cause serious allergic reactions. Signs of an serious allergic reaction may include swelling of your face, tongue, or throat; trouble breathing, swallowing, or talking; shortness of breath or wheezing; chest pain; throat tightness; rash, itching, or hives. You will be monitored closely while you are receiving this medicine. If you experience any signs of an allergic reaction, tell your healthcare provider right away.

Some people may develop antibodies (an immune response) to this medicine during the first year of treatment. This may increase the chance that you will have an allergic reaction. Your healthcare provider may test you periodically for these antibodies. Talk with your healthcare provider about this.

This medicine may cause infusion-related reactions such as headache, dizziness, nausea, tiredness, weakness, or fever. Talk with your healthcare provider about this.

You need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Infusion-related reactions such as headache, dizziness, nausea, unusual tiredness or weakness, fever; fast heartbeat; swelling of your ankles, feet, or hands; cough; shortness of breath.

Other: Discomfort, burning, or swelling at the spot where infusions are given; mild fever or chills; mild dizziness; stomach pain; nausea; vomiting; diarrhea; headache; joint pain; back pain; flushing; itching; mild rash.

What products might interact with this medicine?

No significant interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.