Cerezyme is a man-made form of an enzyme that occurs naturally in the body. It is used as an enzyme replacement in people with Type I Gaucher disease.

Gaucher disease is a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials (lipids). Lipids can build up in the body, causing symptoms such as easy bruising or bleeding, weakness, anemia, bone or joint pain, enlarged liver or spleen, or weakened bones that are easily fractured.

Cerezyme may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, this medicine is not a cure for this condition.

Cerezyme may also be used for purposes other than those listed in this medication guide.

Symptoms of allergic reactions including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; hives; itching; flushing; and dizziness or fainting, have occurred with the use of Cerezyme. Approximately 15% of patients treated with Cerezyme develop antibodies to imiglucerase. Approximately 46% of patients with detectable antibodies have experienced an allergic reaction. Emergency medical attention may be required if an allergic reaction is experienced.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Cerezyme is injected into a vein through an IV. A healthcare provider will give you this injection.

Cerezyme is usually given every 2 weeks, but you may need the medicine more often when you first start using it. Follow your doctor's dosing instructions very carefully.

You may be given other medicines to prevent certain side effects of Cerezyme. Take these medicines exactly as directed.

Tell your doctor if you have any changes in weight. Cerezyme doses are based on weight.

Usual Adult Dose for Gaucher Disease:

Initial dosage: ranges from 2.5 units/kg of body weight 3 times a week to 60 units/kg once every 2 weeks. Imiglucerase for injection is administered by intravenous infusion over 1 to 2 hours.

Dosage should be individualized to each patient. Disease severity may dictate that treatment be initiated at a relatively high dose or relatively frequent administration.

Usual Pediatric Dose for Gaucher Disease:

Greater than or equal to 2 years of age:

Initial dosage: ranges from 2.5 units/kg of body weight 3 times a week to 60 units/kg once every 2 weeks. Imiglucerase for injection is administered by intravenous infusion over 1 to 2 hours.

Dosage should be individualized to each patient. Disease severity may dictate that treatment be initiated at a relatively high dose or relatively frequent administration.

You should not use Cerezyme if you are allergic to imiglucerase.

To make sure Cerezyme is safe for you, tell your doctor if you have:

• a breathing problem such as pneumonia or pulmonary hypertension.

FDA pregnancy category C. It is not known whether Cerezyme will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether imiglucerase passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Cerezyme should not be given to a child younger than 2 without a doctor's advice.

Call your doctor for instructions if you miss a dose of Cerezyme.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction to Cerezyme: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or shortly after the injection. Tell your caregiver right away if you feel dizzy, itchy, light-headed, sweaty, or have chest pain, cough, trouble breathing, or flushing (warmth, redness, or tingly feeling).

Call your doctor at once if you have:

• fever, chills, cough with yellow or green mucus;

• stabbing chest pain, wheezing, feeling short of breath; or

• worsening or no improvement in your Gaucher disease symptoms.

Common Cerezyme side effects may include:

• stomach pain, nausea, vomiting, diarrhea;

• fast heartbeats;

• headache, dizziness;

• back pain;

• fever, chills, tired feeling;

• mild rash; or

• itching, burning, swelling, or other discomfort around the IV needle.

Other drugs may interact with imiglucerase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.