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Ceredase is used for:

Treating type I Gaucher disease, an inherited metabolic disorder caused by lack of an enzyme in the body called glucocerebrosidase.

Ceredase is an enzyme. It works by replacing a missing enzyme, which reduces liver and spleen size and improves blood counts.

Do NOT use Ceredase if:

• you are allergic to any ingredient in Ceredase

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ceredase :

Some medical conditions may interact with Ceredase . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have prostate cancer

Some MEDICINES MAY INTERACT with Ceredase . However, no specific interactions with Ceredase are known at this time.

Ask your health care provider if Ceredase may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ceredase :

Use Ceredase as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ceredase is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Ceredase at home, a health care provider will teach you how to use it. Be sure you understand how to use Ceredase . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not shake Ceredase .
• Do not use Ceredase if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Ceredase , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Ceredase .

Important safety information:

• Use Ceredase with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Several months may pass before Ceredase reaches its full effect. Continue to use Ceredase during this time.
• Lab tests, including liver function, kidney function, and blood counts, may be performed while you use Ceredase . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Ceredase with caution in male CHILDREN younger than 10 years old; it may cause early puberty.
• Ceredase should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ceredase while you are pregnant. It is not known if Ceredase is found in breast milk. If you are or will be breast-feeding while you use Ceredase , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ceredase :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Chills; nausea; stomach discomfort.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever; pain, burning, or swelling at the injection site; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Ceredase in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ceredase out of the reach of children and away from pets.

General information:

• If you have any questions about Ceredase , please talk with your doctor, pharmacist, or other health care provider.
• Ceredase is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ceredase . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.