Ceredase (Intravenous)

Alglucerase is used to treat Gaucher's disease, which happens because your body does not have enough of a specific enzyme called glucocerebrosidase. This enzyme is important for your body to process fats.

Alglucerase is made from human placenta tissue that is collected after a baby is born. Before it is used, the tissue is tested for hepatitis and human immunodeficiency virus (HIV). This testing is similar to what blood banks do on donated blood before giving it to anyone else.

Alglucerase is available with your doctor's prescription.

It is important that your doctor checks your progress while you are receiving alglucerase to ensure that the dosage is right for you.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it may provide. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare 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.

Pediatric

This medicine has been tested in a small number of children. At effective doses, the medicine has not been shown to cause different side effects or issues than it does in adults.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it is not clear whether they work the same way in older adults as they do in younger adults, or if they cause different side effects or issues in older adults. There is no specific information comparing the use of alglucerase in the elderly with its use in other age groups.

Breast Feeding

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

Interactions with Medicines

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if there is a possibility of interaction. In such cases, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Since alglucerase is made from human tissue, there is a possibility that diseases caused by viruses could be transmitted. Examples of such diseases include hepatitis and HIV infection. However, these issues have not been reported so far and are unlikely because the tissue is tested before use. If you have questions or concerns about this, speak with your doctor.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may occur, but if they do, they might require medical attention.

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your health care professional may have ways to help prevent or reduce some of these side effects. Consult your health care professional if any of the following side effects persist or are bothersome, or if you have any questions about them:

Less common

• Abdominal discomfort
• chills
• fever
• nausea and vomiting
• swelling at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

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

In the U.S.

• Ceredase

Pharmacologic Class: Enzyme

This medicine will not cure Gaucher's disease but it does help control it. Therefore, you must continue to receive it if you expect to keep your condition under control. You may have to receive alglucerase for the rest of your life. If Gaucher's disease is not treated, it can cause serious blood, liver, skeletal, or spleen problems.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For Gaucher's disease: For injection dosage form: Adults and children—The dose is based on body weight. It is injected slowly into a vein over one to two hours. To start, some patients may receive 1.15 Units per kilogram (kg) (0.52 Units per pound) of body weight three times a week. Other patients may receive up to 60 Units per kg (27 Units per pound) of body weight as often as once a week or as seldom as every four weeks. Later, your doctor may raise or lower your dose.