Generic Name: alglucerase (al GLOO ser ase)Brand Names: Ceredase
Alglucerase 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.Alglucerase may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, alglucerase is not a cure for this condition.
Alglucerase may also be used for purposes not listed in this medication guide.What is the most important information I should know about Ceredase (alglucerase)?Alglucerase may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, alglucerase is not a cure for this condition. Some people receiving an alglucerase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel itchy, dizzy, light-headed, or have hives, stomach cramps, pain or tightness in your chest, trouble breathing, or swelling of your face, lips, tongue, or throat.
It may still be possible for you to receive alglucerase even after you have had a reaction to it. There are other medications that can be given to you before your alglucerase infusion to help prevent any reaction symptoms.What should I discuss with my health care provider before taking Ceredase (alglucerase)?
Before using alglucerase, tell your doctor if you are allergic to any drugs, or if you have a hormone-related cancer such as prostate cancer. You may need a dose adjustment or special tests to safely take alglucerase.
Alglucerase is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Alglucerase may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Alglucerase is given as an injection through a needle placed into a vein. You will most likely receive this injection in a clinic or hospital setting.The medicine must be given slowly through an IV infusion, and can take up to 2 hours to complete.
Alglucerase is sometimes given 3 times per week at first. Your dosage may be changed to once per week, once every 2 weeks, or once every 4 weks. Follow your doctor's instructions.
Your doctor may also prescribe other medications to help prevent an allergic reaction to alglucerase. Take all of your medications as directed.
You may be shown how to use this medicine at home. Do not inject alglucerase yourself if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
To be sure this medication is helping your condition and not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.If you store this medication at home, keep it in the refrigerator and do not allow it to freeze.
Call your doctor if you miss an appointment for your alglucerase injection or forget to use it at home.
Symptoms of an alglucerase overdose are not known.
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using alglucerase.
It may still be possible for you to receive alglucerase after you have had a reaction to it. There are other medications that can be given to you before your alglucerase infusion to help prevent any reaction symptoms.Call your doctor at once if you have any of these serious side effects:
warmth, redness, or tingly feeling under your skin;
easy bruising or bleeding;
extreme weakness or tired feeling;
swollen belly, stomach discomfort; or
Some of these may be symptoms of your condition and not actual side effects of alglucerase.
Less serious side effects may include:
changes in your menstrual periods;
swelling in your hands or feet;
changes in your sense of smell;
nausea, diarrhea, upset stomach;
fever or chills; or
any burning, itching, or swelling around the IV needle when the medicine is injected.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
There may be other drugs that can interact with alglucerase. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.