Ceredase

DRUG DESCRIPTION

Ceredase® (alglucerase injection) is a modified form of the enzyme, ?-glucocerebrosidase (?-Dglucosyl-N-acylsphingosine glucohydrolase, EC 3.2.1.45). Alglucerase is a monomeric glycoprotein of 497 amino acids with carbohydrates making up approximately 6% of the molecule (Mr = 59,300 as determined by SDS-PAGE). The unmodified enzyme (?-glucocerebrosidase) also contains 497 amino acids and contains approximately 12% carbohydrate (Mr = 67,000). The carbohydrates on the unmodified enzyme consist of N-linked carbohydrate chains of the complex and high mannose type. Glucocerebrosidase and alglucerase catalyze the hydrolysis of the glycolipid, glucocerebroside, within the lysosomes of the reticuloendothelial system.

Alglucerase is prepared by modification of the oligosaccharide chains of human ?-glucocerebrosidase. The modification alters the sugar residues at the non-reducing ends of the oligosaccharide chains of the glycoprotein so that they are predominantly terminated with mannose residues which are specifically recognized by carbohydrate receptors on macrophage cells.

Ceredase® (alglucerase injection) is supplied as a clear sterile non-pyrogenic solution of alglucerase in a citrate buffered solution (53 mM citrate, 143 mM sodium) containing 1% albumin human USP. The enzyme is supplied in one concentration, 400 units per bottle (80 units/mL) with a fill volume of 5 mL per bottle. An enzyme unit (U) is defined as the amount of enzyme required to hydrolyze in one minute one micromole of the synthetic substrate, p-nitrophenyl-?-D-glucopyranoside.

Ceredase® (alglucerase injection) is purified from a large pool of human placental tissue collected from selected donors. Steps have been introduced into the manufacturing process to reduce further the risk of viral contamination. However, no procedure has been shown to be totally effective in removing viral infectivity. (See PRECAUTIONS). Each lot of product has been tested and found negative for hepatitis B surface antigen (HBsAg) and for human immunodeficiency virus antigen (HIV-1) and antibody (HIV-1/2).

Human chorionic gonadotropin (hCG) is a naturally occurring hormone in human placenta. It is likely the hCG is partially deglycosylated. In vitro studies have previously demonstrated biological activity of approximately 3 units of hCG activity per unit Ceredase® (alglucerase injection) , as determined by an in vitrocell based assay. New process steps have since been introduced into the manufacturing process that significantly reduce the amount of hCG present in the Ceredase® (alglucerase injection) product. Initial manufacturing data indicate that the resulting level of hCG in the product is less than 1 ?µg hCG per mg Ceredase® (alglucerase injection) protein, as determined by the ELISA assay. These data indicate that the level of hCG in the product has been reduced about 15 fold as a result of the new process steps.

What are the possible side effects of alglucerase (Ceredase)?

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 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...

Read All Potential Side Effects and See Pictures of Ceredase »


Ceredase Patient Information Including Side Effects

Brand Names: Ceredase

Generic Name: alglucerase (Pronunciation: al GLOO ser ase)

  • What is alglucerase (Ceredase)?
  • What are the possible side effects of alglucerase (Ceredase)?
  • What is the most important information I should know about alglucerase (Ceredase)?
  • What should I discuss with my health care provider before taking alglucerase (Ceredase)?
  • How is alglucerase given (Ceredase)?
  • What happens if I miss a dose (Ceredase)?
  • What happens if I overdose (Ceredase)?
  • What should I avoid while taking alglucerase (Ceredase)?
  • What other drugs will affect alglucerase (Ceredase)?
  • Where can I get more information?

What is alglucerase (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 are the possible side effects of alglucerase (Ceredase)?

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 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:

  • mouth sores;
  • warmth, redness, or tingly feeling under your skin;
  • easy bruising or bleeding;
  • extreme weakness or tired feeling;
  • swollen belly, stomach discomfort; or
  • pale skin.

Some of these may be symptoms of your condition and not actual side effects of alglucerase.

Less serious side effects may include:

  • hot flashes;
  • changes in your menstrual periods;
  • headache;
  • back pain;
  • 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.

What is the most important information I should know about alglucerase (Ceredase)?

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.

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