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(imiglucerase) for injection
Cerezyme® (imiglucerase for injection) is an analogue of the human enzyme β-glucocerebrosidase, produced by recombinant DNA technology. β-Glucocerebrosidase (β-D-glucosyl-N-acylsphingosine glucohydrolase, E.C. 126.96.36.199) is a lysosomal glycoprotein enzyme which catalyzes the hydrolysis of the glycolipid glucocerebroside to glucose and ceramide.
Cerezyme® is produced by recombinant DNA technology using mammalian cell culture (Chinese hamster ovary). Purified imiglucerase is a monomeric glycoprotein of 497 amino acids, containing 4 Nlinked glycosylation sites (Mr = 60,430). Imiglucerase differs from placental glucocerebrosidase by one amino acid at position 495, where histidine is substituted for arginine. The oligosaccharide chains at the glycosylation sites have been modified to terminate in mannose sugars. The modified carbohydrate structures on imiglucerase are somewhat different from those on placental glucocerebrosidase. These mannose-terminated oligosaccharide chains of imiglucerase are specifically recognized by endocytic carbohydrate receptors on macrophages, the cells that accumulate lipid in Gaucher disease.
Cerezyme® is supplied as a sterile, non-pyrogenic, white to off-white lyophilized product. The quantitative composition of the lyophilized drug is provided in the following table:
|Ingredient||200 Unit Vial||400 Unit Vial|
|Imiglucerase (total amount)*||212 units||424 units|
|Mannitol||170 mg||340 mg|
|Sodium Citrates||70 mg||140 mg|
|(Trisodium Citrate)||(52 mg)||(104 mg)|
|(Disodium Hydrogen Citrate)||(18 mg)||(36 mg)|
|Polysorbate 80, NF||0.53 mg||1.06 mg|
|Citric Acid and/or Sodium Hydroxide may have been added at the time of manufacture to adjust pH.|
|*This provides a respective withdrawal dose of 200 and 4 00 units of imiglucerase.|
An enzyme unit (U) is defined as the amount of enzyme that catalyzes the hydrolysis of 1 micromole of the synthetic substrate para-nitrophenyl-β-D-glucopyranoside (pNP-Glc) per minute at 37°C. The product is stored at 2-8°C (36-46°F). After reconstitution with Sterile Water for Injection, USP, the imiglucerase concentration is 40 U/mL (see DOSAGE AND ADMINISTRATION for final concentrations and volumes). Reconstituted solutions have a pH of approximately 6.1.
What are the possible side effects of imiglucerase (Cerezyme)?
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 imiglucerase. Approximately 15% of patients treated with imiglucerase 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.
Talk to your doctor if you experience any of the following less serious side...
What are the precautions when taking imiglucerase (Cerezyme)?
Before using imiglucerase, tell your doctor or pharmacist if you are allergic to it; or to alglucerase; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: antibodies to alglucerase.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known if this medication passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 8/2/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Cerezyme Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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