Cerezyme

DRUG DESCRIPTION

Cerezyme® (imiglucerase for injection) is an analogue of the human enzyme ?-glucocerebrosidase, produced by recombinant DNA technology. ?-Glucocerebrosidase (?-D-glucosyl-N-acylsphingosine glucohydrolase, E.C. 3.2.1.45) is a lysosomal glycoprotein enzyme which catalyzes the hydrolysis of the glycolipid glucocerebroside to glucose and ceramide.

Cerezyme® (imiglucerase) 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 N-linked 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 gluco-cerebrosidase. 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® (imiglucerase) 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 400 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-?-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...

Read All Potential Side Effects and See Pictures of Cerezyme »

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...

Read All Potential Precautions of Cerezyme »


Cerezyme Consumer (continued)

SIDE EFFECTS: Fever, headache, nausea, vomiting, swelling of the hands/feet (edema), or redness/pain/itching/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, flushing, chest pain, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 breast-feeding.


Cerezyme Patient Information Including Side Effects

Brand Names: Cerezyme

Generic Name: imiglucerase (Pronunciation: im ih GLUE ker ase)

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

What is imiglucerase (Cerezyme)?

Imiglucerase is a man-made form of the naturally-occurring protein beta-glucocerebrosidase. A deficiency of beta-glucocerebrosidase is called Gaucher disease.

Imiglucerase is used for the treatment of Type 1 Gaucher disease that results in one or more of the following: anemia (low level of red blood cells), thrombocytopenia (low level of platelets), bone disease, hepatomegaly (enlargement of the liver), or splenomegaly (enlargement of the spleen).

Imiglucerase may also be used for purposes other than those listed here.

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 effects:

  • discomfort, burning, itching, swelling, or abscess (open wound or sore) at the injection site;
  • nausea or vomiting;
  • abdominal pain;
  • diarrhea;
  • fatigue;
  • headache;
  • dizziness; or
  • rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about 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.

Related Drug Centers
  • Cerezyme


Related Drugs Index: