Cerezym

Cerezyme Imiglucerase Genzyme Treatment of Gaucher s disease... 

Additional Aldurazyme, Amevive, Cerezyme, Enbrel, Fabrazyme, Inductos, Infuse, Osigraft/OP-1 implant, Pulmozyme, Regranex, Replagal... 

Cerezyme is produced in a CHO cell line harbouring the cDNA coding for human (i-glucoccr-ebrosidase. The purified product is presented as a freeze-dried powder, which also contains mannitol, sodium citrate, citric acid and polysorbate 80 as excipients. It exhibits a shelf life of 2 years when stored at 2-8 °C. 

Enzyme replacement Gaucher s disease, Fabry disease, and mucopolysaccharidosis Cerezyme, Fabrazyme, Aldurazyme... 

A), 3.8 billion Amgen s white blood cell stimulant, Neupogen (filgrastim), 3.0 billion interferon pia (Avonex for multiple sclerosis), 2.2 billion human growth hormone (HGH), 1.8 billion recombinant hepatitis B vaccine ( 1.0 billion) somatropin (Humatrope and Neutropin), 0.9 billion and cerezyme/ceredase (alglucerase), 0.6 billion. 

Cerezyme glucocere- broxidase Gaucher disease CHO 1994 USA, Austria, New Zealand... 

Some of the previously unavailable enzymes for therapeutic use include domase (Pulmozyme), imiglucerase (Cerezyme), asparaginase, tissue-type plasminogen activator (Activase), and related drugs (Retavase). Detailed information about these products and their clinical use is provided in Part II in the form of monographs. Information relevant to pharmacokinetics and molecular characteristics can be found in Appendixes I and II. 

Enzyme replacement is a chronic therapy that typically requires administration every week or two. Antibody response is a concern because immune reactions could produce signihcant morbidity, and mortality in rare cases. According to the manufacturer, about 15% of patients treated to date have developed IgG antibodies to Cerezyme within the hrst year, and most often within six months of initiating therapy. After 12 months of therapy, patients who do not seroconvert are less likely to develop antibodies. Nearly half of patients with detectable IgG antibodies are reported to experience some symptoms of hypersensitivity. Whether exposure of mannose on the enzyme (for targeting the enzyme to leukocytes) plays a role in eliciting or enhancing antibody response to the enzyme is not known and probably worth investigating. About 13% of patients on Ceredase also produce antibody response to the enzyme extracted from placenta. 

Type of submission Product license application (Ceredase), Biologic license application (Cerezyme)... 

B. Indications and nse Ceredase and Cerezyme are indicated for long-term replacement therapy in type 1 Gaucher s disease, which results in one or more of the following conditions anemia, thrombocytopenia, bone disease, and hepatomegaly or splenomegaly. 

Dosage form Ceredase is a sterile solution for injection, supplied in 5ml bottles containing alglucerase 80 units/ml. Cerezyme is supplied as a sterile lyophilized product for injection. Each vial contains imiglucerase 212 or 424 units. Amost all patients with Gaucher s disease use Cerezyme for enzyme replacement therapy. Ceredase is only available in limited supplies for the treatment of patients who do not tolerate Cerezyme. 

Route of administration Ceredase, on dilution, is administered as an intravenous infusion. Cerezyme, after reconstitution with sterile water for injection, is also administered as an intravenous infusion. 

Recommended dosage and monitoring requirements The initial dose of alglucerase is 60 units/kg, infused intravenously over 1 to 2 hours. This dose is usually repeated every 2 weeks, but may be given as often as every other day or as infrequently as every 4 weeks depending on response. The initial dose of Cerezyme is 2.5 to 60 units/kg infused intravenously over 1 to 2 hours. This dose is usually repeated every 2 weeks, but may be given as often as three times a week or as infrequently as every 4 weeks depending on clinical response. 

Drug interactions Caution may be advisable in administration of Cerezyme to patients previously treated with Ceredase and who have developed antibodies to Ceredase or who have exhibited symptoms of hypersensitivity to Ceredase. 

E. Therapeutic response Significant reductions in hepatosplenomegaly, improvement in hematologic deficiencies, and decreased cachexia have been reported with long-term Cerezyme therapy in patients with type 1 Gaucher s disease. Symptomatic improvement occurs within 6 months of induction of therapy. Serum hemoglobin and platelet values decrease to near-baseline values within 6 months of discontinuation of therapy. 

F. Role in therapy Ceredase and Cerezyme are important advances in the treatment of type 1 Gaucher s disease. 

G. Other considerations Ceredase and Cerezyme have been designated as orphan products for use in the treatment of types 1,2, and 3 Gaucher s disease. 

Genzyme s Ceredase /Cerezyme (alglucerase/recombinant alglucerase) approved for type 1 Gaucher s disease. 

Genzyme Ceredase (alglucerase) Cerezyme (imiglucerase) Gaucher disease Expired Expired... 

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