Rx Item-Erwinaze 10,000 IU 5Vials/Pack By Jazz Pharma

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1 INDICATIONS AND USAGE

ERWINAZE (asparaginase Erwinia chrysanthemi) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli -derived asparaginase.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose


To substitute for a dose of pegaspargase:

The recommended dose for each planned dose of pegaspargase is 25,000 International Units/m2 administered intramuscularly or intravenously three times a week (Monday/Wednesday/Friday) for six doses.

To substitute for a dose of native E. coli asparaginase:

The recommended dose is 25,000 International Units/m2 administered intramuscularly or intravenously for each scheduled dose of native E. coli asparaginase within a treatment.

When administering ERWINAZE intravenously, consider monitoring nadir (pre-dose) serum asparaginase activity (NSAA) levels and switching to intramuscular administration if desired NSAA levels are not achieved [see Clinical Pharmacology (12.3) ].

Erwinaze is an injectable medicine containing asparaginase Erwinia chrysanthemi. Asparaginase is a cancer medication that interferes with the growth and spread of cancer cells in the body.

3 DOSAGE FORMS AND STRENGTHS

Lyophilized powder 10,000 International Units per vial
11 DESCRIPTION

ERWINAZE (asparaginase Erwinia chrysanthemi) contains an asparagine specific enzyme derived from Erwinia chrysanthemi. L-asparaginase is a tetrameric enzyme consisting of four identical subunits, each having a molecular weight of about 35 kDa. The activity of ERWINAZE is expressed in terms of International Units.


ERWINAZE is supplied as a sterile, lyophilized, white powder in vials. Each vial contains 10,000 International Units of asparaginase Erwinia chrysanthemi , and the following inactive ingredients: glucose monohydrate (5.0 mg), sodium chloride (0.5 mg).
12.1 Mechanism of Action
Asparaginase Erwinia chrysanthemi catalyzes the deamidation of asparagine to aspartic acid and ammonia, resulting in a reduction in circulating levels of asparagine. The mechanism of action of ERWINAZE is thought to be based on the inability of leukemic cells to synthesize asparagine due to lack of asparagine synthetase activity, resulting in cytotoxicity specific for leukemic cells that depend on an exogenous source of amino acid asparagine for their protein metabolism and survival.

RX ITEM-Erwinaze 10,000 IU 5Vials/Pack B
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