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Asparaginase

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Overview

What is ERWINAZE?

ERWINAZE (asparaginase) contains an asparagine specific enzyme derived from . 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.

Erwinia chrysanthemi



What does ERWINAZE look like?



What are the available doses of ERWINAZE?

• 10,000 International Units lyophilized powder per vial.

What should I talk to my health care provider before I take ERWINAZE?

How should I use ERWINAZE?

ERWINAZE (asparaginase ) 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 -derived asparaginase.

To substitute for a dose of pegaspargase:

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

To substitute for a dose of native asparaginase:

The recommended dose is 25,000 International Units/m administered intramuscularly or intravenously for each scheduled dose of native 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 [].


What interacts with ERWINAZE?

Sorry No Records found


What are the warnings of ERWINAZE?

Sorry No Records found


What are the precautions of ERWINAZE?

Sorry No Records found


What are the side effects of ERWINAZE?

Sorry No records found


What should I look out for while using ERWINAZE?

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What might happen if I take too much ERWINAZE?

There are no known cases of overdose with ERWINAZE.


How should I store and handle ERWINAZE?

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Repackaged By:Cardinal HealthZanesville, OH 43701L49929540815Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Repackaged By:Cardinal HealthZanesville, OH 43701L49929540815Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Repackaged By:Cardinal HealthZanesville, OH 43701L49929540815Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Repackaged By:Cardinal HealthZanesville, OH 43701L49929540815Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Repackaged By:Cardinal HealthZanesville, OH 43701L49929540815Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Repackaged By:Cardinal HealthZanesville, OH 43701L49929540815ERWINAZE is a sterile, white lyophilized powder supplied in a clear 3 mL glass vial. Each carton of ERWINAZE (NDC 57902-249-05) contains 5 vials. Each single vial (NDC 57902-249-01) contains 10,000 International Units asparaginase .Store unused or unopened vials and cartons at 36°F to 46°F (2°C to 8°C). Protect from light. Do not use ERWINAZE after the expiration date on the vial.ERWINAZE is a sterile, white lyophilized powder supplied in a clear 3 mL glass vial. Each carton of ERWINAZE (NDC 57902-249-05) contains 5 vials. Each single vial (NDC 57902-249-01) contains 10,000 International Units asparaginase .Store unused or unopened vials and cartons at 36°F to 46°F (2°C to 8°C). Protect from light. Do not use ERWINAZE after the expiration date on the vial.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Asparaginase 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.

Non-Clinical Toxicology
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Grade 3 and 4 hypersensitivity reactions after the use of ERWINAZE have occurred in 5% of patients in clinical trials [].

Administer this product in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. If a serious hypersensitivity reaction occurs, discontinue ERWINAZE and initiate appropriate therapy.

The following serious adverse reactions are discussed in greater detail in other sections of the label:

The most common adverse reactions (incidence 1% or greater) with ERWINAZE treatment are systemic hypersensitivity, hyperglycemia, transaminases abnormal, fever, pancreatitis, local reactions, vomiting, nausea, thrombosis, hyperbilirubinemia, abdominal pain/discomfort, and diarrhea.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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