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Erwinaze

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Erwinaze

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions

Grade 3 and 4 hypersensitivity reactions after the use of ERWINAZE have occurred in 5% of patients in clinical trials. Anaphylaxis after the use of ERWINAZE has occurred in 0.8% of patients in clinical trials [see ADVERSE REACTIONS].

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.

Pancreatitis

Pancreatitis has been reported with ERWINAZE therapy in 4% of patients in clinical trials [see ADVERSE REACTIONS].

Evaluate patients with symptoms compatible with pancreatitis to establish a diagnosis. Discontinue ERWINAZE for severe or hemorrhagic pancreatitis manifested by abdominal pain > 72 hours and amylase elevation ≥ 2.0 x ULN. Severe pancreatitis is a contraindication to additional asparaginase administration. In the case of mild pancreatitis, hold ERWINAZE until the signs and symptoms subside and amylase levels return to normal. After resolution, treatment with ERWINAZE may be resumed.

Glucose Intolerance

Glucose intolerance has been reported with ERWINAZE therapy in 4% of patients in clinical trials [see ADVERSE REACTIONS] and, in some cases, may be irreversible. Monitor glucose levels in patients at baseline and periodically during treatment. Administer insulin therapy as necessary in patients with hyperglycemia.

Thrombosis And Hemorrhage

Serious thrombotic events, including sagittal sinus thrombosis have been reported with both E. coli and Erwinia-derived Lasparaginase therapy. The following coagulation proteins were decreased in the majority of patients after a 2-week course of ERWINAZE: fibrinogen, protein C activity, protein S activity, and anti-thrombin III. Discontinue ERWINAZE for a thrombotic or hemorrhagic event until symptoms resolve; after resolution, treatment with ERWINAZE may be resumed.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No long-term carcinogenicity studies in animals have been performed with asparaginase Erwinia chrysanthemi. No studies that assess the mutagenic potential of asparaginase Erwinia chrysanthemi have been conducted.

In a fertility and early embryonic development study in rats, asparaginase Erwinia chrysanthemi had no effect on male or female fertility when administered intramuscularly at doses of up to 2000 IU/kg (approximately 50% of the recommended human dose, when adjusted for total body surface area) every other day for a total of 35 doses. Findings in males included decreased sperm count at doses of more than 500 IU/kg (approximately 12% of the recommended human dose).

Use In Specific Populations

Pregnancy

Pregnancy category C

Risk Summary

There are no adequate and well-controlled studies of ERWINAZE in pregnant women. In embryofetal development studies in rats and rabbits, asparaginase Erwinia chrysanthemi produced embryofetal toxicities and fetal abnormalities. ERWINAZE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Animal Data

In embryofetal development studies, asparaginase Erwinia chrysanthemi was administered intramuscularly every other day during the period of organogenesis to pregnant rats (at 500, 1000, or 2000 IU/kg) and rabbits (at 10, 25, and 40 IU/kg). In rats given 2000 IU/kg (approximately 50% of the recommended human dose, adjusted for body surface area), maternal toxicity of decreased body weight gain was observed, as well as a fetal finding of increased incidence of partially undescended thymic tissue.

In rabbits, maternal toxicity consisting of decreased body weight was observed at 40 IU/kg (approximately 2% of the recommended human dose, adjusted for body surface area). Increased post-implantation loss, a decrease in the number of live fetuses, and gross abnormalities (e.g., absent kidney, absent accessory lung lobe, additional subclavian artery, and delayed ossification) were observed at doses of ≥ 10 IU/kg (approximately 0.5% of the recommended human dose, adjusted for body surface area).

Nursing Mothers

It is not known whether ERWINAZE is secreted in human milk. Because many drugs are secreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ERWINAZE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

[See Clinical Studies].

Geriatric Use

The safety and efficacy of ERWINAZE has not been studied in geriatric patients.

Last reviewed on RxList: 3/21/2014
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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