Drug Interaction:
No formal drug interaction studies between ERWINAZE and other drugs have been performed
Indication:
ERWINAZE (asparaginase Erwinia chrysanthemi)for injection, intramuscular use
Initial U.S. Approval: 2011
Drug Name- Erwinaze
Active Ingredient - Asparginase Erwina Chysanthemi
To treat acute lymphoblastic leukemia (ALL) who have developed an allergy
(hypersensitivity) to E.Coli derived asparaginase and pegapargase chemotherapy
drugs used to A.L.L
Indication-
Treat acute lymphoblastic leukemia (ALL) who have developed an allergy
(hypersensitivity) to E.Coli derived asparaginase and pegapargase chemotherapy
drugs used to A.L.L
Approved by FDA on 18-11--2011 (Ref- FDA approved List- 2011)
Adverse Reaction:
Most common adverse reactions (greater than >1%) are:
serious hypersensitivity reactions, including anaphylaxis, pancreatitis,
abnormal transaminases, coagulation abnormalities including thrombosis and
hemorrhage, nausea and vomiting, and hyperglycemia
Contra-Indications:
CONTRAINDICATIONS
History of serious hypersensitivity reactions to ERWINAZE, including anaphylaxis
History of serious pancreatitis with prior L-asparaginase therapy
History of serious thrombosis with prior L-asparaginase therapy
History of serious hemorrhagic events with prior L-asparaginase therapy
WARNINGS AND PRECAUTIONS
If the following occur, discontinue ERWINAZE:
Serious hypersensitivity reactions, including anaphylaxis
Severe or hemorrhagic pancreatitis
Glucose intolerance can occur and, in some cases, may be irreversible.
Perform appropriate monitoring and treat hyperglycemia with insulin, as necessary
Thrombosis, hemorrhage: discontinue ERWINAZE until resolved
Dosages/ Overdosage Etc:
Drug Name- Erwinaze
INDICATIONS AND USAGE
ERWINAZE (asparaginase Erwinia chrysanthemi) is an asparagine specific
enzyme 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.
DOSAGE AND ADMINISTRATION
To substitute for a dose of pegaspargase:
The recommended dose is 25,000 International Units/m2 administered intramuscularly
three times a week (Monday/Wednesday/Friday) for six doses for each planned
dose of pegaspargase.
To substitute for a dose of native E. coli asparaginase:
The recommended dose is 25,000 International Units/m2 administered intramuscularly
for each scheduled dose of native E. coli asparaginase.
Limit the volume of reconstituted ERWINAZE at a single injection site to 2 mL;
if reconstituted dose to be administered is greater than 2 mL, use multiple injection sites.
DOSAGE FORMS AND STRENGTHS
10,000 International Units lyophilized powder per vial.
Patient Information:
PATIENT COUNSELING INFORMATION
1.Instruct patients on the risk of allergic reactions, including anaphylaxis.
Describe the symptoms of allergic reactions, including anaphylaxis,
and instruct the patient to seek medical advice immediately if they experience
such symptoms.
2. Instruct patients on the risk of pancreatitis and to seek medical advice
immediately if they experience abdominal pain.
3. Instruct patients on the risk of hyperglycemia and glucose intolerance.
4.Advise patients to seek medical advice if they experience excessive thirst
or any increase in the volume or frequency of urination.
5. Instruct patients on the risk of thrombosis and hemorrhage and to seek
medical advice immediately if they experience headache, arm or leg swelling,
shortness of breath, and chest pain.
Pharmacology/ Pharmacokinetics:
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 the amino acid asparagine for their protein metabolism and survival.
2. Pharmacokinetics
The pharmacokinetics of ERWINAZE has not been characterized.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1.Pregnancy
Pregnancy category C.
There are no adequate and well-controlled studies of ERWINAZE in pregnant women.
Animal reproduction studies have not been conducted with ERWINAZE.
It is not known whether ERWINAZE can cause fetal harm when administered to a
pregnant woman or can affect reproduction capacity. ERWINAZE should be given
to a pregnant woman only if clearly needed.
2.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.
3..Geriatric Use
The safety and efficacy of ERWINAZE has not been studied in geriatric patients.
Manufacturer Details