A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Oncaspar Indications, Dosage, Storage, Stability - L-asparaginase
Oncaspar Indications, Dosage, Storage, Stability - L-asparaginase
INDICATIONS
AND USES
ONCASPAR® is indicated for patients with acute lymphoblastic leukemia
who require L-asparaginase in their treatment regimen, but have developed hypersensitivity
to the native forms of L-asparaginase (SEE CLINICAL PHARMACOLOGY). ONCASPAR®,
like native L-asparaginase, is generally used in combination with other
chemotherapeutic agents, such as vincristine, methotrexate, cytarabine, daunorubicin,
and doxorubicin. 1,5 Use of ONCASPAR® as a single agent should
only be undertaken when multi-agent chemotherapy is judged to be inappropriate
for the patient.
DOSAGE AND ADMINISTRATION
As a component of selected multiple agent regimens, the recommended dose of
ONCASPAR® is 2,500 IU/m 2 every 14 days by either the intramuscular
or intravenous route of administration.
The preferred route of administration, however, is the intramuscular route
because of the lower incidence of hepatotoxicity, coagulopathy, and gastrointestinal
and renal disorders compared to the intravenous route of administration.
The safety and effectiveness of ONCASPAR® have been established in patients
with known previous hypersensitivity to L-asparaginase whose ages ranged from
1 to 21 years old. The recommended dose of ONCASPAR® for children with
a body surface area ≥0.6 m 2 is 2,500 IU/m 2 administered
every 14 days. The recommended dose of ONCASPAR® for children with a
body surface area <0.6 m 2 is 82.5 IU/kg administered every 14
days.
Do not administer ONCASPAR® if there is any indication that the drug
has been frozen. Although there may not be an apparent change in the appearance
of the drug, ONCASPAR®'s activity is destroyed after freezing.
When administering ONCASPAR® intramuscularly, the volume at a single
injection site should be limited to 2 mL. If the volume to be administered is
greater than 2 mL, multiple injection sites should be used.
When administered intravenously, ONCASPAR® should be given over a period
of 1 to 2 hours in 100 mL of sodium chloride or dextrose injection 5%, through
an infusion that is already running.
Anaphylactic reactions require the immediate use of antihistamines, epinephrine,
oxygen, and intravenous steroids.
Use of ONCASPAR® as the sole induction agent should be undertaken only
in an unusual situation when a combined regimen, which uses other chemotherapeutic
agents such as vincristine, methotrexate, cytarabine, daunorubicin, or doxorubicin,
is inappropriate because of toxicity or other specific patient-related factors,
or in patients refractory to other therapy. When ONCASPAR® is to be used
as the sole induction agent, the recommended dosage regimen is also 2,500 IU/m
2 every 14 days.
When a remission is obtained, appropriate maintenance therapy may be instituted.
ONCASPAR® may be used as part of a maintenance regimen.
Parenteral drug products should be inspected visually for particulate matter,
cloudiness or discoloration prior to administration, whenever solution and container
permit.
HOW SUPPLIED
Dosage Form
ONCASPAR®: Use only one dose per vial; do not re-enter the
vial. Discard unused portions. Do not save unused drug for later administration.
Sterile solution for injection in ready to use single-use vials. Preservative
free.
Quantity per Individual Container
5 mL per vial containing 750 IU/mL ONCASPAR® in a clear, colorless,
phosphate buffered saline solution, pH 7.3. Each vial contains 3,750 IU of ONCASPAR®.
Handling and Storage
Avoid excessive agitation. DO NOT SHAKE.
Keep refrigerated at +2°C to +8°C (36°F to 46°F).
Do not use if cloudy or if precipitate is present.
Do not use if stored at room temperature for more than 48 hours.
DO NOT FREEZE. Do not use product if it is known to have been frozen. Freezing
destroys activity, which cannot be detected visually.
NDC 0075-0640-05
REFERENCES
- Capizzi, RL and Holcenberg, JS. Asparaginase. In: Holland and Frei (eds).
Cancer Med third edition, Lea and Febiger, Phila. PA, 1993.
- Ho, DH, et al. Clinical pharmacology of polyethylene glycol-L-asparaginase.
Drug Metab Dispos 14 (3): 349-352, 1986.
- Asselin, BL, et al. Comparative Pharmacokinetic Studies of Three L-asparaginase
Preparations. J Clin Oncology (11): 1780-1786, 1993.
- Data on File at ENZON.
- Clavell, LA, et al. Four-agent induction and intensive asparaginase therapy
for treatment of childhood acute lymphoblastic leukemia. N Engl J Med 315
(11): 657-663, 1986.
Manufactured by:
Enzon, Inc.
40 Kingsbridge Road
Piscataway, NJ 08854-3998 USA
Distributed by: Aventis Pharmaceuticals Products Inc.
Parsippany, NJ 07054
All rights reserved
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