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 Online, Description, Chemistry, Ingredients - L-asparaginase
Oncaspar Online, Description, Chemistry, Ingredients - L-asparaginase
DESCRIPTION
ONCASPAR®, the ENZON trademark for pegaspargase, is a modified version
of the enzyme L-asparaginase. It is an oncolytic agent used in combination chemotherapy
for the treatment of patients with acute lymphoblastic leukemia who are hypersensitive
to native forms of L-asparaginase (as described in CLINICAL PHARMACOLOGY
).
The generic name for ONCASPAR® is pegaspargase. The chemical
name is monomethoxypolyethylene glycol succinimidyl L-asparaginase. L-asparaginase
is modified by covalently conjugating units of monomethoxypolyethylene glycol
(PEG), molecular weight of 5,000, to the enzyme, forming the active ingredient
PEG-L-asparaginase. The L-asparaginase (L-asparagine amidohydrolase, type EC-2,
EC 3.5.1.1) used in the manufacture of ONCASPAR® is derived from Escherichia
coli. ENZON purchases the enzyme L-asparaginase in bulk from Merck, Sharp
and Dohme, Division of Merck & Co., Inc., West Point, PA 19486, U.S. License
Number 2. Merck & Co., Inc. supplies bulk L-asparaginase as a licensed intermediate
for further manufacture by ENZON into PEG-L-asparaginase. Merck & Co., Inc.
can only assume responsibility for the bulk intermediate supplied to ENZON.
ONCASPAR® is supplied as an isotonic sterile solution in phosphate buffered
saline, pH 7.3, for intramuscular or intravenous administration only. The solution
is clear, colorless and contains no preservatives. It is supplied in 5 mL single-dose
vials.
ONCASPAR® activity is expressed in International Units (IU) according
to the recommendation of the International Union of Biochemistry. One IU of
L-asparaginase is defined as that amount of enzyme required to generate 1 µmol
of ammonia per minute at pH 7.3 and 37°C.
Each milliliter of ONCASPAR® contains:
PEG-L-asparaginase 750
IU ± 20%
Monobasic sodium phosphate, USP 1.20 mg ± 5%
Dibasic sodium phosphate, USP 5.58 mg ± 5%
Sodium chloride, USP 8.50 mg ± 5%
Water for injection, USP qs
to 1.0 mL
The specific activity of ONCASPAR® is at least 85 IU per milligram protein.
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