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
Ontak Online, Description, Chemistry, Ingredients - Denileukin Diftitox
Ontak Online, Description, Chemistry, Ingredients - Denileukin Diftitox
DESCRIPTION
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WARNING: Only physicians experienced in the use of
antineoplastic therapy and management of patients with cancer should use
ONTAK (denileukin diftitox). Patients treated with denileukin diftitox
must be managed in a facility equipped and staffed for cardiopulmonary
resuscitation and where the patient can be closely monitored for an appropriate
period based on his or her health status.
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ONTAK™ (denileukin diftitox), a recombinant DNA-derived cytotoxic protein composed
of the amino acid sequences for diphtheria toxin fragments A and B (Met 1
-Thr 387 )-His followed by the sequences for interleukin-2
(IL-2; Ala 1 -Thr 133 ), is produced in an E. coli
expression system. ONTAK has a molecular weight of 58 kD. Neomycin is used
in the fermentation process but is undetectable in the final product. The product
is purified using reverse phase chromatography followed by a multistep diafiltration
process.
ONTAK is supplied in single use vials as a sterile, frozen solution intended
for intravenous (IV) administration. Each 2 mL vial of ONTAK contains 300 mcg
of recombinant denileukin diftitox in a sterile solution of citric acid (20
mM), EDTA (0.05 mM) and polysorbate 20 (<1%) in Water for Injection, USP.
The solution has a pH of 6.9 to 7.2.
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