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
Roferon-A Online, Description, Chemistry, Ingredients - Peginterferon alfa-2b
Roferon-A Online, Description, Chemistry, Ingredients - Peginterferon alfa-2b
DESCRIPTION
WARNING
Alpha interferons, including PEG-Intron, cause or aggravate fatal or life-threatening
neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients
should be monitored closely with periodic clinical and laboratory evaluations.
Patients with persistently severe or worsening signs or symptoms of these
conditions should be withdrawn from therapy. In many but not all cases these
disorders resolve after stopping PEG-Intron therapy. See WARNINGS , ADVERSE
REACTIONS. |
PEG-Intron™, peginterferon alfa-2b Powder for Injection, is a covalent conjugate
of recombinant alfa interferon with monomethoxy polyethylene glycol (PEG). The
molecular weight of the PEG portion of the molecule is 12,000 daltons. The average
molecular weight of the PEG-Intron molecule is approximately 31,000 daltons.
The specific activity of pegylated interferon alfa-2b is approximately 0.7 ×
10 8 IU/mg protein.
Interferon alfa-2b, the starting material used to manufacture PEG-Intron, is
a water-soluble protein with a molecular weight of 19,271 daltons produced by
recombinant DNA techniques. It is obtained from the bacterial fermentation of
a strain of Escherichia coli bearing a genetically engineered plasmid
containing an interferon gene from human leukocytes.
PEG-Intron is a white to off-white lyophilized powder supplied in 2-mL vials
for subcutaneous use. Each vial contains either 74 µg, 118.4 µg, 177.6 µg, or
222 µg of PEG-Intron, and 1.11 mg dibasic sodium phosphate anhydrous, 1.11 mg
monobasic sodium phosphate dihydrate, 59.2 mg sucrose and 0.074 mg polysorbate
80. Following reconstitution with 0.7 mL of the supplied diluent (Sterile Water
for Injection, USP), each vial contains PEG-Intron at strengths of either 100
µg/mL, 160 µg/mL, 240 µg/mL or 300 µg/mL.
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