"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
Filgrastim is a human granulocyte colony-stimulating factor (G-CSF)‚ produced by recombinant DNA technology. NEUPOGEN® is the Amgen Inc. trademark for Filgrastim‚ which has been selected as the name for recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF).
NEUPOGEN® is a 175 amino acid protein manufactured by recombinant DNA technology.1 NEUPOGEN® is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. NEUPOGEN® has a molecular weight of 18‚800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli. Because NEUPOGEN® is produced in E coli‚ the product is nonglycosylated and thus differs from G-CSF isolated from a human cell.
NEUPOGEN® is a sterile‚ clear‚ colorless‚ preservative-free liquid for parenteral administration containing Filgrastim at a specific activity of 1.0 ± 0.6 x 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single use vials and prefilled syringes. The single use vials contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 1.0 mL or 1.6 mL, respectively. The single use prefilled syringes contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively. See table below for product composition of each single use vial or prefilled syringe.
|300 mcg/ 1.0 mL Vial||480 mcg/ 1.6 mL Vial||300 mcg/ 0.5 mL Syringe||480 mcg/ 0.8 mL Syringe|
|Filgrastim||300 mcg||480 mcg||300 mcg||480 mcg|
|Acetate||0.59 mg||0.94 mg||0.295 mg||0.472 mg|
|Sorbitol||50.0 mg||80.0 mg||25.0 mg||40.0 mg|
|Polysorbate 80||0.04 mg||0.064 mg||0.02 mg||0.032 mg|
|Sodium||0.035 mg||0.056 mg||0.0175 mg||0.028 mg|
|Water for Injection USP q.s. ad||1.0 mL||1.6 mL||0.5 mL||0.8 mL|
1. Zsebo KM‚ Cohen AM‚ Murdock DC‚ et al. Recombinant human granulocyte colonystimulating factor: Molecular and biological characterization. Immunobiol. 1986;172:175-184.
What are the possible side effects of filgrastim (Neupogen, Neupogen SingleJect)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using filgrastim and call your doctor at once if you have a serious side effect such as:
- sudden or severe pain in your left upper stomach spreading up to your shoulder;
- rapid breathing or feeling short of breath; or
- signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and...
What are the precautions when taking filgrastim (Neupogen)?
Before using filgrastim, tell your doctor or pharmacist if you are allergic to it; or to tbo-filgrastim/pegfilgrastim; or to other medications made in a similar manner (biotechnology-produced proteins using E. coli); or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: sickle cell disease, heart disease, spleen problems, other blood disorders (e.g., myelodysplastic syndrome, congenital neutropenia), certain skin disorders (e.g., psoriasis).
If you are scheduled to have...
Last reviewed on RxList: 6/4/2012
This monograph has been modified to include the generic and brand name in many instances.
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