Leukocyte Growth Factor

Neutropenia

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-9"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Filgrastim is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology.  Filgrastim is produced by <span class="Italics">Escherichia coli (E coli)</span> bacteria into which has been inserted the human granulocyte colony-stimulating factor gene.  Filgrastim 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 <span class="Italics">E coli</span>.  Because filgrastim is produced in <span class="Italics">E coli</span>‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell.</p><p>NEUPOGEN injection is a sterile‚ clear‚ colorless‚ preservative-free liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 10<span class="Sup">8</span> U/mg (as measured by a cell mitogenesis assay).  The product is available in single-dose vials for subcutaneous or intravenous use and prefilled syringes for subcutaneous use.  The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim.  The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. The NEUPOGEN drug product has a pH of 4.0. See table below for product composition of each single-dose vial or prefilled syringe.</p><table width="85%"><col align="left" valign="top" width="20%"/><col align="center" valign="top" width="20%"/><col align="center" valign="top" width="20%"/><col align="center" valign="top" width="20%"/><col align="center" valign="top" width="20%"/><thead><tr class="First Last"><th align="left" class="Lrule"></th><th align="center">300 mcg/mL Vial</th><th align="center">480 mcg/1.6 mL Vial</th><th align="center">300 mcg/0.5 mL Syringe</th><th align="center" class="Rrule">480 mcg/0.8 mL Syringe</th></tr></thead><tfoot><tr><td align="left" colspan="5"><dl class="Footnote"><dt><a href="#footnote-reference-3" name="footnote-3">*</a></dt><dd>quantity sufficient to make.</dd></dl></td></tr></tfoot><tbody><tr class="First"><td align="left" class="Lrule">filgrastim</td><td align="center">300 mcg</td><td align="center">480 mcg</td><td align="center">300 mcg</td><td align="center" class="Rrule">480 mcg</td></tr><tr><td align="left" class="Lrule">acetate</td><td align="center">0.59 mg</td><td align="center">0.94 mg</td><td align="center">0.295 mg</td><td align="center" class="Rrule">0.472 mg</td></tr><tr><td align="left" class="Lrule">polysorbate 80</td><td align="center">0.04 mg</td><td align="center">0.064 mg</td><td align="center">0.02 mg</td><td align="center" class="Rrule">0.032 mg</td></tr><tr><td align="left" class="Lrule">sodium</td><td align="center">0.035 mg</td><td align="center">0.056 mg</td><td align="center">0.0175 mg</td><td align="center" class="Rrule">0.028 mg</td></tr><tr><td align="left" class="Lrule">sorbitol</td><td align="center">50 mg</td><td align="center">80 mg</td><td align="center">25 mg</td><td align="center" class="Rrule">40 mg</td></tr><tr><td align="left" class="Lrule">water for Injection</td><td align="center"></td><td align="center"></td><td align="center"></td><td align="center" class="Rrule"></td></tr><tr class="Last"><td align="left" class="Lrule">USP q.s. ad<a class="Sup" href="#footnote-3" name="footnote-reference-3">*</a></td><td align="center">1 mL</td><td align="center">1.6 mL</td><td align="center">0.5 mL</td><td align="center" class="Rrule">0.8 mL</td></tr></tbody></table></section>

NEUPOGEN

1 ML filgrastim 0.3 MG/ML Injection

1 ML filgrastim 0.3 MG/ML Injection [Neupogen]

1.6 ML filgrastim 0.3 MG/ML Injection

1.6 ML filgrastim 0.3 MG/ML Injection [Neupogen]

Neupogen

filgrastim

0.5 ML filgrastim 0.6 MG/ML Prefilled Syringe

0.5 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen]

0.8 ML filgrastim 0.6 MG/ML Prefilled Syringe

0.8 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen]

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Instructions For Use: Febrile Neutropenia

Instructions For Use: Acute Myeloid Leukemia (AML)

Instructions For Use: Peripheral Blood Progenitor Cell (PBPC)

Instructions For Use: Severe Chronic Neutropenia (SCN)

Instructions For Use: Bone Marrow Transplant (BMT)

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