Neulasta® is a recombinant (genetically engineered) protein that stimulates the production of infection-fighting white blood cells called neutrophils that are depleted by cytotoxic chemotherapy, a condition called neutropenia. Neulasta® is a longer-acting form of NEUPOGEN® (Filgrastim), Amgen’s original white blood cell stimulating product. Neulasta® requires only one injection per chemotherapy cycle, while NEUPOGEN® may require daily injections for up to 14 days following chemotherapy.
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Neulasta® Indication and Important Product Safety Information for Physicians
Neulasta® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Important Product Safety Information
Splenic rupture (including fatal cases), acute respiratory distress syndrome, and sickle cell crises have been reported. Allergic reactions, including anaphylaxis, have also been reported. The majority of these reactions occurred upon initial exposure. However, in rare cases, allergic reactions, including anaphylaxis, recurred within days after discontinuing anti-allergic treatment.
In a placebo-controlled trial, bone pain occurred at a higher incidence in Neulasta®-treated patients as compared to placebo-treated patients (31% vs 26%). The most common adverse events reported in either placebo- or active-controlled trials were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain.
