Amgen has announced that a prefilled syringe containing a more concentrated formulation of the white blood-cell booster, granulocyte colony stimulating factor (G-CSF, Neupogen) is now available to hospitals and health-care providers. Neupogen SingleJect, recently approved by the Food and Drug Administration (FDA), gives health-care providers the best opportunity to appropriately dose most patients and inject them with greater comfort. The premeasured syringe also eliminates the need for providers to handle multiple vials or syringes in order to deliver the appropriate dose.
Appropriate Dosing Made Easier
"We are pleased to provide physicians with Neupogen SingleJect to help ensure appropriate dosing of patients and to help make dosing easier," said Robin Campbell, vice-president of oncology, Amgen. "For patients, large subcutaneous injection volumes can be uncomfortable. The new concentrated formulation may help reduce a patient’s discomfort, and ultimately, their apprehension during what is already a difficult time."
Neupogen SingleJect will be available in two different syringe volumes: 300 mg in a volume of 0.5 mL or 480 mg in a volume of 0.8 mL. With the new concentrated formulation, the dose for Neupogen SingleJect is the same as G-CSF in vials5 mg/kg. However, the prefilled syringe saves time and is a much easier to administer. Now, a provider can give a patient weighing less than (or equal to) 132 lb either the original formula 1.0 mL vial (300 mg) or the 0.5 mL Neupogen SingleJect (300 mg), and a patient weighing more than 132 lb and up to 211 lb, the 1.6 mL vial (480 mg) or the 0.8 mL Neupogen SingleJect (480 mg). The two sizes of Neupogen SingleJect prefilled syringes will be packaged in individual syringe trays or boxes of 10 and will be specially color-coded to help caregivers distinguish the difference between the two strengths.
Risk of Infection Decreased
Based on the data submitted by Amgen, the FDA concluded that Neupogen SingleJect has the same clinical safety and efficacy as G-CSF in vials, and Neupogen SingleJect has the same indicationsincluding an indication to decrease the risk of infection associated with myelosuppressive therapies. Data have shown that, in the year 2001, as many as 500,000 newly diagnosed cancer patients will receive chemotherapy, and many of those will develop neutropenia.
"Neutropenia and resultant infections are a primary reason that patients have their chemotherapy doses reduced or delayed, and ongoing studies show these dose delays or reductions may negatively impact outcome," said Mr. Campbell. "Neupogen SingleJect will give health-care providers one more tool to help avoid serious infections and keep their patients out of the hospital and getting the greatest benefit they can out of their treatment."
Granulocyte colony-stimulating factor 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 significant incidence of severe neutropenia with fever. In the phase III trial of G-CSF therapy following combination chemotherapy in patients with small-cell lung cancer (N = 207), bone pain was reported in 22% of patients. In most cases, bone pain was controlled with nonnarcotic analgesics such as acetaminophen.