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.