Prefilled Syringe May Make Injections More Comfortable

April 1, 2001

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

Amgen has announced that a prefilled syringe containing a moreconcentrated formulation of the white blood-cell booster, granulocyte colonystimulating factor (G-CSF, Neupogen) is now available to hospitals andhealth-care providers. Neupogen SingleJect, recently approved by the Food andDrug Administration (FDA), gives health-care providers the best opportunity toappropriately dose most patients and inject them with greater comfort. Thepremeasured syringe also eliminates the need for providers to handle multiplevials or syringes in order to deliver the appropriate dose.

Appropriate Dosing Made Easier

"We are pleased to provide physicians with NeupogenSingleJect to help ensure appropriate dosing of patients and to help make dosingeasier," said Robin Campbell, vice-president of oncology, Amgen. "Forpatients, large subcutaneous injection volumes can be uncomfortable. The newconcentrated formulation may help reduce a patient’s discomfort, andultimately, their apprehension during what is already a difficult time."

Neupogen SingleJect will be available in two different syringevolumes: 300 mg in a volume of 0.5 mL or 480 mg in a volume of 0.8 mL. Withthe new concentrated formulation, the dose for Neupogen SingleJect is the sameas G-CSF in vials—5 mg/kg. However, the prefilled syringe saves time and is amuch 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 0.5mL Neupogen SingleJect (300 mg), and a patient weighing more than 132 lb and upto 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 inindividual syringe trays or boxes of 10 and will be specially color-coded tohelp caregivers distinguish the difference between the two strengths.

Risk of Infection Decreased

Based on the data submitted by Amgen, the FDA concluded thatNeupogen SingleJect has the same clinical safety and efficacy as G-CSF in vials,and Neupogen SingleJect has the same indications—including an indication todecrease the risk of infection associated with myelosuppressive therapies. Datahave shown that, in the year 2001, as many as 500,000 newly diagnosed cancerpatients will receive chemotherapy, and many of those will develop neutropenia.

"Neutropenia and resultant infections are a primary reasonthat patients have their chemotherapy doses reduced or delayed, and ongoingstudies show these dose delays or reductions may negatively impactoutcome," said Mr. Campbell. "Neupogen SingleJect will givehealth-care providers one more tool to help avoid serious infections and keeptheir patients out of the hospital and getting the greatest benefit they can outof their treatment."

Granulocyte colony-stimulating factor is indicated to decreasethe incidence of infection, as manifested by febrile neutropenia, in patientswith nonmyeloid malignancies receiving myelosuppressive anticancer drugsassociated with a significant incidence of severe neutropenia with fever. In thephase III trial of G-CSF therapy following combination chemotherapy in patientswith small-cell lung cancer (N = 207), bone pain was reported in 22% ofpatients. In most cases, bone pain was controlled with nonnarcotic analgesicssuch as acetaminophen.