Pharmacokinetic data in geriatric patients ( ≥ 65 years) are not available.

Clinical Experience

Cancer Patients Receiving Myelosuppressive Chemotherapy

NEUPOGEN® has been shown to be safe and effective in accelerating the recovery of neutrophil counts following a variety of chemotherapy regimens. In a phase 3 clinical trial in small cell lung cancer‚ patients received SC administration of NEUPOGEN® (4 to 8 mcg/kg/day‚ days 4 to 17) or placebo. In this study‚ the benefits of NEUPOGEN® therapy were shown to be prevention of infection as manifested by febrile neutropenia‚ decreased hospitalization‚ and decreased IV antibiotic usage. No difference in survival or disease progression was demonstrated.

In the phase 3‚ randomized‚ double-blind‚ placebo-controlled trial conducted in patients with small cell lung cancer‚ patients were randomized to receive NEUPOGEN® (n = 99) or placebo (n = 111) starting on day 4‚ after receiving standard dose chemotherapy with cyclophosphamide‚ doxorubicin‚ and etoposide. A total of 210 patients were evaluated for efficacy and 207 evaluated for safety. Treatment with NEUPOGEN® resulted in a clinically and statistically significant reduction in the incidence of infection‚ as manifested by febrile neutropenia; the incidence of at least one infection over all cycles of chemotherapy was 76% (84/111) for placebo-treated patients‚ versus 40% (40/99) for NEUPOGEN®-treated patients (p < 0.001). The following secondary analyses were also performed. The requirements for in-patient hospitalization and antibiotic use were also significantly decreased during the first cycle of chemotherapy; incidence of hospitalization was 69% (77/111) for placebo-treated patients in cycle 1‚ versus 52% (51/99) for NEUPOGEN®-treated patients (p = 0.032). The incidence of IV antibiotic usage was 60% (67/111) for placebo-treated patients in cycle 1‚ versus 38% (38/99) for NEUPOGEN®- treated patients (p = 0.003). The incidence‚ severity‚ and duration of severe neutropenia (absolute neutrophil count [ANC] < 500/mm³) following chemotherapy were all significantly reduced. The incidence of severe neutropenia in cycle 1 was 84% (83/99) for patients receiving NEUPOGEN® versus 96% (106/110) for patients receiving placebo (p = 0.004). Over all cycles‚ patients randomized to NEUPOGEN® had a 57% (286/500 cycles) rate of severe neutropenia versus 77% (416/543 cycles) for patients randomized to placebo. The median duration of severe neutropenia in cycle 1 was reduced from 6 days (range 0 to 10 days) for patients receiving placebo to 2 days (range 0 to 9 days) for patients receiving NEUPOGEN® (p < 0.001). The mean duration of neutropenia in cycle 1 was 5.64 ± 2.27 days for patients receiving placebo versus 2.44 ± 1.90 days for patients receiving NEUPOGEN®. Over all cycles‚ the median duration of neutropenia was 3 days for patients randomized to placebo versus 1 day for patients randomized to NEUPOGEN®. The median severity of neutropenia (as measured by ANC nadir) was 72/mm³ (range 0/mm³ to 7912/mm³) in cycle 1 for patients receiving NEUPOGEN® versus 38/mm³ (range 0/mm³ to 9520/mm³) for patients receiving placebo (p = 0.012). The mean severity of neutropenia in cycle 1 was 496/mm³ ± 1382/mm³ for patients receiving NEUPOGEN® versus 204/mm³ ± 953/mm³ for patients receiving placebo. Over all cycles‚ the ANC nadir for patients randomized to NEUPOGEN® was 403/mm³‚ versus 161/mm³ for patients randomized to placebo. Administration of NEUPOGEN® resulted in an earlier ANC nadir following chemotherapy than was experienced by patients receiving placebo (day 10 vs day 12). NEUPOGEN® was well tolerated when given SC daily at doses of 4 to 8 mcg/kg for up to 14 consecutive days following each cycle of chemotherapy (see ADVERSE REACTIONS).

Several other phase 1/2 studies‚ which did not directly measure the incidence of infection‚ but which did measure increases in neutrophils‚ support the efficacy of NEUPOGEN®. The regimens are presented to provide some background on the clinical experience with NEUPOGEN®. No claim regarding the safety or efficacy of the chemotherapy regimens is made. The effects of NEUPOGEN® on tumor growth or on the anti-tumor activity of the chemotherapy were not assessed. The doses of NEUPOGEN® used in these studies are considerably greater than those found to be effective in the phase 3 study described above. Such phase 1/2 studies are summarized in the following table.

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