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Clinical Study Details

Balducci L, et al. Oncologist. 2007;12:1416-1424.
  • Study design: Prospective, randomized, open-label, community-based study.
  • Patients: Non-Hodgkin's lymphoma (NHL) subset (n=146) of a larger study (N=852) in patients ≥65 years old receiving chemotherapy for all cancers.
  • Chemotherapy: 82% of patients (n=120) received R-CHOP.
  • G-CSF use: Patients were randomized to either Neulasta® (pegfilgrastim) in first and subsequent cycles (n=73) or no Neulasta® in cycle 1 with subsequent use at the physician's discretion (n=73).
  • Neutropenia-related endpoints: Overall incidence of febrile neutropenia (defined as ANC <1.0 x 109/L and temperature ≥38° C occurring on the same day), first-cycle incidence of febrile neutropenia, incidence of Grade 3 and Grade 4 neutropenia, neutropenia-related hospitalization, and antibiotic usage.
Link B, et al. Cancer. 2001;92:1354-1367.
  • Study design: Retrospective analysis of records from patients with early-stage breast cancer (ESBC) who were treated at 13 centers between 1993 and 1996.
  • Patients: Records from 1,111 patients with ESBC were analyzed.
  • Chemotherapy: Overall, CMF (38.9%) and AC (36.9%) were the most frequently used chemotherapy regimens.
  • Purpose: Describe recent practice in the use of chemotherapy, variations in the planned and delivered doses of chemotherapy, and the incidence of chemotherapy-induced complications in patients with ESBC.
Lyman G, et al. J Clin Oncol. 2003;21:4524-4531.
  • Study design: Retrospective, multicenter study of patients with early-stage breast cancer (ESBC).
  • Patients: Records from 20,799 patients with ESBC were analyzed.
  • Chemotherapy: The majority of patients (96%) received one of the following chemotherapy regimens: AC, CMF (21- or 28-day regimens), or CAF (21- or 28-day regimens).
  • Neutropenia-related endpoints: Relative dose intensity of chemotherapy delivered along with the incidence of chemotherapy relative dose intensity <85%, and incidence of chemotherapy dose delays ≥7 days or dose reductions ≥15%.
Lyman G, et al. J Clin Oncol. 2004;22:4302-4311.
  • Study design: Retrospective, multicenter study of patients with non-Hodgkin's lymphoma (NHL) treated between 1993 and 2001.
  • Patients: 4,522 patients with aggressive NHL.
  • Chemotherapy: 21-day CHOP, CHOP-R, or CNOP chemotherapy.
  • Neutropenia-related endpoints: Average relative dose intensity for each regimen, proportion of patients treated with relative dose intensity <85%, incidence of chemotherapy dose delays ≥7 days or dose reductions ≥15%, and febrile neutropenia.
Picozzi V, et al. Oncology. 2001;15:1296-1306.
  • Study design: Retrospective, multicenter assessment of patients with intermediate-grade non-Hodgkin's lymphoma (NHL).
  • Patients: Records from 653 patients with intermediate-grade NHL treated between 1991 and 1998 were analyzed.
  • Chemotherapy: The majority of patients (65%) received CHOP, 10% received CNOP, and 25% received other chemotherapy regimens.
  • Purpose: Describe recent practices in the use of chemotherapy, variations in the planned and delivered doses of chemotherapy, and the incidence of chemotherapy-induced complications in patients with NHL.
Vogel C, et al. J Clin Oncol. 2005;23:1178-1184.
  • Study design: Phase 3, multicenter, multinational, double-blind, placebo-controlled trial.
  • Patients: 928 patients with breast cancer.
  • Chemotherapy: Patients received docetaxel monotherapy.
  • G-CSF use: 465 patients received placebo treatment, while 463 received Neulasta® primary prophylaxis on day 2 of each 21-day chemotherapy cycle. Patients in the placebo group who experienced a neutropenic event were crossed over to open-label Neulasta®.
  • Neutropenia-related endpoint: Incidence of febrile neutropenia per patient (defined as ANC <0.5 x 109/L and temperature ≥38.2° C).
Weycker D, et al. Ann Oncol. 2008;19:454-460.
  • Study design: Retrospective matched cohort study of healthcare claims database from 2001 to 2003.
  • Patients: 746 cancer patients who received chemotherapy for breast cancer (38%), lung cancer (21%), non-Hodgkin's lymphoma (11%), and other cancers (30%) between July 1, 2001, and March 31, 2003.
  • Chemotherapy: Not reported.
  • G-CSF use: Not reported.
  • Neutropenia-related endpoint: Total healthcare costs related to neutropenic complications.

Indication

Neulasta® (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information

Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or Filgrastim.

Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta.

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta for ARDS. Discontinue Neulasta in patients with ARDS.

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta in patients with serious allergic reactions.

Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving Filgrastim, the parent compound of pegfilgrastim.

The granulocyte colony-stimulating factor (G-CSF) receptor, through which pegfilgrastim and Filgrastim act, has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.

Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients.

Please see the full prescribing information for Neulasta.