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Pivotal Clinical Trial Data

Neulasta® phase 3 study design

Phase 3, multicenter, multinational, double-blind, placebo-controlled trial of patients with breast cancer receiving 100 mg/m2 docetaxel. Included 928 patients receiving placebo (n=465) or Neulasta® (n=463). Primary endpoint: percentage of patients who developed febrile neutropenia.1,2

94% reduction in febrile neutropenia (17% placebo vs 1% Neulasta®; P<0.001)1,2*

Neulasta®—used in every cycle—reduced risk across multiple endpoints1,2*:

  • 94% reduction in febrile neutropenia (17% placebo vs 1% Neulasta®; P<0.001)
  • 93% reduction in febrile neutropenia–related hospitalization (14% placebo vs 1% Neulasta®; P<0.001)
  • 80% reduction in febrile neutropenia–related IV anti-infective use (10% placebo vs 2% Neulasta®; P<0.001)1,2*
-Adapted from Vogel C, et al. J Clin Oncol. 2005; Neulasta® prescribing information.
  • *Febrile neutropenia = ANC <0.5 x 109/L and temperature ≥38.2° C.

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.

References

  1. Vogel C, Wojtukiewicz M, Carroll R, et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol. 2005;23:1178-1184.
  2. Neulasta® (pegfilgrastim) prescribing information, Amgen.