You are now leaving NeulastaHCP.com

Please be aware that the sponsors of this site are not responsible for content on the site you are about to enter.

Return to Previous Page Continue to External Site

Neulasta® Data in NHL Patients

Neulasta® used every cycle resulted in a 94% reduction in febrile neutropenia.

  • Phase 3 study of patients with breast cancer (17% placebo vs 1% Neulasta®; P<0.001)1,2

Neulasta® reduced febrile neutropenia compared with reactive treatments in patients with non-Hodgkin's lymphoma (NHL) receiving CHOP ± R.

Community-based study design

Prospective, randomized, open-label, community-based study of patients with cancer who were ≥65 years of age and enrolled between June 2002 and November 2004 (N=852). Patients with solid tumors or NHL were randomized to the pegfilgrastim all-cycles arm (beginning cycle 1) or the physician-discretion arm (after cycle 1 in any cycle). In the physician-discretion arm, reactive treatments included no intervention, chemotherapy dose reduction or delay, or administration of pegfilgrastim. A post hoc subset analysis in non-Hodgkin's lymphoma patients (n=146) included 73 patients in each study arm. Most NHL patients (82%; n=120) received CHOP + R.3

-Adapted from Balducci L, et al. Oncologist. 2007.
  • *Reactive treatments included no intervention, chemotherapy dose reduction or delay, or administration of pegfilgrastim.

Neulasta® Helps Your Eligible Patients with Co-pays

Enroll your practice in the Neulasta FIRST STEP® Co-pay Coupon Program now.

Get Details »

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.
  3. Balducci L, Al-Halawani H, Charu V, et al. Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim. Oncologist. 2007;12:1416-1424.