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Guidelines for CSF Administration

Assess the myelotoxic risk of the regimen

The American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) clinical practice guidelines recommend first- and subsequent-cycle colony-stimulating factors (CSFs) for myelosuppressive chemotherapy regimens with approximately ≥20% risk of febrile neutropenia.1,2

Identify additional risk factors based on the patient's medical history or previous treatment, which may increase the risk of febrile neutropenia

Treatment-related risk factors:

  • preexisting neutropenia or bone marrow involvement with tumor.2
  • prior myelosuppressive therapy.1
  • prior radiation therapy.2

Patient-related risk factors:

  • age >65 years.1,2
  • comorbid disease.1
  • advanced cancer.1
  • poor performance status.1,2
  • infection/open wounds.1,2
  • recent surgery.2
  • poor renal function.2
  • liver dysfunction, most notably elevated bilirubin.2

Consider first- and subsequent-cycle CSF support

“The 2005 Update Committee agreed unanimously that reduction in febrile neutropenia is an important clinical outcome that justifies the use of CSFs, regardless of impact on other factors, when the risk of febrile neutropenia is approximately 20% and no other equally effective regimen that does not require CSFs is available.”1 - Excerpted from 2006 ASCO guidelines.

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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. Smith T, Khatcheressian J, Lyman G, et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol. 2006;24:3187-3205.
  2. The NCCN Clinical Practice Guidelines in Oncology™ Myeloid Growth Factors (Version 1.2011). © 2011 National Comprehensive Cancer Network, Inc. Accessed April 28, 2011. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.
  3. Neulasta® (pegfilgrastim) prescribing information, Amgen.