Pegfilgrastim (Fulphila; Neulasta; Neulasta Onpro; Nyvepria; Udenyca;
Ziextenzo) J2506

Pegfilgrastim is a white blood cell growth factor with labeled use to decrease
the incidence of infection (as manifested by febrile neutropenia), in patients
with nonmyeloid malignancies receiving myelosuppressive cancer chemotherapy
associated with a clinically significant incidence of febrile neutropenia.1
The FDA label recommends administration starting 24 hours after the completion
of chemotherapy.

To improve compliance and convenience for patients by not having to return 24
hours after chemotherapy for administration there is an interest in same day
administration. A survey of physicians who administer pegfilgrastim reported
that 31.6% were treated on a "same-day" schedule utilizing patient related
considerations in the decision such as patient/caregiver travel distance and
practice related consideration such as burden on the practice for next day
administration as determining factors.2

A double blinded phase two non-inferiority study (n=266) concludes non-
inferiority of same day administration, but while not statistically
significant an increase in neutropenia within the same day administration
group as compared to next day administration group was reported. This lead to
the authors conclusion to recommendation for administration according to the
FDA label.3 Multiple retrospective studies support safety and efficacy of same
day administration, but also trending to non-statistically significant
increase in side effects with same day administration.4-6 A systematic review
including four randomized or single arm prospective studies and seven
retrospective studies support administration at least one day after
chemotherapy.7 NCCN guidelines state that pegfilgrastim same day administered
the day after myelosuppressive chemotherapy is supported by category one
evidence, however there is data for and against same day dosing and the FDA
approved dosing schedule is still recommended.8

Pegfiligrastim is recommended to be given according to FDA approved dosing
schedule. CGS will consider same day administration when patient/caregiver
circumstances create a significant barrier to compliance, such as lack of
transportation to return for dosing within recommended time frame. CGS expects
clear documentation for same day administration to be in the medical record
and available upon request.



References:

  1. Lexi-Drugs. Pegfilgrastim. [https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/7446?cesid=0knhsFEk1hS&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3DPegfilgastrim%26t%3Dname%26va%3DPegfilgastrim](https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/7446?cesid=0knhsFEk1hS&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3DPegfilgastrim%26t%3Dname%26va%3DPegfilgastrim). Accessed 5/1//2022.
  2. Marion S, Tzivelekis, S., Darden, C. et al. . "Same-Day" administration of pegfilgrastim following myelosuppressive chemotherapy: clinical practice and provider rationale. _Support Care Cancer_ 2016:3886-3896.
  3. Burris HA BC, Kaufman PA, et al. . Pegfilgrastim on the same day versus next day of chemotherapy in patients with breast cancer, non-small-cell lung cancer, ovarian cancer, and non-hodgkin's lymphoma: results of four multicenter, double-blind, randomized phase II studies. _J Oncol Pract._ 2010;6(2):133-140.
  4. Schuman SI LN, Robson K, et al. . Pegfilgrastim dosing on same day as myelosuppressive chemotherapy for ovarian or primary peritoneal cancer. . _J Support Oncol._ 2009;7(6):225-228.
  5. Whitworth JM MK, Shipman KA, Numnum TM, Kendrick JE, Kilgore LC, Straughn JM. . The safety and efficacy of day 1 versus day 2 administration of pegfilgrastim in patients receiving myelosuppressive chemotherapy for gynecologic malignancies. _Gynecol Oncol_ 2009;112:601-604.
  6. McBride A, Alrawashdh, N., Bartels, T., Moore, L., Persky, D., & Abraham. Same-day versus next-day pegfilgrastim or pegfilgrastim-cbqv in patients with lymphoma receiving CHOP-like chemotherapy. . _Future oncology (London, England)._ (2021;17(26):3485-3497.
  7. Lyman GH, Allcott, K., Garcia, J. et al. . The effectiveness and safety of same-day versus next-day administration of long-acting granulocyte colony-stimulating factors for the prophylaxis of chemotherapy-induced neutropenia: a systematic review. . _Support Care Cancer_ 2017;25:2619-2929.
  8. Oncology NCPGi. Hematopoietic Growth Factors Version 1.2022. <https://www.nccn.org/professionals/physician_gls/pdf/growthfactors.pdf>. Accessed 5/9/2022.