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Subject:       pegfilgrastim injection (Neulasta®)

Date reviewed:         12/9/2009

Description
Like filgrastim (Neupogen), pegfilgrastim is a human granulocyte colony stimulating factor (G-
CSF) which acts on hematopoietic cells and has various functions such as stimulating the
production of neutrophils within the bone marrow. Pegfilgrastim has a longer duration of action
than filgrastim and is given once per chemotherapy cycle. Pegfilgrastim is Food and Drug
Administration (FDA) approved for the following indication:
        Cancer patients receiving myelosuppressive chemotherapy.

Pegfilgrastim is supplied as a preservative-free solution containing 6 mg in 0.6 mL in a prefilled
single dose syringe for subcutaneous (SC) injection.1 The needle cover of the prefilled syringe
contains dry natural rubber (a derivative of latex).


Indications, Medically Necessary

    1. Cancer patients receiving myelosuppressive chemotherapy: Indicated in cancer
    patients (adults and children) receiving myelosuppressive chemotherapy who meet all of the
    following criteria.

   Pegfilgrastim is prescribed by an oncologist or hematologist, and

   Patient has a nonmyeloid malignancy, and

   Patient is receiving myelosuppressive anti-cancer drugs that are associated with a significant
    incidence of severe neutropenia with fever, that is, the risk of febrile neutropenia is at least
    20% based on the chemotherapy regimen. Note: Myelosuppressive chemotherapy regimens
    associated with a significant incidence of severe neutropenia are listed in the NCCN
    guidelines2 and in the ASCO guidelines.3 These references may not be a complete list, as
    new regimens are being developed.
        OR
    Patient is receiving myelosuppressive anti-cancer drugs that are associated with a significant
    incidence of severe neutropenia with fever but the risk is less than 20% based on the
    chemotherapy regimen if the patient has one or more risk factors for febrile neutropenia
    which includes the following:
         Older patient, especially aged ≥ 65 years
         History of previous chemotherapy or radiation therapy
         Pre-existing neutropenia
         Bone marrow involvement with tumor
         Open wounds or active infection
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        Recent surgery
        Poor performance status
        Poor renal function
        Liver dysfunction, most notably elevated bilirubin
        Previous episodes of febrile neutropenia
        Poor nutritional status
        Other serious comorbidities as determined by the physician
       OR
   Patient has had a neutropenic complication from prior chemotherapy and did not receive
   prophylaxis with a CSF and a reduced dose may compromise treatment outcome. This is
   secondary prophylaxis.

   Note: Patients who present with febrile neutropenia and have received prophylactic
   pegfilgrastim during the current chemotherapy cycle should not receive additional CSF.2
   Patients who present with febrile neutropenia and did not receive prophylactic CSF and who
   have risk factors for an infection-associated complication should be considered for CSF,
   either filgrastim or sargramostim, but not pegfilgrastim.

   Dosing in cancer patients receiving myelosuppressive chemotherapy: The recommended
   dosage of pegfilgrastim in adults and adolescents who weigh ≥ 45 kg is a single SC injection
   of 6 mg administered once per chemotherapy cycle.1 Pegfilgrastim should not be
   administered in the period between 14 days before and 24 hours after administration of
   cytotoxic chemotherapy. Not recommended for chemotherapy schedules less than 2 weeks.
   Weekly dosing is not recommended. The 6 mg fixed-dose formulation should not be used in
   infants, children, and smaller adolescents weighing less than 45 kg. For infants, children,
   and smaller adolescents weighing < 45 kg, a single 100 mcg/kg dose is given once per
   chemotherapy cycle; maximum dose is 6 mg.1,7-12 No dosing adjustment is necessary for
   renal dysfunction.

   Initial approval/extended approval in cancer patients receiving myelosuppressive
   chemotherapy: Initial approval is for one dose per each chemotherapy cycle. Multiple
   doses in the same cycle are not recommended.

   Duration of therapy in cancer patients receiving myelosuppressive chemotherapy:
   therapy may continue as long as the patient is receiving myelosuppressive chemotherapy
   with one dose per cycle.

   Labs/Diagnostics required: A complete blood count (CBC) and platelet count should be
   obtained before chemotherapy is administered. Regular monitoring of hematocrit value and
   platelet count is recommended.1

   Waste management: Pegfilgrastim is available as a 6 mg prefilled syringe. The dose in
   adults and adolescents weighing ≥ 45 kg is 6 mg SC given once per chemotherapy cycle. It
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    should not be given if chemotherapy regimens that given less than every 14 days. That is, if
    chemotherapy is given on day 1 and day 15 schedule, then pegfilgrastim could be used. For
    infants, children, and smaller adolescents weighing < 45 kg, a single 100 mcg/kg dose is used
    once      per      chemotherapy       cycle.        Maximum         dose     is    6      mg.
    http://www.neulasta.com/pdf/Neulasta_PI.pdf

    Exclusions: cancer patients receiving myelosuppressive chemotherapy. See more below.
        Prophylactic use in patients on concurrent chemotherapy and radiation therapy.1
        Use before or concurrently with chemotherapy.
        Patients not meeting the criteria for cancer patients receiving myelosuppressive
           therapy as defined above.
        Febrile neutropenia in patients who have received prophylactic pegfilgrastim during
           the current chemotherapy cycle should not receive additional pegfilgrastim or other
           colony stimulating factors (CSF).2
        Use in patients receiving concomitant chemotherapy and radiation therapy.


    2. Radiation injury: Indicated in patients (adults and children) with acute intentional or
    accidental radiation injury who meet all of the following criteria.4-5       [NOT FDA-
    APPROVED INDICATION]

   Pegfilgrastim is prescribed by a physician with experience in treating acute radiation
    syndrome, and

   The estimated whole body or significant partial-body exposure is at least 3 Grays in adults
    aged < 60 years; OR at least 2 Grays in children (aged < 12 years) and in adults aged ≥ 60
    years OR in those who have major trauma injuries or burns.4-5

    Dosing in radiation injury: For adults, administer one pegfilgrastim SC dose of 6 mg. For
    adolescents > 45 kg, administer one pegfilgrastim SC dose of 6 mg.4-5

    Initial/approval/extended approval in radiation injury:        An initial one time dose is
    recommended.

    Duration of therapy in radiation injury: Pegfilgrastim may need to be reinstituted if
    significant neutropenia occurs after discontinuation (absolute neutrophil count [ANC]
    is < 500/mm3 or < 0.5 x 109 cells/L).4 In general, therapy may be withdrawn when the ANC
    reaches a level of greater than 1000/mm3 or 1.0 x 109 cells/L.

    Labs/Diagnostics required: Monitor CBC and ANC as needed to follow guidelines for
    pegfilgrastim use.



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pegfilgrastim injection (Neulasta®)


     Waste management: Pegfilgrastim is available as a 6 mg syringe. This dose should be
     sufficient. http://www.neulasta.com/pdf/Neulasta_PI.pdf


     Exclusions: radiation injury. See more below.
         In children and adults ≥ 60 years or in those have had major trauma, injuries or burns,
            the radiation dose is less than 2 Grays.4-5
         In adults aged < 60 years, the radiation dose is less than 3 Grays.4-5


     Exclusions for all:
         Hypersensitivity to filgrastim.
         Peripheral blood progenitor cell (PBPC) mobilization or use after PBPC
            transplantation.1
         Patients with afebrile neutropenia.3
         Febrile neutropenia in patients who did not receive prophylactic CSF (pegfilgrastim,
            filgrastim, or sargramostim) and who have risk factors for an infection-associated
            complication should be considered for therapy with either filgrastim or sargramostim,
            but not pegfilgrastim.2
         Myelodysplastic syndrome (MDS).6 The efficacy has not been established and it is
            not recommended in the most recent NCCN guidelines for MDS.
         Drug-induced neutropenia.


ABBREVIATIONS
ANC = absolute neutrophil count
ASCO = American Society of Clinical Oncology
CBC = complete blood count
CSF = colony stimulating factor
FDA = Food and Drug Administration
MDS = myelodysplastic syndrome
IV = intravenous
mL = milliliter
NCCN = National Comprehensive Cancer Network
PBPC = peripheral blood progenitor cell
SC = subcutaneous


REFERENCES
1.   Neulasta® [package insert]. Thousand Oaks, CA: Amgen, Inc.; November 2008.
2.   NCCN Clinical Practice Guidelines in Oncology™.                  Myeloid growth factors.      V.I.2010. Available at:
     http://www.nccn.org/professionals/physician_gls/f_guidelines.asp Accessed 9/3/2009.
3.   Smith TJ, Khatcheressian J, Lyman GH, 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;2006;24:3187-3205.

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pegfilgrastim injection (Neulasta®)


4.  Radiation Injury Transplant Network. Acute Radiation Syndrome Treatment Guidelines. November 16, 2006. Accessed
    November 16, 2009 at http://www.nmdp.org/RITN/GUIDELINES/DOCS/ars_treatment_guidel.pdf
5. Waselenko JK, MacVittie TJ, Blakely WF, et al. Medical management of acute radiation syndrome: recommendations of
    the strategic national stockpile radiation working group. Ann Intern Med. 2004;140:1037-1051.
6. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Myelodysplastic syndromes.
    V.2.2010.
7. Wendelin G, Lackner H, Schwinger W, et al. Once-per-cycle pegfilgrastim versus daily filgrastim in pediatric patients with
    Ewing sarcoma. J Pediatr Hematol Oncol. 2005;27(8):449-451.
8. te Poele EM, Kamps WA, Tamminga RYJ, et al. Pegfilgrastim in pediatric cancer patients. J Pediatr Hematol Oncol.
    2005;27:627-629.
9. Borinstein SC, Pollard J, Winter L, Hawkins DS. Pegfilgrastim for prevention of chemotherapy-associated neutropenia in
    pediatric patients with solid tumors. Pediatr Blood Cancer. 2009;53:375-378.
10. André N, Kababri ME, Bertrand P, et al. Safety and efficacy of pegfilgrastim in children with cancer receiving
    myelosuppressive chemotherapy. Anticancer Drugs. 2007;18:277-281.
11. Dallorso S, Berger M, Caviglia I, et al. Prospective single-arm study of pegfilgrastim activity and safety in children with
    poor-risk malignant tumors receiving chemotherapy. Bone Marrow Transplant. 2008;42:507-513.
12. André N, Milano E, Rome A, Gentet JC. Safety of pegfilgrastim in children. Ann Pharmacother. 2008;42:290.

PBPC [NOT FDA-APPROVED INDICATION]
  Jagasia MH, Greer JP, Morgan DS, et al. Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem
   cell transplant: phase II study. Bone Marrow Transplant. 2005;35:1165-1169.
  Staber PB, Holub R, Linkesch W, et al. Fixed-dose single administration of pegfilgrastim vs. daily filgrastim in patients
   with haematological malignancies undergoing autologous peripheral blood stem cell transplantation. Bone Marrow
   Transplant. 2005;35:889-893.
  Vanstraelen G, Frere P, Ngirabacu MC, et al. Pegfilgrastim compared with filgrastim after autologous hematopoietic
   peripheral blood stem cell transplantation. Exp Hematol. 2006;34:382-388.
  Kroschinsky F, Holig K, Poppe-Thiede K, et al. Single-dose pegfilgrastim for the mobilization of allogeneic CD34+
   peripheral blood progenitor cells in healthy family and unrelated donors. Haematologica. 2005;90:1665-1671.
  Kroschinsky F, Holig K, Platzbecker U, et al. Efficacy of single-dose pegfilgrastim after chemotherapy for the mobilization
   of autologous peripheral blood stem cells in patients with malignant lymphoma or multiple myeloma. Transfusion.
   2006;46:1417-1423.
  Martino M, Pratico G, Messina G, et al. Pegfilgrastim compared with filgrastim after high-dose melphalan and autologous
   hematopoietic peripheral blood stem cell transplantation in multiple myeloma patients. Eur J Haematol. 2006;77:410-415.
  Merlin E, Zohar S, Jerome C, et al. Hematopoietic progenitor cell mobilization and harvesting in children with
   malignancies: do the advantages of pegfilgrastim really translate into clinical benefit. Bone Marrow Transplant.
   2009;43(12):919-925.
  Tricot G, Barlogie B, Zangari M, et al. Mobilization of peripheral blood stem cells in myeloma with either pegfilgrastim or
   filgrastim following chemotherapy. Haematologica. 2008;93:1739-1742.
  Russell N, Mesters R, Schubert J, et al. A phase 2 pilot study of pegfilgrastim and filgrastim for mobilizing peripheral blood
   progenitor cells in patients with non-Hodgkin’s lymphoma receiving chemotherapy. Haematologica. 2008;93(3):405-412.
  Ballestro A, Boy D, Gonella R, et al. Pegfilgrastim compared with filgrastim after autologous peripheral blood stem cell
   transplantation in patients with solid tumors and lymphomas. Ann Hematol. 2008;87:49-55.
  Kroschinsky F, Hölig K, Ehninger G. The role of pegfilgrastim in mobilization of hematopoietic stem cells. Transfus
   Apher Sci. 2008;38(3):237-244.
  Kobbe G, Bruns I, Fenk R, et al. Pegfilgrastim for PBSC mobilization and autologous haematopoietic SCT. Bone Marrow
   Transplant. 2009;43(9):669-677.
  Moog R. Management strategies for poor peripheral blood stem cell mobilization. Transfus Apher Sci. 2008;38:229-236.
  Bensinger W, DiPersio JF, McCarty JM. Improving stem cell mobilization strategies: future directions. Bone Marrow
   Transplant. 2009;43:181-195.
  Rhodes B, Anderlini P. Allogeneic peripheral blood stem cell collection as of 2008. Transfus Apher Sci. 2008;38:219-227.
  Willis F, Woll P, Theti D, et al. Pegfilgrastim for peripheral CD34+ mobilization in patients with solid tumours. Bone
   Marrow Transplant. 2009;43:927-934.
  Steidl U, Fenk R, Bruns I, et al. Successful transplantation of peripheral blood stem cells mobilized by chemotherapy and a
   single dose of pegylated G-CSF in patients with multiple myeloma. Bone Marrow Transplant. 2005;35:33-36.
AML [NOT FDA-APPROVED INDICATION]



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pegfilgrastim injection (Neulasta®)


   Sierra J, Szer J, Kassis J, et al. A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil
    recovery in patients treated for low-to-intermediate risk acute myeloid leukemia: results from a randomized, double-blind,
    phase 2 trial. BMC Cancer. 2008;10;8:195.
Other references available
   Braess J, Spiekermann K, Staib P, et al. Dose-dense induction with sequential high-dose cytarabine and mitoxantone (S-
    HAM) and pegfilgrastim results in a high efficacy and a short duration of critical neutropenia in de novo acute myeloid
    leukemia: a pilot study of the AMLCG. Blood. 2009;113:3903-3910.
   Lyman G, Lalla A, Barron R, Dubois RW. Cost-effectiveness of pegfilgrastim versus 6-day filgrastim primary prophylaxis
    in patients with non-Hodgkin’s lymphoma receiving CHOP-21 in United States. Curr Med Res Opin. 2009;25(2):401-411.
   Renwick W, Pettengell R, Green M. Use of filgrastim and pegfilgrastim to support delivery of chemotherapy. Twenty
    years of clinical experience. Biodrugs. 2009;23(3):175-186.
   Weycker D, Malin J, Kim J, et al. Risk of hospitalization for neutropenic complications of chemotherapy in patients with
    primary solid tumors receiving pegfilgrastim or filgrastim prophylaxis: a retrospective cohort study. Clin Ther.
    2009;31(5):1069-1080.




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