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Utilization Review Policy

Subject: filgrastim injection (Neupogen®)

Date revised: 12/9/2009; selected revision 12/16/2009

DescriptionFilgrastim 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. It is approved by the Food and Drug Administration (FDA) for the following indications.1

Cancer patients receiving myelosuppressive chemotherapy Patients with acute myeloid leukemia (AML) receiving induction or consolidation

chemotherapy Cancer patients receiving bone marrow transplant (BMT) Patients undergoing peripheral blood progenitor cell (PBPC) collection and cancer

patients receiving PBPC transplantationPatients with severe chronic neutropenia

Filgrastim is also used for many off-label (not FDA approved) indications.

The National Comprehensive Cancer Network (NCCN) recommends use for filgrastim for prophylaxis of febrile neutropenia based on the patient’s risk of developing febrile neutropenia (high, intermediate, and low) and the intent of chemotherapy (curative/adjuvant, prolong survival/quality of life, and symptom management/quality of life).2 This is in adults with solid tumors and nonmyeloid malignancies. NCCN also has recommendations for secondary prophylaxis and to treat febrile neutropenia.

Filgrastim is available as a preservative free solution in single use vials and prefilled syringes. The single use vials contain either 300 mcg or 480 mcg of filgrastim in 1.0 mL or 1.6 mL, respectively. The single use syringes contain either 300 mcg or 480 mcg of filgrastim in 0.5 mL or 0.8 mL, respectively. Depending on the indication, filgrastim is given by subcutaneous (SC) bolus injection, by short intravenous (IV) infusion (15 to 30 minutes), or by continuous SC or continuous IV infusion.1

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.

Filgrastim is prescribed by an oncologist or hematologist, and

Patient has a nonmyeloid malignancy, and

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filgrastim (Neupogen)

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 guidelines 2 and in ASCO guidelines 3 . These references may not be a complete list, as new regimens are being developed. ORPatient 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 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

ORPatient has had a neutropenic complication from prior chemotherapy and did not receive prophylaxis with a CSF and a reduced dose may compromise treatment outcome. OR Patient has febrile neutropenia AND is at high risk for infection associated complications OR has any one of the following factors that predict clinical deterioration:2-3

Neutropenia expected to be > 10 days in duration2

Profound neutropenia [absolute neutrophil count [ANC] < 100 cells/mm3]2

Age greater than 65 years2

Uncontrolled primary disease Pneumonia2

Hypotension and multiorgan dysfunction (sepsis syndrome)2

Invasive fungal infection2

Hospitalization at the time of the development of fever2

Other clinically documented infections2

Note: This includes using filgrastim to maintain dose intensity (dose intense chemotherapy) and to support dose dense (treatment is given more frequently such as every 2 weeks instead of every 3 weeks) chemotherapy. Filgrastim is used to prevent neutropenia (primary

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prophylaxis) and may also be used for treatment of neutropenia once it has occurred (secondary treatment).

Dosing in cancer patients receiving myelosuppressive chemotherapy: In adults and children, the recommended starting dose of filgrastim is 5 mcg/kg/day, administered as a single daily injection by SC bolus injection, by short IV infusion (15 to 30 minutes), or by continuous SC or continuous IV infusion.1 The preferred route of administration is SC.2

Doses may be increased in increments of 5 mcg/kg for each chemotherapy cycle, according to the duration and severity of the ANC nadir.1 Filgrastim should be given no earlier than 24 hours after the administration of cytotoxic chemotherapy.1-2 Filgrastim should not be administered in the period 24 hours before the administration of chemotherapy. Dosing is continued until an ANC is adequate (2000-3000/mm3 or 2-3 X 109/L).3 The product labeling states filgrastim should be administered daily for up to 2 weeks, until the ANC has reached 10,000/mm3 following the expected chemotherapy-induced neutrophil nadir. The duration of filgrastim therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed.

Product labeling for filgrastim states that therapy should be discontinued if the ANC surpasses 10,000/mm3 after the expected chemotherapy-induced neutrophil nadir. In phase 3 trials, efficacy was observed at doses of 4 to 8 mcg/kg/day. Because the duration of neutropenia often increases with each cycle of chemotherapy, longer periods of filgrastim therapy may be required for later chemotherapy cycles than for early cycles.4

Filgrastim has been used in children aged 3 months to 18 years without unusual adverse effects.4 However, safety and efficacy in neonates or patients with autoimmune neutropenia of infancy have not been established.

Initial approval/extended approval in cancer patients receiving myelosuppressive chemotherapy: Initial approval is for 6 months.

Duration of therapy in cancer patients receiving myelosuppressive chemotherapy: therapy may be continued as long as the patient is on myelosuppressive chemotherapy.

Labs/Diagnostics required: Baseline complete blood count (CBC) and platelet count as needed to follow guidelines for filgrastim use.

Waste management: Single use vials and syringes contain 300 mcg and 480 mcg. Initial doses are 5 mcg/kg daily, and should be rounded to the nearest vial size per weight limits. Doses are usually given daily for 6 to 10 days after chemotherapy. The dose can be increased from 5 mcg/kg to 10 mcg/kg in patients who had an inadequate response during the previous cycle.

Exclusions: cancer patients receiving myelosuppressive chemotherapy. See more below. Afebrile neutropenic patients who do not meet the criteria above.3

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Prophylactic use in patients on concurrent chemotherapy and radiation therapy.2 Use before or concurrently with chemotherapy.

2. AML: Indicated for adults with AML receiving induction or repeat induction or after consolidation chemotherapy treatment who meet all of the following criteria.

Filgrastim is prescribed by an oncologist or hematologist.

Note: Some patients with AML may receive PBPC transplantation and require filgrastim. Use criteria number 4, if applicable.

Dosing in AML: Dosing is the same as in cancer patients receiving myelosuppressive chemotherapy. See above. Following induction chemotherapy, 5 mcg/kg is given daily from 24 hours after the last dose of chemotherapy until neutrophil recovery (ANC 1000/mm3 for 3 consecutive days or 10,000/mm3 for 1 day or a maximum of 35 days). Also used in consolidation chemotherapy (post remission chemotherapy).

Initial approval/extended approval in AML: Initial approval is for 6 months.

Duration of therapy in AML: therapy may be continued as long as the patient is on consolidation chemotherapy. Some patients will receive an autologous or allogeneic hematopoietic stem cell transplantation and may require filgrastim after PBPC. See Criteria 4 below.

Labs/Diagnostics required: Baseline CBC and platelet count and as needed to follow guidelines for filgrastim use.

Waste management: Single-use vials and syringes contain 300 mcg and 480 mcg. Initial doses are 5 mcg/kg daily. Doses are usually given daily for 6 to 10 days after chemotherapy. The dose can be increased from 5 mcg/kg to 10 mcg/kg in patients who had an inadequate response during the previous cycle.

Exclusions: AML. See more below. Administration prior to or concurrently with chemotherapy for AML (use is

considered after chemotherapy is complete). Use for priming effects in AML.2

Prophylactic use in patients on concurrent chemotherapy and radiation therapy. Use before or concurrent with chemotherapy and radiotherapy.

3. Bone marrow transplant (BMT) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by autologous or allogeneic BMT. These patients are not addressed in this document.

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4. PBPC collection or cancer patients who have received therapy with PBPC (autologous). Indicated in patients (adults and children) with cancer or healthy donors who are undergoing mobilization of hematopoietic progenitor cells and in cancer patients (adults and children) post autologous PBPC transplantation who meet all of the following criteria.


Dosing in cancer patients or healthy donors undergoing mobilization of PBPC: The recommended dose of filgrastim for the mobilization of PBPC is 10 mcg/kg/day SC, either as a bolus or continuous infusion. However, some patients may require higher doses of filgrastim (e.g., up to 20 mcg/kg/day SC). Filgrastim is given for at least 4 days before the first leukapheresis procedure and continued until the last leukapheresis. According to the package insert, although the optimal duration of filgrastim administration and leukapheresis schedule have not been established, administration of filgrastim for 6 to 7 days with leukapheresis on days 5, 6, and 7 was found to be safe and effective in the pivotal clinical trials where cancer patients were undergoing PBPC collection for autologous transplantation. Neutrophil counts should be monitored after 4 days of filgrastim, and filgrastim dose modification should be considered for patients who develop a white blood cell (WBC) count > 100,000/mm3.1 Recent reviews indicate 5 days of filgrastim 10 mcg/kg/day is adequate.5-6

Some patients may require a longer duration of therapy (see duration of therapy section).

Poor mobilizers (e.g., patients who fail to mobilize an adequate number of stem cells on the first attempt; patients with Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, and preleukemic syndromes; recent chemotherapy or radiation), may benefit from using filgrastim 12.5 to 50 mcg/kg/day, adding sargramostim (Leukine) to filgrastim, adding plerixafor (Mozobil) injection, or mobilization with chemotherapy plus filgrastim.6

Dosing in cancer patients post autologous PBPC transplantation: In the pivotal trials of filgrastim reported in the package insert for mobilization of PBPC, filgrastim was also administered after reinfusion of collected cells.1 In these studies doses were 5 to 24 mcg/kg/day after reinfusion of the collected cells until a sustainable ANC (> 500/mm3) were attained. The median number of days to attaining ANC > 500/mm3 were 9 to 11 days but ranged from 7 to 63 days. Most patients achieved engraftment (defined as platelet count ≥ 20,000/mm3) by day 28; the range was 7 to 63 days. A few patients did not achieve engraftment.

Initial approval/extended approval in PBPC: Cancer patients or healthy donors undergoing mobilization of PBPC: For unrelated healthy donors, 5 days of therapy with filgrastim 10 mcg/kg/day are used.1,5-6 For cancer patients, 5 to 7 days of filgrastim 10 mcg/kg/day are given once daily. Exceptions may be made based upon transplant center protocols.

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Cancer patients post autologous PBPC transplantation: 14 days or until the ANC is > 1500 cells/mm3 for 3 consecutive days.1 Exceptions may be made based upon transplant center protocols.

Duration of therapy: Cancer patients or healthy donors undergoing PBPC collection: 5 days. The National Marrow Donor Program protocol gives filgrastim for 4 (in patients weighing < 35 kg) or 5 consecutive days in unrelated donors (allogeneic transplantation).5 In some instances, patients may require a longer duration of therapy (e.g., cancer patients heavily pretreated with chemotherapy, healthy patients in which a higher number of cells are needed due to the type of transplantation). Exceptions may be made based on transplant center protocols. Cancer patients post autologous PBPC transplantation: 14 days. Approve for another 14 days if ANC is not at a sustainable level.1 Most patients have a response after 28 days of filgrastim.

Labs/Diagnostics required: Baseline CBC and platelet count as needed for filgrastim use. In persons undergoing PBPC collection, neutrophil counts should be monitored after 4 days of filgrastim, and filgrastim dose modification should be considered for those patients who develop a WBC count > 100,000/mm3.1

Waste management: Single use vials and syringes contain 300 mcg and 480 mcg. Since the agent is based on mcg/kg, assess the dosage and the vial or syringe.

Exclusions: PBPC. See more below. Use post allogeneic PBPC transplantation.

5. Severe chronic neutropenia. Indicated for symptomatic patients (adults, infants, children, and adolescents) with congenital neutropenia (e.g., Kostmann’s syndrome, Shwachmann-Diamond syndrome, myelokathexis), cyclic neutropenia, or idiopathic neutropenia who meet all of the following.

Filgrastim is prescribed by or in consultation with a hematologist, and

Other diseases associated with neutropenia have been ruled out.

Dosing in severe chronic neutropenia: The starting dose in congenital neutropenia is 6 mcg/kg twice daily (BID) by SC injection.1,7 For idiopathic or cyclic neutropenia, the starting dose is 5 mcg/kg once daily. The dose is adjusted based on the clinical response and the ANC. Dose Adjustments: Chronic daily administration is required to maintain clinical benefit.1 ANC should not be used as the sole indication of efficacy. The dose should be individually adjusted based on the patients' clinical course, such as reduced number of infections and frequency of fever, as well as ANC. In the severe chronic neutropenia postmarketing surveillance study, the median daily doses of filgrastim were: 6.0 mcg/kg

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(congenital neutropenia), 2.1 mcg/kg (cyclic neutropenia), and 1.2 mcg/kg (idiopathic neutropenia).1 In rare instances, patients with congenital neutropenia have required doses of filgrastim > 100 mcg/kg/day. In the phase 3 pivotal trial, filgrastim doses were 2.3 to 40 mcg/kg/day in patients with congenital neutropenia; 0.6 to 11.5 mcg/kg/day in idiopathic neutropenia; and 0.5 to 6 mcg/kg/day in cyclic neutropenia.1 NCCN guidelines state that observational studies show that patients with idiopathic and cyclic neutropenia generally respond to low-dose daily, alternative day, or thrice-per-week filgrastim (1 to 3 mcg/kg/day SC).2 Patients with congenital neutropenia generally require somewhat higher doses of 3 to 10 mcg/kg/day.

Initial approval/extended approval in severe chronic neutropenia: Initial approval is for 2 months to allow adjustment of dosage and to assess for response. Approve for an additional 12 months of therapy if the patient has responded (e.g., ANC has increased; reduced frequency of fever, inflammation, and infections; reduced antibiotic use) as determined by the prescribing physician.

Duration of therapy in patients with severe chronic neutropenia: therapy is chronic.

Labs/Diagnostics required: Prior to starting filgrastim therapy, serial CBCs with differential and platelet counts and an evaluation of bone marrow morphology and karyotype must be performed.1 The use of filgrastim prior to confirmation of severe chronic neutropenia may impair diagnostic efforts and may thus impair or delay evaluation and treatment of an underlying condition, other than severe chronic neutropenia, causing the neutropenia.

Waste management: Single use vials and syringes contain 300 mcg and 480 mcg. Dosage in severe chronic neutropenia is based on mcg/kg of body weight and the dose may need to be adjusted with changes in weight.

Exclusions: severe chronic neutropenia. See below.

6. Neutropenia associated with HIV or AIDS. Indicated in adults with HIV or AIDS with neutropenia who meet all of the following criteria.8-14 [NOT FDA-APPROVED INDICATION]

Prescribed by, or in consultation with, an infectious disease physician, a hematologist, or a physician that specializes in the management of HIV/AIDS, and

Patient is neutropenic, and

Medications that cause neutropenia have been assessed for discontinuation, dose reduction, or possible alteration.

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Dosing in patients with HIV or AIDS: 5 to 10 mcg/kg/day for 2 to 4 weeks.4

Initial approval/extended approval for neutropenia in HIV/AIDS: Approve for a one month time period.

Duration of therapy for neutropenia in HIV or AIDS: use may be long-term due to the nature of the disease/and or the need to continue medication therapy.

Labs/Diagnostics required: CBC and ANC as required for filgrastim use.

Waste management: Single use vials and syringes contain 300 mcg and 480 mcg. Dosage in based on mcg/kg body weight and the dose may need to be adjusted.

Exclusions: neutropenia in HIV or AIDS. See more below. Routine long-term use in HIV/AIDS without neutropenia.

7. Myelodysplastic syndrome (MDS). Indicated in adults with MDS who meet all of the following criteria. [NOT FDA-APPROVED INDICATION]


Dosing in MDS: The dose range is 1 to 2 mcg/kg 1 to 3 times per week subcutaneously 15 or 5 mcg/kg once daily SC or IV.16

Initial approval/extended approval in MDS: Approval is for up to one month until neutropenia resolves and then as needed.

Duration of therapy in patients with MDS: duration of therapy will vary per the response and is usually intermittent vs. chronic.

Labs/Diagnostics required: Monitor CBC and ANC as required for filgrastim use.

Waste Management: Single use vials and syringes contain 300 mcg and 480 mcg. Dosage in MDS is based on mcg/kg of body weight and the dose may need to be adjusted with changes in weight.

Exclusions: MDS. See more below. Routine long-term use in MDS.15

8. Aplastic anemia. Indicated in patients (adults and children) with aplastic anemia who meet all of the following criteria.17-22 [NOT FDA-APPROVED INDICATION]

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Filgrastim is prescribed by an oncologist or hematologist, and

Patient is severely neutropenic OR if the patient has a severe systemic infection that is not responding to intravenous antibiotics and anti-fungal drugs.17

Dosing in aplastic anemia: The dose range is 5 mcg/kg/day SC once daily or 1-3 times per week SC.17

Initial approval/extended approval in aplastic anemia: Approval is for one week.17 If there is no increase to the neutrophil count, then the agent should be discontinued. If there is a response approve for up to one month.

Duration of therapy in patients with aplastic anemia: the duration of therapy will vary per the response and is usually intermittent vs. chronic.

Labs/Diagnostics required: Monitor CBC and ANC as needed for filgrastim use.

Waste Management: Single use vials and syringes contain 300 mcg and 480 mcg. Dosage in aplastic anemia is based on mcg/kg of body weight and the dose may need to be adjusted with changes in weight.

Exclusions: aplastic anemia. See more below. Routine long-term use in aplastic anemia.17 Patients are not neutropenic or do not have a severe systemic infection that is not

responding to intravenous antibiotics or antifungals. Use after neutropenia has resolved.

9. Medication-induced (non-chemotherapy) neutropenia (agranulocytosis): Indicated in patients with medication-induced neutropenia (agranulocytosis) who meet all of the following criteria.23-30 [NOT FDA-APPROVED INDICATION]

Patients has an neutropenia, defined as an ANC < 500 cells/mm3 or < 0.5 X 109 cells/L, and

The drug that is believed to have caused the neutropenia has been discontinued. Some of the more frequently associated causes of medication-induced neutropenia in the literature include carbimazole, clozapine, dapsone, dipyrone, methimazole, penicillin G, procainamide, prophylthiouracil, rituximab, sulfasalazine, and ticlopidine.23-25

Dosing in medication-induced neutropenia (agranulocytosis): The dose range is 5 to 10 mcg/kg/day SC or 300 mcg/day SC once daily.

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Initial approval/extended approval in medication-induced neutropenia (agranulocytosis): Approval is for two weeks, as most times the ANC recovers in about one week. If there is a response, approve for an additional 2 weeks.

Duration of therapy in patients with medication-induced neutropenia (agranulocytosis): the duration of therapy should not be on a chronic basis.



Exclusions: medication-induced neutropenia (agranulocytosis). See more below. Routine long-term use in medication-induced neutropenia.2 Use after neutropenia has resolved.

10. Acute lymphocytic leukemia (ALL). Filgrastim is indicated in patients with ALL after the completion of the initial first few days of chemotherapy of the initial induction or first post remission course and for those who meet the criteria below.3 [NOT FDA-APPROVED INDICATION]


Dosing in ALL: The dose seems to vary but in general is in the range of 5-10 mcg/kg/d SC.31

Initial approval/extended approval in ALL: Approval is for up to one month.

Duration of therapy in patients with ALL: the recommendation is to administer for the initial first few days after the completion of the chemotherapy of the initial induction or first post remission course.2



Exclusions: ALL. See below.

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11. Radiation injury. Indicated in patients (adults and children) with acute intentional or accidental radiation injury who meet all of the following criteria.2,32-33 [NOT FDA-APPROVED INDICATION]

Filgrastim is prescribed by a physician with expertise 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.32-33

Dosing in radiation injury: Filgrastim 5 mcg/kg/day SC.32-33

Initial approval/extended approval in radiation injury: Initial approval is for 1 month.

Duration of therapy in radiation injury: Filgrastim may be withdrawn when the ANC reaches > 1000 cells/mm3 or > 1.0 X 109 cells/L after recovery from the nadir.


Waste Management: Single use vials and syringes contain 300 mcg and 480 mcg. Dosage in radiation injury is based on mcg/kg of body weight and the dose may need to be adjusted with changes in weight.

Exclusions: radiation injury. See more below. Radiation dose is less than 2 Grays in children and adults ≥ 60 years or in those who

have had major trauma injuries or burns.33 Radiation dose is less than 3 Grays in adults aged < 60 years.33

12. Radiation therapy. Indicated in patients (adults and children) receiving radiation therapy alone if prolonged delays secondary to neutropenia are expected if the patient meets all of the following criteria.3,34-36 [NOT FDA-APPROVED INDICATION]

Filgrastim is prescribed by an oncologist, radiologist, or radiation oncologist.

Dosing in radiation therapy: Filgrastim 5 mcg/kg/day SC or 300 mcg SC daily.

Initial approval/extended approval in radiation therapy: Initial approval is for 6 months.

Duration of therapy in radiation therapy: filgrastim may be withdrawn when the ANC reaches > 1000 cells/mm3 or > 1.0 x 109 cells/L after recovery from the nadir.


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Waste Management: Single use vials and syringes contain 300 mcg and 480 mcg. Dosage in radiation injury is based on mcg/kg of body weight and the dose may need to be adjusted with changes in weight.

Exclusions: in radiation therapy. See more below. Patient is also receiving chemotherapy.

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Exclusions for all: Patients with a known hypersensitivity to Escherichia coli-derived protein. Use in routine infection prophylaxis. Patients receiving concomitant chemotherapy and radiation therapy.1-2

Use in Acute Promyelocytic Leukemia (APL).37

AbbreviationsAIDS = Acquired Immunodeficiency VirusAML = acute myelogenous leukemiaANC = Absolute neutrophil countASCO = American Society of Clinical OncologyBID = twice dailyBMT = bone marrow transplantCBC = complete blood countCHOP = cyclophosphamide, doxorubicin, vincristine, and prednisoneCSF = colony stimulating factorFDA = Food and Drug AdministrationG-CSF = granulocyte colony stimulating factorHIV = human immunodeficiency virusIV = intravenous MDS = myelodysplastic syndromemL = milliliterMDS = myelodysplastic syndromeNCCN = National Comprehensive Cancer NetworkPBPC = peripheral blood progenitor cell SC = subcutaneousWBC = White Blood Cell

References1. Neupogen® [package insert]. Thousand Oaks, CA: Amgen, Inc.; September 2007. 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;24:3187-3205. Accessed on September 22, 2009 online at http://www.jco.org/cgi/reprint/JCO.2006.06.4451v2.pdf

4. AHFS Drug Information. Filgrastim pages 1592-1600. 5. Pulsipher MA, Chitphakdithai P, Miller JP, et al. Adverse events among 2408 unrelated donors of peripheral blood stem

cells: results of a prospective trial from the National Marrow Donor Program. Blood. 2009;113:3604-3611. 6. Pusic I, DiPersio JF. The use of growth factors in hematopoietic stem cell transplantation. Curr Pharm Des.

2008;14(20):1950-1961.7. Dale DC, Bonilla MA, Davis MW, et al. A randomized controlled phase III trial of recombinant human granulocyte colony-

stimulating factor (filgrastim) for treatment of severe chronic neutropenia. Blood. 1993;81:2496-2502.HIV/AIDS [NOT FDA-APPROVED INDICATION]8. Kuritzkes DR, Parenti D, Ward DJ, et al, and the G-CSF 930101 study group. Filgrastim prevents severe neutropenia and

reduces infective morbidity in patients with advanced HIV infection: results of a randomized, multicenter controlled trial. AIDS. 1998;12:65-71.

9. Jaresko GS. Etiology of neutropenia in HIV-infected patients. Am J Health Syst Pharm. 1999;56(Suppl 5):S5-S8.

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10. Mitsuyasu R. Prevention of bacterial infections in patients with advanced HIV infection. AIDS. 1999;13(Suppl 2):S19-S23.

11. Kurizkes DR. Neutropenia, neutrophil dysfunction, and bacterial infection in patients with human immunodeficiency virus disease: the role of granulocyte colony-stimulating factor. Clin Infect Dis. 2000;30:256-260.

12. Hermans P, Rozenbaum W, Joy A, et al, and the G-CSF 92105 Study Group. Filgrastim to treat neutropenia and support myelosuppressive medication dosing in HIV infection. AIDS. 1996;10:1627-1633.

13. Nielsen SD, Sorensen TU, Aladdin H, et al. The effect of long-term treatment with granulocyte colony-stimulating factor on hematopoiesis in HIV-infected individuals. Scand J Immunol. 2000;52:298-303.

14. Kaplan JE, Benson C, Holmes KH Brooks JT, Pau A, Masur H; Centers for Disease Control and Prevention (CDC); National Institutes of Health; HIV Medicine Association for the Infectious Diseases Society of America. Guidelines for prevention and treatment of opportunistic infection in HIV-infected adults and adolescents. Recommendations from the CDC, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. MMWR Recomm Rep. 2009; April 10;58(RR-4):1-207.

MDS [NOT FDA-APPROVED INDICATION]15. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Myelodysplastic syndromes.

Version 2.2010. 16. Jadersten M, Montgomery SM, Dybedal I, et al. Long-term outcome of treatment of anemia in MDS with erythropoietin

and G-CSF. Blood. 2005;106:803-811. Aplastic anemia [NOT FDA-APPROVED INDICATION]17. Marsh JCW, Ball SE, Cavenagh J, et al, Writing Group: British Committee for Standards in Haematology. Guidelines for

the diagnosis and management of aplastic anemia. Br J Haematol. 2009;147:43-70. 18. Imamura M, Kobayashi M, Kobayashi S, et al. Combination therapy with recombinant human granulocyte colony

stimulating factor and erythropoietin in aplastic anemia. Am J Hematol. 1995;48:29-33. 19. Bessho M, Hirashima K, Asano S, et al. Treatment of the anemia of aplastic anemia patients with recombinant human

erythropoietin in combination with granulocyte colony-stimulating factor: a multicenter, randomized controlled study. Eur J Haematol. 1997;58:265-272.

20. Meidlinger P, Knobl P, Jager U, et al. Granulocyte colony-stimulating factor-supported combined immunosuppressive therapy (antilymphocyte globulin, cyclosporine, and methylprednisolone) in patients with aplastic anemia: tolerability, efficacy and changes in the progenitor cell compartment. Ann Hematol. 1999;78:299-304.

21. Matsuo Y, Iwanaga M, Mori H, et al. Recovery of hematopoietic progenitor cells in patients with severe aplastic anemia who obtained good clinical response with a combination therapy of immunosuppressive agents and recombinant human granulocyte colony-stimulating factor. Int J Hematol. 2000;72:37-43.

22. Fuhrer M, Rampf U, Baumann I, et al, for the German/Austrian Aplastic Anemia Working Group. Immunosuppressive therapy for aplastic anemia in children: a more severe disease predicts better survival. Blood. 2005;106:2102-2104.

Medication-induced neutropenia [NOT FDA-APPROVED INDICATION]23. Andersohn F, Konzen C, Garbe E. Systematic review: Agranulocytosis induced by nonchemotherapy drugs. Ann Intern

Med. 2007;146:657-665. 24. Beaushesne MF, Shalansky SJ. Nonchemotherapy drug-induced agranulocytosis: a review of 118 patients treated with

colony-stimulating factors. Pharmacother. 1999;19(3):299-305. 25. Bhatt V, Saleem A. Review: Drug-induced neutropenia-pathophysiology, clinical features, and management. Ann Clin Lab

Sci. 2004;34(2):131-136.26. Wickramanayake PD, Scheid C, Josting A, et al. Use of granulocyte colony-stimulating factor (filgrastim) in the treatment

of non-cytotoxic drug-induced agranulocytosis. Eur J Med Res. 1995;1996;1:153-156. 27. Mani S, Barry M, Concato J. Granulocyte-colony stimulating factor therapy in drug-induced agranulocytosis. Arch Intern

Med. 1993;153:2500-2501.28. Tesfa D, Keisu M, Palblad J. Idiosyncratic drug-induced agranulocytosis: possible mechanism and management. Am J

Hematol. 2009;84:428-434. 29. Castanheira D, Marzella M, Skirvin JA. Administration of filgrastim in two patients with drug-induced agranulocytosis.

Pharmacother. 1998;18(6):1347-1351. 30. Hagg S, Rosenius S, Spigset O. Long-term combination treatment with clozapine and filgrastim in patients with clozapine-

induced agranulocytosis. Int Clin Psychopharmacol. 2003;18:173-174. Acute Leukemia [NOT FDA-APPROVED INDICATION]31. Holdsworth, MT, Mathew P. Efficacy of colony-stimulating factors in acute leukemia. Ann Pharmacother. 2001;35:92-

108.Radiation Injury [NOT FDA-APPROVED INDICATION]32. Radiation Injury Transplant Network. Acute Radiation Syndrome Treatment guidelines. November 16, 2006. Accessed

11/13/2009 at http://www.nmdp.org/RITN/GUIDELINES/DOCS/ars_treatment_guidel.pdf33. Waselenko JK, Macvittie TJ, Bladely WF, et al. Medical management of the acute radiation syndrome: recommendations of

the strategic national stockpile radiation working group. Ann Intern Med. 2004;140:1037-1051.

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