• Prevention of febrile neutropenia and associated infection in patients who have received bone marrow–depressing antineoplastics for the treatment of nonmyeloid malignancies.
• Reduction of time for neutrophil recovery and duration of fever in patients undergoing induction and consolidation chemotherapy for acute myelogenous leukemia.
• Reduction of time to neutrophil recovery and sequelae of neutropenia in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation.
• Mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.
• Management of severe chronic neutropenia.
• Survival improvement in patients acutely exposed to myelosuppressive doses of radiation.

Unlabeled Use:

• Neutropenia associated with HIV infection.
• Neonatal neutropenia.

Contraindicated in:

• Hypersensitivity to filgrastim or Escherichia coli-derived proteins.

Use Cautiously in:

• Congenital neutropenia (↑ risk of myelodysplastic syndrome or acute myeloid leukemia)
• Patients with breast or lung cancer receiving chemotherapy and/or radiotherapy (↑ risk of myelodysplastic syndrome or acute myeloid leukemia)
• Patients with sickle cell disease (↑ risk of sickle cell crisis)
• Malignancy with myeloid characteristics
• Pre-existing cardiac disease
• OB: Use only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant.

CV: aortitis, vasculitis.

EENT: hemoptysis.

GI: SPLENIC RUPTURE, splenomegaly.

GU: glomerulonephritis.

Hemat: ACUTE MYELOID LEUKEMIA, excessive leukocytosis, MYELODYSPLASTIC SYNDROME, sickle cell crises, thrombocytopenia.

Local: pain at injection site.

MS: medullary bone pain.

Resp: ACUTE RESPIRATORY DISTRESS SYNDROME, pulmonary infiltrates.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS).

Drug-Drug:

• Simultaneous use with antineoplastics may have adverse effects on rapidly proliferating neutrophils — avoid use for 24 hr before and 24 hr after chemotherapy.
• Lithium may potentiate the release of neutrophils; concurrent use should be undertaken cautiously.

• Solution for injection (prefilled syringes): 300 mcg/0.5 mL; 480 mcg/0.8 mL;
• Solution for injection (vials): 300 mcg/1 mL; 480 mcg/1.6 mL;

After Myelosuppressive Chemotherapy

• IV, SC (Adults and Children): 5 mcg/kg/day as a single SUBQ injection, by short IV infusion, or via continuous IV infusion for up to 2 wk or until ANC reaches 10,000/mm³. Initiate at least 24 hr after chemotherapy. Dose may be ↑ by 5 mcg/kg during each cycle of chemotherapy, depending on blood counts.

After Bone Marrow Transplantation

• IV (Adults): 10 mcg/kg/day as a continuous IV infusion for up to 24 hr; initiate at least 24 hr after chemotherapy and at least 24 hr after bone marrow transplantation. Subsequent dose is adjusted according to blood counts.

Peripheral Blood Progenitor Cell Collection and Therapy

• SC (Adults): 10 mcg/kg/day for at least 4 days before first leukapheresis and continued until last leukapheresis; Discontinue if WBC >100,000 cells/mm³.

Severe Chronic Neutropenia

• SC (Adults): Congenital neutropenia: 6 mcg/kg twice daily. Idiopathic/cyclical neutropenia: 5 mcg/kg daily (↓ if ANC remains >10,000/mm³).

After Myelosuppressive Radiation

• SC (Adults): 10 mcg/kg once daily; initiate as soon as possible after exposure to radiation doses greater than 2 gray (Gy); continue until ANC remains >1000/mm³ for 3 consecutive blood counts (performed every 3 days) or is >10,000/mm³ after a radiation-induced nadir.

Neonatal Neutropenia

• IV, SC (Neonates): 5–10 mcg/kg/day once daily for 3–5 days.

Granix, Neupogen, Nivestym, Releuko, Zarxio

• A glycoprotein, filgrastim binds to and stimulates immature neutrophils to divide and differentiate. Also activates mature neutrophils.

• Decreased incidence of infection in patients who are neutropenic from chemotherapy or other causes.
• Improved harvest of progenitor cells for bone marrow transplantation.
• Improved survival in patients exposed to myelosuppressive doses of radiation

Therapeutic Classification: colony-stimulating factors

Absorption: Well absorbed after SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: Adults: 3.5 hr; Neonates: 4.4 hr.

Grastofil

†Return of neutrophil count to baseline.

• Explain purpose of filgrastim to patient. Instruct patient and caregiver on correct technique for injection, care and disposal of equipment. Advise patient to notify health care professional regarding when to give next dose if a dose is missed. Instruct patient and caregiver to read Instructions for Patients and Caregivers before starting therapy and with each Rx refill in case of changes.
• Instruct patient to notify health care professional immediately if signs and symptoms of spleen enlargement or rupture, allergic reaction, ARDS, glomerulonephritis (swelling of face or ankles, dark colored urine or blood in urine, decrease in urine production), MDS, AML, or vasculitis (skin redness, purple spots on skin) occur. Discuss risk of sickle cell crisis with patients with sickle cell disease before administering.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Home Care Issues: Instruct patient on correct technique and proper disposal for home administration. Caution patient not to reuse needle, vial, or syringe. Provide patient with a puncture-proof container for needle and syringe disposal.

fil-GRA-stim

NDC Code^*

• 55513- Amgen Inc
  • 55513-209- NEUPOGEN
    • 55513-209-10- 10 SYRINGE in 1 BOX (55513-209-10) >.8 mL in 1 SYRINGE (55513-209-01)

• 55513- Amgen Inc
  • 55513-209- NEUPOGEN
    • 55513-209-91- .8 mL in 1 SYRINGE (55513-209-91)

• 55513- Amgen Inc
  • 55513-530- NEUPOGEN
    • 55513-530-10- 10 VIAL in 1 PACKAGE (55513-530-10) > 1 mL in 1 VIAL (55513-530-01)

• 55513- Amgen Inc
  • 55513-546- NEUPOGEN
    • 55513-546-10- 10 VIAL in 1 BOX (55513-546-10) > 1.6 mL in 1 VIAL (55513-546-01)

• 55513- Amgen Inc
  • 55513-924- NEUPOGEN
    • 55513-924-10- 10 SYRINGE in 1 BOX (55513-924-10) >.5 mL in 1 SYRINGE (55513-924-01)

• 55513- Amgen Inc
  • 55513-924- NEUPOGEN
    • 55513-924-91- .5 mL in 1 SYRINGE (55513-924-91)