Trade Names:Neupogen- Injection 300 mcg/mL- Injection 300 mcg per 0.5 mL- Injection, prefilled SingleJect syringes 300 mcg per 0.5 mL- Injection, prefilled SingleJect syringes 480 mcg per 0.8 mL
Stimulates neutrophil production within bone marrow.
C max is 4 to 49 ng/mL (subcutaneous); T max is 2 to 8 h (subcutaneous).
Vd is about 150 mL/kg.
The half-life is about 3.5 h and Cl is 0.5 to 0.7 mL/min/kg.
Cancer patients receiving myelosuppressive chemotherapy; cancer patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; cancer patients receiving bone marrow transplant; patients with severe chronic neutropenia; peripheral blood progenitor cell (PBPC) collection and therapy in cancer patients.
Treatment of graft failure after bone marrow transplantation; neutropenia associated with myelodysplastic syndrome; hairy cell leukemia; aplastic anemia; AIDS; zidovudine- and other drug-induced neutropenia.
Hypersensitivity to Escherichia coli –derived proteins, filgrastim, or any component of the product.
IV/Subcutaneous 10 mcg/kg/day as an IV infusion of 4 or 24 h or as a continuous 24-h subcutaneous infusion. Administer first dose at least 24 h after cytotoxic chemotherapy and at least 24 h after bone marrow infusion.Dose adjustments
When absolute neutrophil count (ANC) is more than 1,000/mm 3 for 3 consecutive days, reduce dosage to 5 mcg/kg/day. Then if ANC remains more than 1,000/mm 3 for 3 more consecutive days, discontinue therapy. Then if ANC decreases to less than 1,000/mm 3 resume 5 mcg/kg/day; if ANC decreases to less than 1,000/mm 3 at any time during 5 mcg/kg/day administration, increase dosage to 10 mcg/kg/day and follow the above dosage adjustment steps.Myelosuppressive Chemotherapy
IV/Subcutaneous Administer no earlier than 24 h after cytotoxic chemotherapy. 5 mcg/kg/day as single daily injection by subcutaneous bolus, by short (15 to 30 min) IV infusion, or by continuous subcutaneous or IV infusion daily for up to 2 wk until ANC reaches 10,000/mm 3 ; may increase in increments of 5 mcg/kg for each chemotherapy cycle.Discontinuation
Therapy should be continued following chemotherapy until the postnadir ANC reaches 10,000/mm 3 . Discontinue if the ANC surpasses 10,000/mm 3 .Severe Chronic NeutropeniaCongenital neutropenia Starting dose
6 mcg/kg subcutaneously twice daily.Idiopathic or Cyclic Neutropenia Starting dose
5 mcg/kg as a single subcutaneous injection once daily.Dose adjustments
Chronic daily administration is required to maintain clinical benefit. Do not use ANC as the sole indication of efficacy. Individually adjust the dose based on the patient's clinical course and ANC.PBPC Collection/Therapy
Subcutaneous 10 mcg/kg/day as bolus subcutaneous injection or continuous infusion; start 4 days before first leukapheresis and continue until last leukapheresis.
Store vials and prefilled syringes in refrigerator (36° to 46°F). Avoid shaking. May allow injection to reach room temperature for a max of 24 h; discard any vial or syringe left at room temperature for more than 24 h.
Drugs that may potentiate the release of neutrophils, such as lithium, should be used with caution. Use with caution in conjunction with other drugs known to lower the platelet count.
Precipitate may form if diluted with saline.
None well documented.
Chest pain (5%); hypertension, hypotension (4%); cardiac events (eg, MI, arrhythmias) (3%).
Fatigue (11%); headache (7%); generalized weakness (4%).
Alopecia (18%); petechiae (17%); rash (12%); cutaneous vasculitis; exacerbation of preexisting skin disorders (eg, psoriasis).
Epistaxis (15%); sore throat (4%).
Nausea/vomiting (57%); diarrhea (14%); mucositis (12%); anorexia (9%); stomatitis, constipation (5%); peritonitis (2%).
Hematuria/proteinuria; renal insufficiency.
Increased neutrophil count (100%); decreased platelet counts (97%); mild to moderate anemia (65%); splenomegaly (30%); increased WBC (12%); severe hemorrhage (7%); thrombocytopenia (4%); acute myeloid leukemia, myelodysplastic syndrome (postmarketing [2% annually]); capillary leak syndrome.
Reversible elevations is alkaline phosphatase, lactate dehydrogenase, uric acid (27% to 58%).
Musculoskeletal symptoms (44%); medullary bone pain, mild to moderate bone pain (33%); skeletal pain (22%); arthralgia; osteoporosis.
Dyspnea (9%); cough (6%).
Neutropenic fever (13%); fever (12%); transfusion reactions (10%); pain (2%); injection-site reaction.
MonitorBone marrow transplant
Obtain CBC and platelet count at least 3 times/wk following marrow transplantation.Myelosuppressive chemotherapy
Obtain CBC, WBC, and platelet count prior to chemotherapy and 2 times/wk during filgrastim therapy.Severe chronic neutropenia
Obtain CBC with differential and platelet count 2 times/wk during first 4 wk of filgrastim therapy, and during the 2 wk following any dose adjustment; once stable, obtain once monthly for first year then at least quarterly thereafter. Perform bone marrow and cytogenetic evaluations annually in patients with congenital neutropenia.PBPC collection/therapy
Obtain neutrophil count after 4 days of filgrastim. Consider dose modification if WBC count greater than 100,000/mm 3 .
Category C .
Safety and efficacy in neonates and patients with autoimmune neutropenia of infancy not established.
Following myelosuppressive chemotherapy, no overall differences in safety and efficacy have been observed between subjects 65 yr of age and older compared with younger subjects. For other approved indications, data are insufficient to make a comparison.
Has been reported in neutropenic patients with sepsis.
Allergic-type reactions on initial or subsequent treatment have been reported rarely; generally, these have been characterized by systemic symptoms involving at least 2 body systems, most often skin (eg, rash), respiratory, and cardiovascular.
Do not administer filgrastim until at least 24 h after cytotoxic chemotherapy and at least 24 h after bone marrow infusion.
MI and arrhythmias have been reported. Use with caution in patients with preexisting cardiac conditions.
Do not use filgrastim in the period 24 h before through 24 h after administration of cytotoxic chemotherapy.
WBC counts of 100,000/mm 3 have been observed in about 2% of patients treated with filgrastim 5 mcg/kg/day. There are no reports of adverse events associated with this degree of leukocytosis; however, regular CBC monitoring is recommended.Premature discontinuation
A transient increase in neutrophil counts is typically seen 1 to 2 days after the start of therapy. For a sustained therapeutic response, therapy should be continued after chemotherapy until the postnadir ANC reaches 10,000/mm 3 . Therefore, premature discontinuation of therapy, prior to the time of recovery from the expected neutrophil nadir, generally is not recommended.
Confirm diagnosis before initiating therapy.
Use with caution; may cause sickle cell crisis.
Has been reported rarely. Evaluate patients reporting left upper abdominal and/or shoulder tip pain for enlarged spleen or splenic rupture.
Filgrastim is a growth factor; the possibility that filgrastim can act as a growth factor for any tumor type cannot be excluded.
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