Recommended Dose: Cancer Patients Receiving Myelosuppressive Chemotherapy: The recommended starting dose of Filgrastim is 5 μg/kg/day, administered as a single daily injection by SC bolus injection or by rapid intravenous infusion (15-30 minutes). A complete blood count and platelet count should be obtained before instituting Filgrastim therapy, and monitored twice weekly during therapy. Doses may be increased in increments of 5 μg/kg for each chemotherapy cycle, according to the duration and severity of the absolute neutrophil count nadir.
Filgrastim should be administered daily for up to 2 weeks, until the absolute neutrophil count 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. Filgrastim therapy should be discontinued if the ANC surpasses 10,000/mm3 after the expected chemotherapy-induced neutrophil nadir.
Cancer Patients Receiving Bone Marrow Transplant: The recommended dose of Filgrastim following bone marrow transplant is 10 μg/kg/day given as an intravenous infusion of 4 to 24 hours. The first dose of Filgrastim should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion. During the period of neutrophil recovery, the daily dose of Filgrastim should be titrated against the neutrophil response as follows: When ANC >1,000/mm3 for 3 consecutive days the Filgrastim dose should be reduced to 5 μg/kg/day.
If ANC remains >1,000/mm3 for 3 more consecutive days after the dose reduction should stop treatment, once ANC decreases to <1,000/mm3 the treatment should be resumed at 5 μg/kg/day.
If ANC decreases to <1,000/mm3 at any time during the 5 μg/kg/day administration, Filgrastim should be increased to 10 μg/kg/day.
The treatment should be administered for 14 days consecutives.
Cancer Patients Undergoing Mobilization Procedure and Collection of Hematopoietic Progenitor Cells: The recommended dose of Filgrastim for the mobilization of PBPC is 10 μg/kg/day by subcutaneous or intravenous. It is recommended that Filgrastim be given for at least 4 days before the first leukapheresis procedure and continued until the last leukapheresis. 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. Filgrastim for 6 to 7 days with leukaphereses on days 5, 6, and 7 is safe and effective.
Patients with Severe Chronic Neutropenia: Daily administration is required to maintain clinical benefit. Absolute neutrophil count should not be used as the sole indication of efficacy. The dose should be individually adjusted based on the patients' clinical course as well as ANC.
The dose ranging from 1.2 μg/kg (idiopathic neutropenia); 2.1 μg/kg (neutropenia cyclic), 6.0 μg/kg (congenital neutropenia) to exceptional cases of congenital neutropenia that required doses greater than 100 μg/kg/day.
Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy: Filgrastim should be administered at 5 μg/kg/day by subcutaneous. The first dose of Filgrastim should be administered at least 24 hours after cytotoxic chemotherapy. The treatment with Filgrastim should be discontinued if the ANC surpasses 100,000/mm3 after the expected chemotherapy-induced neutrophil nadir or for a maximal period of 35 days.
Prophylaxis and Treatment of Neutropenia in Patients with HIV/AIDS: To correct the neutropenia the recommended starting dose of Filgrastim is 5 μg/kg/day to achieve and maintain a normal number of neutrophils (ANC >2.0 x 109/L).
To maintain the neutrophil count within normal limits: Once corrected neutropenia, should determine the minimum effective dose needed to maintain a normal number of neutrophils.
It is recommended to adjust the initial dose to 30 MU (300 μg)/day SC injection on alternate days. Sometimes it may be necessary to further adjust the dose according to the ANC of the patient to keep the number of neutrophils above 2.0 x 109/L.
In the prophylaxis of neutropenia associated with chemotherapy and/or radiotherapy described dosages are recommended for patients with cancer receiving myelosuppressive chemotherapy.
Allowed increases in initial dose of 5 μg/kg to 10 μg/kg in subsequent neutropenic episodes according to the duration and severity of neutropenia above.
Mode of Administration: Administered as a single daily injection by subcutaneous injection or by intravenous infusion.
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