Cancer Patients Receiving Myelosuppressive Chemotherapy: The recommended starting dose of FILGRASTIM (LEUCOGEN) is 5 mcg/kg/day, administered as a single daily injection by SC bolus injection. A complete blood count and platelet count should be obtained before instituting FILGRASTIM (LEUCOGEN) therapy, and monitored twice weekly during therapy. Doses may be increased in increments or 5 mcg/kg for each chemotherapy cycle, according to the duration and severity of the absolute neutrophil count nadir. FILGRASTIM (LEUCOGEN) 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 (LEUCOGEN) therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed. FILGRASTIM (LEUCOGEN) 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 (LEUCOGEN) following bone marrow transplant is 10 mcg/kg/day given as an IV infusion or 4 or 24 hours. The first dose of FILGRASTIM (LEUCOGEN) 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 (LEUCOGEN) should be titrated against the neutrophil response as follows: When ANC >1000/mm3 for 3 consecutive days the FILGRASTIM (LEUCOGEN) dose should be reduced to 5 mcg/kg/day. If ANC remains >1000/mm3 for 3 more consecutive days after the dose reduction, the treatment with FILGRASTIM (LEUCOGEN should be discontinued. If ANC decreases to <1000/mm3 the treatment should be resumed at 5 mcg/kg/day. If ANC decreases to <1000/mm3 at any time during the 5 mcg/kg/day administration, FILGRASTIM (LEUCOGEN) should be increased to 10 mcg/kg/day, and the above steps should then be followed. The treatment should be administered for 14 days.
Peripheral Blood Progenitor Cell Collection and Therapy In Cancer Patients: The recommended dose of FILGRASTIM (LEUCOGEN) for the mobilization of PBPC is 10 mcg/kg/day SC. It is recommended that FILGRASTIM (LEUCOGEN) 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 (LEUCOGEN) and FILGRASTIM (LEUCOGEN) dose modification should be considered for those patients who develop a WBC count >100,000/mm3. FILGRASTIM (LEUCOGEN) for 6 to 7 days with leukapheresis on days 5, 6 and 7 is safe and effective.
Patients With Severe Chronic Neutropenia: Chronic 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 median daily doses are: 6.0 mcg/kg (congenital neutropenia), 2.1 mcg/kg (cyclic neutropenia), and 1.2 mcg/kg (idiopathic neutropenia). In rare instances, patients with congenital neutropenia have required doses >100 mcg/kg/day.
Patients With Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy: FILGRASTIM (LEUCOGEN) should be administered at 5 mcg/kg/day given as subcutaneous bolus. The first dose or FILGRASTIM (LEUCOGEN) should be administered at least 24 hours after cytotoxic chemotherapy. FILGRASTIM (LEUCOGEN) therapy should be discontinued if the ANC surpasses 10,000/mm3 after the expected chemotherapy-induced neutrophil nadir or for a maximal period of 35 days.