Filgrastim acts by stimulating the growth of neutrophils, a type of white blood cell. Filgrastim specifically promotes proliferation and maturation of neutrophil granulocytes.


Cancer Patients Receiving Myelosuppressive Chemotherapy

The recommended starting dose of filgrastim is 5 mcg/kg/day, administered as a single dally Injection by SC bolus Injection. by short IV infusion (15 to 30 minutes), or by continuous SC or continuous IV Infusion. A CBC and platelet count should be obtained before instituting filgrastim therapy, and monitored twice weekly during therapy. Doses may be increased in increments of 5 mcg/kg for each chemotherapy cycle, according to the duration and severity of the ANC nadir. Fiigrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should not be administered in the period 24 hours before the administration of chemotherapy (see PRECAUTIONS). 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. Filgrastim therapy should be discontinued II the ANC surpasses 10,000/mm3 after the expected chemotherapy-induced neutrophil nadir (see PRECAUTIONS). In phase 3 trials, efficacy was observed at doses of 4 to 8 mcg/kg/day.

Cancer Patients Receiving Bone Marrow Transplant

The recommended dose of filgrastim following BMT is 10 mcg/kg/day given as an IV infusion of 4 or 24 hours, or as a continuous 24- hour SC infusion. For patients receiving BMT, the first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow Infusion.

Peripheral Blood Progenitor Cell CoIlection and Therapy in Cancer patients

The recommended dose of filgrastim for the mobilization of PBPC is 10 mcg/kg/day SC, elther as a bolus of a continuous Infusion. It iIs recommended that filgrastim be given for at least 4 days before the first leukapheresis procedure and continued until the last leukapheresis. Although the optimal duration of filgrastim administration and leukapheresis schedule have not been established, administration of filgrastim for 6 to 7 days with leukaphereses on days 5, 6, and 7 was found to be safe and effective (see CLINICAL STUDIES for schedules used in clinical trials). Neutrophil counts should be monitored after 4 days of filgrastim, and filgrastim dose modification should be considered for those patients who develop a was count > 100,000/mm3. In all clinical trials of filgrastim for the mobilization of PBPC. filgrastim was also administered after reinfusion of the collected cells (see CLINICAl STUDIES).

Patients With Severe Chronic Neutropenia

Filgrastim should be administered to those patients in whom a diagnosis of congenital, cyclic, or idiopathic neutropenia has been definitively confirmed. Other diseases associated with neutropenia should be ruled out.

Starting Dose: Congenital Neutropenia: The recommended daily starting dose is 6 mcg/kg BID SC every day. Idiopathic or Cyclic Neutropenia: The recommended daily starting dose is 5 mcg/kg as a single Injection SC every day.


Cancer,Patients Receiving Myelosuppressive Chemotherapy

filgrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia,in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever . Acomplete blood count (CBC) and platelet count should be obtained prior to chemotherapy, and twice per week during filgrastim therapy to avoid leukocytosis and to monitor the neutrophil count. In phase 3 clinical studies, filgrastim therapy was discontinued when the ANC was > 10,000/mm3 after the expected chemotherapy-induced nadir.

Patients With Acute Myeloid Leukemia Receving Induction or Consolidation Chemotherapy

Filgrastim is indicated for reducing the time to neutrophil recovery and the duration of fever, following Induction or consolidation chemotherapy treatment of adults with AML.

Cancer Patients Receiving Bone Marrow Transplant

Filgrastim is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae, eg, febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation. It is recommended that CBCs and platelet counts be obtained at a minimum of 3 times per week following marrow infusion to monitor the recovery of marrow reconstitution.

Patients Undergoing Peripheral Blood Progenitor CelI CollectiIon and Therapy

Filgrastim is indicated for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. Mobilization allows far the collection of increased numbers of progenitor cells capable of engraftment compared with collection by leukapheresis without mobilization are bone marrow harvest. After myeloablative chemotherapy. the transplantation of an increased number of progenitor cells can lead to more rapid engraftment, which may result in a decreased need for supportive care.

Patients With Chronic Neutropenia

Filgrastim is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg, fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, are idiopathic neutropenia. It is essential that serial CBCs with differential and platelet counts, and an evaluation of bone marrow marphology and karyotype be performed prior to initiation of filgrastim therapy. The use of filgrastim prior to confirmation of SCN may impair diagnostic efforts and may thus Impair or delay evaluation and treatment of an underlying condition, other than SCN, causing the neutropenia.

Product Information

Neumax (Filgrastim 300mcg) - Single dose prefilled syringe of 1 mI


For the use only of a Registered Medical Practitioner or a HospItal or a Laboratory