Shandong Kexing


Full Prescribing Info
Filgrastim (recombinant human granulocyte-colony stimulating factor, G-CSF).
White-C contains the following inactive ingredients: Hac-NaAc buffer 10 mM, mannitol 5% and Tween-80 0.004%.
It is a colorless sterile solution with pH 4.
Filgrastim or recombinant human granulocyte-colony stimulating factor (G-CSF), by means of genetic engineering technology, has similar bioactivity in vivo as well as in vitro as compared with natural human G-CSF.
G-CSF is one of the main factors modulating granulocytopoiesis and selectively acts on megakaryocytic progenitors to stimulate its multiplication and differentiation as well as to enhance functions and quantity of neutral granulocytes.
Filgrastim stimulates the production of neutrophil and may reduce the duration of chemotherapy-induced neutropenia and thereby reduce the incidence of associated sepsis.
Reduction in duration of neutropenia and incidence of febrile neutropenia in cytotoxic chemotherapy for malignancy (except chronic myeloid leukemia and myelodysplastic syndromes); reduction in the duration of neutropenia (and associated sequelae) in myeloablative therapy followed by bone marrow transplantation; mobilization of peripheral blood progenitor cells for harvesting and subsequent analogous or allogeneic infusion, severe congenital neutropenia, cyclic neutropenia or idiopathic neutropenia and history of severe or recurrent infections; persistent neutropenia in advanced HIV infection.
Dosage/Direction for Use
Cytotoxic-Induced Neutropenia: Adults and Children: Preferably by SC injection or by IV infusion (over 30 min). 500,000 units/kg daily, started not <24 hrs after cytotoxic chemotherapy, continued until neutrophil count is in normal range, usually for up to 14 days (up to 38 days in acute myeloid leukemia).
Myeloablative Therapy Followed by Bone Marrow Transplantation: 1,000,000 units/kg daily by IV infusion over 30 min or over 24 hrs or by SC infusion over 24 hrs, started not less than 24 hrs following cytotoxic chemotherapy (and within 24 hrs of bone marrow infusion), then adjusted according to absolute neutrophil count.
Mobilization of Peripheral Blood Progenitor Cells for Autologous Infusion: Monotherapy: 1,000,000 units/kg daily for 5-7 days by SC injection or infusion over 24 hrs. Used by following adjunct to myelosuppressive chemotherapy: 500,000 units/kg daily by SC injection (to improve yield), started on the day after completion of chemotherapy and continued until neutrophil count is in normal range.
Mobilization of Peripheral Blood Progenitor Cells in Normal Donors for Allogeneic Infusion: Adults <60 years and Adolescents >16 years: 1,000,000 units/kg daily for 4-5 days by SC injection.
Severe Chronic Neutropenia: Adults and Children: Severe Congenital Neutropenia: Initially, 1.2 million units/kg daily in single or divided doses. Idiopathic or Cyclic Neutropenia: Initially, 500,000 units/kg daily. Doses given by SC injection and adjusted according to response.
Persistent Neutropenia in HIV Infection: Initially, 100,000 units/kg daily by SC injection, increased as necessary until absolute neutrophil count is in normal range. Maximum Dose: Usually, 400,000 units/kg daily, then adjusted to maintain absolute neutrophil count in normal range.
Patients with severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics.
Use in pregnancy & lactation: White-C is not recommended in pregnancy or breastfeeding mothers.
Special Precautions
Patients with premalignant or malignant myeloid conditions. Full blood counts including differential white cell and platelet counts should be monitored. Treatment should be withdrawn in patients who develop signs of pulmonary infiltration. Splenic rupture following administration of granulocyte-colony stimulating factors has been reported; monitor spleen size.
Be cautious in using White-C to patients suffering from myeloid proliferation (eg, acute leukemia).
Use In Pregnancy & Lactation
White-C is not recommended in pregnancy or breastfeeding mothers.
Adverse Reactions
Gastrointestinal disturbances (including nausea, vomiting and diarrhea), anorexia, headache, asthenia, fever, musculoskeletal pain, bone pain, rash, alopecia, injection site reactions and leukocytosis. Less frequent adverse effects include chest pain, hypersensitivity reactions (including anaphylaxis and bronchospasm) and arthralgia. There have been reports of pulmonary infiltrates leading to acute respiratory distress syndrome.
Caution For Usage
White-C should be started 24-48 hrs after the administration of drugs used during the course of chemotherapy for tumors.
During treatment with filgastrim, hemogram should be checked for neutral granulocytes twice every 1 week.
Store at 2-8°C.
Shelf-Life: 24 months.
ATC Classification
L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Inj 300 mcg/mL (vial) x 1 mL, (pre-filled syringe) 300 mcg/mL x 1's.
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