Oncology Division
HENPLATIN (Oxaliplatin) HENTAXEL (Docetaxel) TPIAO (Thrombopoietin) ZEFEI (Gemcitabine) ZILONGJIN (Astragalus) HENSETRON (Tropisetron HCl)
Hematology Division
EPOSINO (Epoetin Alfa) FERROFER (Iron Sucrose) TPIAO (Thrombopoietin) WHITE-C (Filgrastim)
Nephrology Division
EPOSINO (Epoetin Alfa) FERROFER (Iron Sucrose)
GoodFellow Pharma Corporation

WHITE-C (Filgrastim)

Solution for Injection
Intravenous, Subcutaneous
Hematopoietic Growth Factor
Drug Name
Filgrastim (Recombinant human granulocyte-colony stimulating factor, G-CSF)

Formulation
Filgrastim ....................................... 300mcg/mL

Inactive Ingredients
HAc-NaAc buffer 10MM, mannitol 5% and Tween-80 0.004%.



General Description
This product is colorless sterile solution with pH 4.0.

rHuG-CSF, by means of genetic engineering technology, has similar bioactivity in vivo as well as in vitro compared with natural human G-CSF.

G-CSF is one of 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.

Storage
Store at 2oC - 8oC

Caution
"Foods, Drugs, Medical Devices and Cosmetics Act prohibits dispensing without Prescription".

Indication
Filgrastim (White C) stimulate.

The production of neutrophili and may reduce the duration of chemotheraphy-induced neutropenia and thereby reduce the incidence of associated sepsis. It is indicated for the reduction in duration of neutropenia and incidence of febrile neutropenia in cytotoxic chemotheraphy for malignancy (except chronic myeloid leukaemia and myelodysplastic syndromes); reduction in the duration of neutropenia (and associated sequelae) in myeloablative theraphy followed by bone-marrow transplantation; mobilization of peripheral blood progenitor cells for harvesting and subsequent autologous 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 and Administration
This product should be administered through subcutaneous or intravenous route 2-3 times per week under physicians' direction. Dosage can be changed according to anemia status, age and other related factors of the patients.

Contra-Indications
Filgrastim (White C) is contraindicated to patients with severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics.

Side-Effects
Side effects of Filgrastim (White C) includes gastro-intestinal disturbances (including nausea, vomiting and diarrhea), anorexia, headache, asthenia, fever, musculoskeletal pain, bone pain, rash, alopecia, injection-site reactions, and leucocytosis. Less frequent side 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.

Dosage and Administration
Cytotoxic-induced neutropenia: Preferably by subcutaneous injection or by intravenous infusion (over 30 minutes). Adult and Child, 500,000 units/kg daily started not less than 24 hours after cytotoxic chemotheraphy, continued until neutrophil count in normal range, usually for up to 14 days (up to 38 days in acute myeloid leukaemia).

Myeloablative theraphy followed by bone-marrow transplantation: By intravenous infusion over 30 minutes or over 24 hours or by subcutaneous infusion over 24 hours, 1 million units/kg daily, started not less than 24 hours following cytotoxic chemotheraphy (and within 24 hours of bone- marrow infusion), then adjusted according to absolute neutrophil count.

Mobilisation of peripheral blood progenitor cells for autologous infusion, used alone: By subcutaneous injection or by subcutaneous infusion over 24 hours, 1 million units/kg daily for 5-7 days; used following adjunctive myelosuppressive chemotheraphy (to improve yield), by subcutaneous injection, 500,000 units/kg daily, started the day after completion of chemotheraphy and continued until neutrophil count in normal range.

Mobilisation of peripheral blood progenitor cells in normal donors for allogeneic infusion: By subcutaneous injection, Adult under 60 years and adolescent over 16 years, 1 million units/kg daily for 4-5 days.

Severe chronic neutropenia: By subcutaneous injection, Adult and Child, in severe congenital neutropenia, initially 1.2 million units/kg daily in single or divided doses (initially 500,000 units/kg daily in idiophatic or cyclic neutropenia), adjusted according to reponse.

Persistent neutropenia in HIV infection: By subcutaneous injection, initially 100,000 units/kg daily, increased as necessary until obsolute neutrophil count in normal range (usual max. 400,000 units/kg daily, then adjusted to maintain absolute neutrophil count in normal range.

Cautions
Filgrastim (White C) should be used with caution in patients with pre-malignant 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.

Use in Pregnancy
Filgrastim (White C) is not recommended in pregnancy or breast-feeding mothers.

Precautions
  • This product should start to use in 24-48 hours after administering the drug during the course of chemotheraphy for tumors
  • During the treatment with Filgrastim (White C), check hemogram for neutral granulocytes twice every one week
  • Be cautious to use Filgrastim (White C) to patients suffering from myeloid proliferation (e.g. Acute Leukemia)


Manufactured By
Shandong Kexing Bioproducts Co., Ltd.
Tangwangshan Road, MingShui Development Zone
ZhangQiu, Jinan-250200, China

Exclusively Imported By
Goodfellow Pharma Corporation
Unit 3009 Jollibee Plaza Bldg., Emerald Ave.,
Ortigas Center, Pasig City
Tel. Nos.: (632) 632-7031
Fax: (632) 635-3957
E-mail: good_fellow88@yahoo.com
Copyright © 2008 Goodfellow Pharma Corporation
Unit 3009 Jollibee Plaza Bldg.,
Emerald Ave., Ortigas Center 1605 Pasig City

Telephone: (+632) 635-3957 / 632-7031
Mobile No.: (0917) 831-1338

e-mail: good_fellow88@yahoo.com