Leukokine – Filgrastim 300 mcg

Leukokine-1

Leukokine – Filgrastim 300 mcg

Conpositions:

Filgrastim (recombinant human methionyl granulocyte colony-stimulating factor).

Description

Each vial (1.2 mL) contains filgrastim (r-metHuG-CSF) 300 mcg.
It also contains the following excipients: Polysorbate 80 0.048 mg, D-mannitol 60 mg, glacial acetic acid 0.72 mg, sodium hydroxide and water for injection.

Filgrastim is a recombinant human methionyl granulocyte colony-stimulating factor (r-metHuG-CSF) prepared by recombinant deoxyribonucleic acid (DNA) technology. It principally affects the proliferation and differentiation of neutrophils and is used as a hemopoietic agent.

Presentation/Packing

Powder for inj 300 mcg (clear, colorless, odorless or may have a characteristic odor soln) x 1’s.

Indications

Acceleration of an increase in the number of neutrophils following bone marrow transplantation.

Neutropenia caused by cancer chemotherapy: Malignant lymphoma, lung cancer, ovarian cancer, testicular cancer, neuroblastoma and acute leukemia.

Neutropenia accompanying myelodysplastic syndrome and aplastic anemia.

Congenital or idiopathic neutropenia.

Dosage & Administration

Acceleration of an Increase in the Number of Neutrophils Following Bone Marrow Transplantation: Usual Dosage: Adult and Children: 300 mcg/m2 of filgrastim (recombinant) once daily.

Administration should start on between the next day and 5 days after bone marrow transplantation. However, when neutrophil count ≥5000/mm3 (leukocyte 10,000/mm3), administration should be discontinued while monitoring patient’s symptom.
Neutropenia Caused by Cancer Chemotherapy: Solid Cancer: Malignant Lymphoma, Lung Cancer, Ovarian Cancer, Testicular Cancer and Neuroblastoma: Usual DosageAdults and Chidlren: 50 mcg/m2 SC (in adults, 50 mcg/m2 or 75 mcg/body) once daily after termination of cytotoxic chemotheraphy (the next day). To patients in whose case SC injection is not appropriate due to bleeding tendency, etc, 100 mcg/m2  of filgrastim should be administered IV (including IV drip infusion) once daily.
However, administration should be discontinued when nuetrophil count reaches to 5000/mm3(leukocyte 10,000/mm3) after the period in which the least neutrophil count was observed.
Other Cancers: Adults and Children When Fever (in principle, lot <38) with Neutrophil Count of <1000/mm3 by Chemotherapy or Neutrophil Count of <500/mm3 are Observed: Usual Dosage: 50 mcg/mSC use.

To patients in whose case SC injection is not appropriate due to a bleeding tendency, etc, 100 mcg/mof filgrastim should be administered IV (including IV drip infusion) once daily.
50 mcg/m2 of filgrastim (recombinant) is administered once daily, in SC, when neutropil count of <1000/mm3 is observed, to patients whose case have had fever (in principle, lot <38) with neutrophil count of <1000/mm3 by chemotherapy or neutrophil count <500/mm3, have treated chemotherapy continuously, and since then receive same chemotherapy. To patients, in whose case SC injection is not appropriate due to a bleeding tendency, etc, 100 mcg/m2 should administered IV (including IV drip infusion) once daily.
However, administration should be discontinued when neutrophil count reaches to 5000/mm3 after the period in which the least neutrophil count was observed. On the other hand, neutrophil count is estimated as the half of white blood cell count, when it occurs that neutrophil count cannot be indentified such as emergency and so on.

Acute Leukemia: Adults and Children Who Have No Myeloblasts in the Peripheral Blood Resulting From the Sufficient Decrease of Blasts in Bone Marrow After the Termination of Cytotoxic Chemotherapy (the next day): 200 mcg/monce daily given by IV bolus and/or infusion. In case no symptoms such as bleedings, Filgrastim is administered in a dosage of 100 mcg/m2 once daily given by SC.

However, administration should be discontinued when neutrophil count reaches to 5000/mm3 after the period in which the least neutrophil count was observed.

Neutropenia Accompanying Myelodysplastic Syndrome: Adult With a Neutrophil Count of <1000/mm3: Usual Dosage: 100 mcg/m2 once daily for IV drip infusion; Neutrophil Count ≥5000/mm3The dosage should be reduced or administration should be discontinued while monitoring patient’s symptom.

Neutropenia Accompanying Aplastic Anemia: Adults and Children With a Neutrophil Count <1000/mm3Usual Dosage: 400 mcg/m2 once daily for IV drip infusion. Neutrophil Count <1000/mm3The dosage should be reduced or administration should be discontinued while monitoring patient’s symptom.

Congenital or Idiophatic Neutropenia: Adults and Children With a Neutrophil Count of <1000/mm3:Usual Dosage: 50 mcg/m2 once daily for IV drip infusion; Neutrophil Count ≥5000/mm3The dosage should be reduced or administration should be discontinued while monitoring patient’s symptom.

In above cases, the dosages may be adjusted according to the patient’s age and symptoms.

Contraindications

Known hypersensitivity to filgrastim or to other G-CSF products.

Patients with myeloid leukemia whose blasts are not decreased sufficiently.

Warnings

Leukokine should be administered with caution to patients with known history of hypersensitivity or allergic reactions to drugs.

Special Precautions

Leukokine should be administered only for the treatment of neutropenia.
During the therapy, regular hematological monitoring should be performed and full observation should be taken to avoid excessive leukocytosis.

As the possibility of hypersensitivity (eg, anaphylaxis) cannot be excluded, full observation should be taken. If the symptoms appear, Leukokine therapy should be discontinued and an appropriate treatment should be taken. In order to avoid occurring hypersensitivity reaction, it is recommended to perform skin reaction test and investigate any history of before initiating the therapy:

Leukokine should not be used before initiating antineoplastic therapy: It should be used after the administration of antineoplastic agents.

It is reported that osteomyelodysplasia accompanying increase of blasts is transferred to myeloid leukemia and thus an appropriate in vitro test on the collected cells to see any increase of blast colony is required.

Before administration to patients with acute myeloid leukemia who receiving chemotherapy or bone marrow infusion, perform an appropriate in vitro test to see if the leukemic cells are increased by Leukokine. Periodic hematologic and bone marrow analysis should be followed and the therapy is discontinued when an increase of blast is observed.
Special caution with full observation should be taken when Leukokine is administered to pediatric patients.

Others: In animal tests, filgrastim has been reported to be antigenic.

Use in pregnancy: As the safety of filgrastim in pregnancy has not been established, it is not recommended to administer Leukokine to pregnant women or possible women to be pregnant. Filgrastim should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

Use in children: As the safety and efficacy of filgrastim in immature neonates, neonates or infants have not been fully established, administration in infancy is not recommended. (Only limited data is available.)

Use in the elderly: As general physiological function is reduced in geriatric patients, filgrastim should be used with special caution in dose or frequency of administration and full observation should be taken.

Adverse Drug Reactions

Shock: As shock may occur, full observation should be taken. If the symptoms appear, the administration should be discontinued and an appropriate treatment should be taken.

Dermatologic: Rash and ruber have been reported occasionally.

Hepatic: Elevation of glutamate-oxaloacetic transaminase (GOT) and glutamic-oxaloacetic transaminase (GPT) has been reported occasionally.

Gastrointestinal: Adverse gastrointestinal effects including nausea and vomiting have been reported occasionally.

Musculoskeletal Effects: Skeletal pain, lumbago, chest pain or arthralgia may occur occasionally.

Acute Respiratory Distress Syndrome: As acute respiratory distress syndrome has been reported, full observation should be taken. If impetuous dyspnea, hypoxia or radiographic abnormalities (eg, adiopogenic infiltration of both lungs) is observed, the administration of Leukokine should be discontinued and an appropriate treatment should be applied.

Pregnancy Category (US FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Caution For Usage

Instructions for Use and Handling: Leukokine is diluted in dextrose 5% or saline for IV infusion in use.

Leukokine should not be administered concomitantly with other drugs in use.
Prior to cutting the ampoule, it is advisable to disinfect the surface of cutting area with alcohol.

Storage

Leukokine injection should be stored in refrigerator below 10°C.
Shelf-Life: 24 months.

Manufacturered by: CJ Corp.

Head office

500, 5-Ga, Namdaemun-No, Chung-Ku, Seoul, Korea

Tel : (02 726-8415∼18 Fax : (02) 726-8428

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