Macroleuco

Macroleuco Special Precautions

filgrastim

Manufacturer:

Dong-A

Distributor:

Metro Drug

Marketer:

Macropharma Corp
Full Prescribing Info
Special Precautions
Periodic blood tests should be performed during the period of treatment with Filgrastim (Macroleuco) in order to prevent an excessive increase in neutrophils (WBC).
Anaphylaxis, etc may occur. If such reactions are observed, administration should be discontinued immediately and appropriate therapy instituted. To assess the risk of hypersensitivity, a careful interview of the patient and a skin reaction test is recommended before administration.
Skeletal pain and lumbar pain, etc may occur after administration of Filgrastim (Macroleuco). If such symptoms are observed, a non-narcotic analgesic should be administered or other appropriate therapeutic measures should be taken. In cases of peripheral blood progenitor cells mobilization donors, a non-narcotic analgesic should be administered or other appropriate therapeutic measures should be taken because there is a high incidence of skeletal pain and lumbar pain, etc after administration of Filgrastim (Macroleuco). Since transient thrombocytopenia, etc associated with the harvesting of peripheral blood progenitor cells may occur, anti-thrombotic drugs eg, aspirin should be used with caution.
The caution for the increased palpation of neutrophil when transplantation of hematopoietic stem cells and neutropenia caused by cancer chemotherapy.
1) For patients with neutropenia caused by cancer chemotherapy, administration of Filgrastim (Macroleuco) should be avoided 24 hours before and 24 hours after cancer chemotherapy.
2) In patients with acute myeloid leukemia (in case of cancer chemotherapy or transplantation of hematopoietic stem cell), the reaction of increase in leukemic cell responding to Filgrastim (Macroleuco) should be confirmed in vitro prior to Filgrastim (Macroleuco) treatment.
The caution for the administration to neutropenia, which is accompanied with myelodysplastic syndrome. It is known that myelodysplastic syndrome accompanied by an increase in myeloblasts may develop into myelogenous leukemia. Therefore, it is recommended to confirm in vitro before administration that there is no evidence of an increase in blast colony formation in collected cells.
For patients with acute myelogenous leukemia (treated with cancer chemotherapy and bone marrow transplantation), it is recommended to confirm before administration whether Filgrastim (Macroleuco) stimulates the proliferation of leukemia cells by conducting an in vitro study using collected cells. Periodic blood tests and bone marrow tests should be performed, and if an increase in myeloblasts is observed, administration of Filgrastim (Macroleuco) should be discontinued.
The caution for the administration to neutropenia conflicting with the treatment of HIV infections. For patients with neutropenia conflicting with the treatment of HIV infections, the treatment period is set at 2 weeks and should not exceed 6 weeks even when continued therapy is required (the safety of Filgrastim (Macroleuco) with a treatment period longer than 6 weeks has not been established). The product should be administered with care while closely monitoring the patient's condition to prevent an excessive increase in neutrophils (granulocyte precursor cells may be decreased and the responsiveness to Filgrastim (Macroleuco) may be reduced). In cases in which no increase in neutrophil count is observed after the administration of the product for 1 week or longer, administration should be discontinued and appropriate therapy instituted. Since a possibility of HIV proliferation upon treatment with Filgrastim (Macroleuco) cannot be ruled out, the primary disease should be carefully monitored.
The safety and efficacy have not been evaluated in patients receiving concurrent radiation therapy.
Precautions regarding mobilization of hematopoietic progenitor cells to peripheral blood: 1) In the event that peripheral blood progenitor cells are mobilized from donor, it is recommended to perform properly with reference to the related guidelines. As general malaise, limbs edema, vasovagal reflex, etc are accompanied with peripheral blood progenitor cells mobilization, the change of general condition such as blood pressure should be monitored.
2) In the event the Filgrastim (Macroleuco) is used in donors, the informed consent of the donor or, if incapable of giving consent, the donor's representative, should be obtained prior to administration after fully explaining that the long-term safety of Filgrastim (Macroleuco) has not been established and that scientific data is currently being collected.
3) Clinical experience of Filgrastim (Macroleuco) in donors is limited. Filgrastim (Macroleuco) should be administered with care while closely monitoring the condition of the donor after taking donor's general condition into consideration.
4) In the event that Filgrastim (Macroleuco) is used in donors, it should be confirmed beforehand that the donor is negative to all of the following tests in order to avoid the transmission of infections to the recipient: HBs antigen, HBc antibody, HCV antibody, HIV-1, -2 and HTLV-I antibodies and serological tests for syphilis. Serological tests for CMV and herpes should also be performed.
5) Splenic rupture may occur because of anaphylaxis when administered with Filgrastim (Macroleuco).
6) In the event that Filgrastim (Macroleuco) is used to harvest hematopoietic progenitor cells from autologous peripheral blood progenitor cells following the completion of cancer chemotherapy, the harvest of peripheral blood progenitor cells should be commenced in the recovery period when the WBC increased to 5000 to 10,000 mm3 after the lowest WBC is observed.
7) Filgrastim (Macroleuco) must be administered with caution because thrombocytopenia may occur after administration of Filgrastim (Macroleuco) and following the harvest of peripheral blood progenitor cells.
8) Filgrastim (Macroleuco) must be administered with caution because leukopenia (neutropenia) may occur 1 to 2 weeks after the harvest of peripheral blood progenitor cells.
Precautions in Use: Filgrastim (Macroleuco should not be administered with the other injection(s) together. When the product is administered intravenously, the injection rate should be as low as possible. Do not shake.
Other Precautions: It has been reported that aplastic anemia and congenital neutropenia in patients treated with G-CSF preparations developed into myelodysplastic syndrome or acute myelogenous leukemia.
It has been reported that chromosomal aberration was observed in patients with aplastic anemia, myelodysplastic syndrome and congenital neutropenia following treatment with G-CSF preparations.
It has been reported that myeloproliferative disease or acute myeloid leukemia are developed in the peripheral blood progenitor cells mobilization donors treated with G-CSF.
It has been reported that G-CSF preparations showed a facilitatory effect on proliferation of several strains of human bladder cancer and osteosarcoma in vitro or in vivo.
In addition to the adverse events with the use of filgrastim, temporary cardiac arrest has been reported following the harvest of peripheral blood progenitor cells in peripheral blood progenitor cell mobilization donors treated with G-CSF preparation. However, the relationship with Filgrastim (Macroleuco) is indefinite. Cardiac failure, vasculitis, cerebrovascular disorder, migraine, diarrhea, deafness, mediterranean thalassemia, sickle cell crisis, gout, hyperglycemia, cartilage disorder, ischemic heart disease, myocarditis, amenorrhea, pulmonary hemorrhage and renal carcinoma have been reported as adverse events.
It has been reported that autologous peripheral blood progenitor cells harvested from patients with breast cancer, malignant lymphoma, or myeloma are contaminated with tumor cells.
Use in children: The safety of Filgrastim (Macroleuco) in premature infants, neonates and infants has not been established. Therefore, use of Filgrastim (Macroleuco) is not recommended (insufficient clinical data).
In the event of pediatric use, Filgrastim (Macroleuco) should be administered with care while closely monitoring the condition of the patients. Clinical experience of Filgrastim (Macroleuco) in pediatric peripheral blood progenitor cells mobilization donors, in particular, is limited. Therefore, Filgrastim (Macroleuco) should be administered with care while closely monitoring the condition of the donor after taking the donor's general condition into consideration.
Use in the elderly: Elderly people generally have weakened physiologic functions eg, the function of hematopoiesis, liver and kidney. Special care should be taken in dosage and administration interval according to each patient's condition.
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