Macroleuco

Macroleuco Adverse Reactions

filgrastim

Manufacturer:

Dong-A

Distributor:

Metro Drug

Marketer:

Macropharma Corp
Full Prescribing Info
Adverse Reactions
Peripheral Blood Progenitor Cells Mobilization Donors: Adverse reactions, including abnormalities in laboratory data, to Filgrastim (Macroleuco) were reported in all 51 patients treated. The most frequently observed adverse reactions included lumbar pain in 24 events (47.1%), headache in the 10 events (19.6), arthralgia in 8 events (15.7%), and fever in 6 events (11.8%). The most frequently observed abnormalities in laboratory data included LDH in 44 events (86.3%), increased uric acid in 12 events (23.5%), Thrombocytopenia in 7 events (13.7%), and CRP in 6 events (11.8%).
Neutropenia Patients: Adverse reactions, including abnormalities in laboratory data, to Filgrastim (Macroleuco) were reported in 679 (10.6%) of 6,391 patients treated. The most frequently observed adverse reactions included skeletal pain (chest, lumbar region, pelvis. etc.) in 97 events (1.5%), fever in 73 events (1.1%), lumbar pain 52 events (0.8%), and abnormal hepatic function in 39 events (0.6%). The most frequently observed abnormalities in laboratory data included increased LDH in 222 events (3.5%), increased ALP in 202 events (3.2%) increase ALT (GPT) in 68 events (1.1%), and increased AST (GOT) in 51 events (0.8%).
Shock: Filgrastim (Macroleuco) may cause shock. Adequate monitoring should be made.
Filgrastim (Macroleuco) should be discontinued and appropriate therapy instituted when abnormal symptoms are seen.
Digestive System: Nausea and vomiting may occur at times. Rarely, stomatitis and stomachache may occur.
Respiratory System: As filgrastim may cause the manifestation or exacerbation of interstitial pneumonia, adequate monitoring should be made. Filgrastim should be discontinued and appropriate therapy eg, corticosteroid administration instituted if pyrexia, cough, dyspnea, or abnormality in chest x-ray test occur.
As filgrastim may cause the manifestation of acute respiratory distress syndrome, adequate monitoring should be made. Filgrastim should be discontinued and appropriate therapy eg, breathing care instituted if dyspnea, hypoxia and bilateral obese pulmonary infiltration which rapidly progressed, or abnormality in chest x-ray test occur.
Sore throat and nasal bleeding may rarely occur.
Blood System: In patients with acute myelogenous leukemia and myelodysplastic syndrome, an increase in myeloblasts is observed, administration of the drug should be discontinued. Thrombocytopenia may occur.
Splenic rupture may be accompanied with hypersensitivity (anaphylactic) reaction in peripheral blood progenitor cells mobilization donors. Therefore, the donor should be closely monitored by abdominal ultrasound and hematological succession. If a sudden enlargement of the spleen is observed, filgrastim should be discontinued and appropriate therapy instituted.
Dermatological: Skin disorder (Sweet syndrome, etc) which accompanies neutrophil infiltration painful erythema, fever may occur. Rash, rubor, itch, wheal and skin trouble may rarely occur.
Musculoskeletal System: Ostealgia, lumbago, myalgia may occur at times. Rarely pleurodynia and arthralgia may occur.
Liver: Abnormality in liver and the transient increase in ALT (GOT) and AST (GPT) may occur.
Others: Pyrexia at times (1-5%), increases in LDH, alkaline phosphatase (A1-P). Rarely headache, malaise, palpitation, uric acid and serum creatinine, CRP, splenomegaly, rigidity, asthenia, edema, limbs edema, facial edema, pain, neuropathy may occur.
The following abnormal reactions, which are not presented in this precaution, are newly reported.
Musculoskeletal System: Myalgia (5.8%).
Digestive System: Stomatitis (0.4%), stomachache (0.6%).
Body as a Whole: Rigor (0.9%), asthenia (0.9%), edema (0.3%), limbs edema (0.1%), facial edema (0.1%), pain (0.4%).
Nervous System: Neuropathy (0.1%).
Dermatological: Itch (0.3%), wheal (0.1%), skin trouble (0.1%).
Respiratory System: Nasal bleeding (0.1%), sore throat.
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