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盐酸托泊替康胶囊说明书(英文).pdf

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盐酸托泊替康胶囊说明书(英文).pdf

上传人:rovend 2021/10/30 文件大小:267 KB

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盐酸托泊替康胶囊说明书(英文).pdf

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文档介绍:HIGHLIGHTS OF PRESCRIBING INFORMATION should be monitored. () Dose may need to be adjusted. ()
These highlights do not include all the information needed to use • Topotecan-induced neutropenia can lead to neutropenic colitis. ()
HYCAMTIN capsules safely and effectively. See full prescribing • Diarrhea, including severe diarrhea requiring hospitalization, has been
information for HYCAMTIN capsules. reported during treatment with HYCAMTIN capsules. () Dose may
need to be adjusted. ()
®
HYCAMTIN (topotecan) Capsules • HYCAMTIN has been associated with reports of interstitial lung
Initial . Approval: 1996 disease, some of which have been fatal. ().
WARNING: BONE MARROW SUPPRESSION • Fetal harm may occur when administered to a pregnant woman.
See full prescribing information for complete boxed warning HYCAMTIN should not be used by pregnant women. ()
HYCAMTIN should be administered only to patients with baseline ------------------------------ ADVERSE REACTIONS -----------------------
neutrophil counts of ≥1,500 cells/mm3 and a platelet count ≥100,000 The most common Grade 3 or 4 hematologic adverse reactions with
cells/mm3. In order to monitor the occurrence of bone marrow HYCAMTIN capsules were neutropenia (61%), anemia (25%), and
suppression, blood cell counts should be monitored (). thrombocytopenia (37%). The most common (≥10%) non-hematologic
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