Dosing & Uses
Acute Myelogenous Leukemia (Investigational/Orphan Status)
Refractory/relapsed AML: 80-90 mg/sq.meter IV on days 1 and 4 (with cytarabine)
Elderly patients with newly diagnosed AML: 72 mg/sq.meter IV x2 doses on days 1 and 8
Ovarian Cancer, Platinum-Resistant (Investigational)
60-75 mg/sq.meter IV q4wk; infuse IV over 5-10 min
Upper GI (mucosal inflammation)
Lower GI (diarrhea/colitis)
Infections (bacterial pneumonia, sepsis, bacteremia, other)
Data limited, unknown
Pregnancy & Lactation
Pregnancy Category: D
Lactation: not known whether distributed in breast milk, do not breast feed
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Metabolism: glucuronide conjugation, oxidation, N-dealkylation, O-dealkylation
Mechanism of Action
Anticancer quinolone derivative; elicits intercalation into DNA and blocks religation of topoisomerase II-induced double-strand breaks at selective sites in DNA, leading to G2 arrest and cell death by apoptosis