- Men and women must be 18 to 65 years of age, with nonmyeloid malignancies for whom
oprelvekin is indicated.
- At least one documented occasion of adequate hematologic recovery from previous or
- Adequate renal and hepatic excretory function.
- A marked baseline prolongation of QT/QTc interval (eg, repeated [two out of three
readings] demonstration of a QTcF interval >450 msec.
- Additional risk factors for torsades de pointes including heart failure (subjects
that have functional class III or IV congestive heart failure), hypokalemia,
hypomagnesemia, or hypocalcemia.
- A pace maker or defibrillator.
- A history of LQTS, syncope, seizure, or the unexplained cardiac-related death of a
family member at less than 30 years of age.
- Requirement of concomitant prescription or non-prescription medications or dietary
supplements that have a risk of causing torsades de pointes or prolonged QT/QTc