Safety data from two randomized phase II and one abbreviated phase III placebo-controlled, double-blind clinical studies in adult patients with nonmyeloid
malignancies indicate that recombinant human
interleukin-11 (rhIL-11, also known as
oprelvekin [
Neumega]) has an acceptable toxicity profile as
therapy for the mitigation of
chemotherapy-induced
thrombocytopenia. Preliminary data also indicate that
rhIL-11 is well tolerated by pediatric patients with similar types of
cancers. Adverse events associated with
rhIL-11 are generally mild or moderate, reversible with
drug discontinuation, and easily managed. Many of the common adverse events of rhIL-11--including
edema,
dyspnea,
pleural effusions, conjunctival injection, and in some patients, atrial
arrhythmia--occur in association with fluid retention. However, these adverse events can be medically managed and need not limit the use of
rhIL-11, particularly if ameliorative measures, such as
salt restriction and occasional prophylaxis with a
potassium-sparing
diuretic to minimize peripheral
edema, have been instituted along with close monitoring of fluid and
electrolyte status. Such measures are suggested for any patient treated with a
diuretic, especially patients with
cancer who are receiving multiple medications that complicate overall care. Administration of sequential cycles of
rhIL-11 treatment does not appear to result in an increased incidence of adverse events or bone marrow exhaustion.
rhIL-11 does not appear to interact adversely with concomitantly administered chemotherapeutic agents or agents commonly used for supportive care, including
granulocyte colony-stimulating factor (
G-CSF,
filgrastim [Neu-pogen]).