title: Tolerability and side-effect profile of rhIL-11.
abstract: 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]).
authors.affiliation: Clinic Research Earle A. Chiles Research Institute, Providence Portland Medical Center, Oregon, USA. jsmith3@providence.org
authors.forename: J W
authors.initials: JW
authors.lastname: Smith
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001145:Arrhythmias, Cardiac / Q000139:chemically induced; D001792:Blood Platelets / Q000187:drug effects; D003115:Colony-Stimulating Factors / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D004338:Drug Combinations; D004347:Drug Interactions; D004417:Dyspnea / Q000139:chemically induced; D004487:Edema / Q000139:chemically induced; D006801:Humans; D007008:Hypokalemia / Q000139:chemically induced; D017370:Interleukin-11 / Q000008:administration & dosage / Q000009:adverse effects*; D015539:Platelet Activation / Q000187:drug effects; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects*; D012449:Safety; D013921:Thrombocytopenia / Q000139:chemically induced / Q000188:drug therapy
chemical_list: D000970:Antineoplastic Agents; D003115:Colony-Stimulating Factors; D004338:Drug Combinations; D017370:Interleukin-11; D011994:Recombinant Proteins; C105308:oprelvekin