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: J W Smith 2nd
• Journal: Oncology (Williston Park, N.Y.) (Oncology (Williston Park)) Vol. 14 Issue 9 Suppl 8 Pg. 41-7 (Sep 2000) ISSN: 0890-9091 [Print] United States
• PMID: 11033837 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Antineoplastic Agents
• Colony-Stimulating Factors
• Drug Combinations
• Interleukin-11
• Recombinant Proteins
• oprelvekin

Topics

• Antineoplastic Agents (administration & dosage, adverse effects)
• Arrhythmias, Cardiac (chemically induced)
• Blood Platelets (drug effects)
• Colony-Stimulating Factors (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Combinations
• Drug Interactions
• Dyspnea (chemically induced)
• Edema (chemically induced)
• Humans
• Hypokalemia (chemically induced)
• Interleukin-11 (administration & dosage, adverse effects)
• Platelet Activation (drug effects)
• Recombinant Proteins (administration & dosage, adverse effects)
• Safety
• Thrombocytopenia (chemically induced, drug therapy)