Alerts
Exenatide (Byetta®) – Altered Kidney Function Reported
November 3, 2009
The FDA announced changes to the product labeling of exenatide, based on post-marketing reports of kidney dysfunction. Alterations in kidney function including acute renal failure (62 cases) and renal insufficiency (16 cases) were reported during the period from April 2005 to October 2008 in patients being treated with exenatide. These adverse events occurred between 3 days and 2 years after starting therapy with exenatide.
Exenatide is an incretin-mimetic agent used in the management of type 2 diabetes mellitus. The new labeling changes have more guidance on use of exenatide in patients with existing kidney dysfunction and worsening kidney function while taking exenatide. Do not use exenatide in patients with a creatinine clearance less than 30 mL/minute (severe renal impairment). Use caution when starting or titrating exenatide in patients who have creatinine clearances between 30 and 50 mL/minute (moderate impairment). Monitor patients for changes in kidney function during exenatide therapy. In the event of worsening renal function unexplained by other factors, consider discontinuing exenatide.
Instruct patients to report any signs or symptoms of kidney dysfunction to their healthcare professionals. Patients should also report nausea, vomiting, or diarrhea as these may lead to dehydration which can be associated with kidney dysfunction. The patient Medication Guide will include information regarding kidney dysfunction.
Additional information can be obtained at the following links:
Medwatch alert – November 2, 2009
Information for Healthcare Professionals – November 2, 2009
The FDA requires the distribution of Medication Guides for drugs determined to be a serious and significant public health concern. With the exception of the erythropoiesis-stimulating agents (ESAs; eg, darbepoetin alfa, epoetin alfa), this requirement applies primarily to medications dispensed in the outpatient setting (refer to Code of Federal Regulations 21CFR208.1) for patient self-administration. When other prescription medications are administered to patients by healthcare professionals (ie, in the hospital, in infusion centers, dialysis centers, clinics, or offices), distributing a Medication Guide is not required, although it may be appropriate to educate patients about the potential hazards of prescription medications, at the clinician’s discretion. When the ESAs are administered to patients by healthcare professionals, a Medication Guide must be distributed when the patient starts therapy, at least once monthly during therapy, and whenever the Medication Guide is substantially updated. The complete list of drugs that require a Medication Guide as part of the FDA-regulated product labeling is available online at: http://www.fda.gov/cder/Offices/ODS/labeling.htm. For more information about the special requirements for ESA Medication Guide, see http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109380.htm.
Updated
November 3, 2009, University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
