Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5. WARNINGS AND PRECAUTIONS
5.5 Effect on QT/QTc Interval
- Androgen deprivation therapy may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.
5.3 Hyperglycemia and Diabetes
- Hyperglycemia and an increased risk of developing diabetes have been reported in men patients receiving GnRH agonists. Hyperglycemia may represent development of diabetes mellitus or worsening of glycemic control in patients with diabetes. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH agonist and manage with current practice for treatment of hyperglycemia or diabetes.
5.4 Cardiovascular Diseases
- Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice.
USE IN SPECIFIC POPULATIONS
- Eligard is not indicated for use in women. It is not known if leuprolide acetate is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Eligard, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.