Label Changes for:
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin]) injection
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2010
WARNINGS and PRECAUTIONS
- ..NovoLog Mix 70/30 has peak pharmacodynamic activity between 1-4 hours after injection
- NovoLog Mix 70/30 FlexPen is for use by one person only.
- All insulin products, including NovoLog Mix 70/30, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia that, if left untreated, may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (e.g. patients using potassium-lowering medications or patients taking medications sensitive to potassium concentrations).
- all new Clinical Trial Experience, Tables, and Postmarketing Data
- The following are examples of substances that may increase the blood-glucose lowering effect and susceptibility to hypoglycemia: pramlintide
- The following are examples of substances that may reduce the blood-glucose lowering effect: atypical antipsychotics