IMPORTANT SAFETY INFORMATION FOR APIDRA®
Apidra® is a rapid-acting human insulin analog indicated to improve
glycemic control in adults with type 2 diabetes or adults and children (4 years
and older) with type 1 diabetes. Apidra® is contraindicated during
episodes of hypoglycemia and in patients hypersensitive to Apidra®
or any of its excipients. Apidra® should normally be used in regimens
that include a longer-acting insulin.
OptiClik® is a reusable insulin delivery device for use with a 3-mL
Apidra® cartridge (U-100).
Needles, OptiClik® and cartridge systems must not be shared.
Apidra® may also be infused subcutaneously by external insulin infusion
pumps.
Apidra® has a more rapid onset and shorter duration of action than
regular human insulin. When used as a mealtime insulin, the dose of Apidra®
should be given within 15 minutes before or within 20 minutes after starting a meal.
Glucose monitoring is essential for patients receiving insulin therapy. Any change
in insulin and/or regimen should be made cautiously, only under medical supervision,
and may require a change in dose. Concomitant oral antidiabetic treatment may need
to be adjusted. As with all insulin preparations, the time course of Apidra®
action may vary by individual or at different times in the same individual and depends
on injection site, blood supply, temperature, and level of physical activity.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Apidra®.
The timing of hypoglycemia usually reflects the time-action profile of the administered
insulin formulations. Other adverse events associated with Apidra®
include hypokalemia, allergic reactions, injection site reactions, lipodystrophy,
pruritus, and rash. Less common, but potentially more serious or life-threatening,
is generalized allergy to insulin, including anaphylactic reactions.
Apidra® should not be
mixed with other insulins or with a diluent when used in the pump.
To minimize insulin degradation, infusion set occlusion, and loss of the preservative
(metacresol), the infusion sets (reservoir, tubing, and catheter) and the Apidra®
in the reservoir should be replaced every 48 hours or less, and a new infusion site
should be selected. Pump or infusion set malfunctions or insulin degradation can
quickly lead to hyperglycemia and ketosis. This is especially pertinent for RAI
analogs that are more rapidly absorbed through the skin and have a shorter duration
of action. Prompt identification and correction of the cause of hyperglycemia or
ketosis is necessary. Interim therapy with subcutaneous injection may be required.
Please click here for full prescribing information for Apidra®
