Important Safety Information for Apidra®
Apidra® is indicated for the treatment of adult patients with diabetes mellitus
for the control of hyperglycemia.
Apidra® has a more rapid onset of action and a shorter duration of action than
regular human insulin. Apidra® should normally be used in regimens that include
a longer-acting insulin or basal insulin analog.
Apidra® may also be infused subcutaneously by external insulin infusion pumps.
OptiClik® is a reusable insulin delivery device (insulin pen) for use with a
3-mL Apidra® cartridge (U-100). Needles and the OptiClik® pen must not be shared.
Apidra® is contraindicated during episodes of hypoglycemia and in patients hypersensitive
to Apidra® or one of its excipients.
Apidra® differs from regular human insulin by its rapid onset of action and shorter
duration of action. 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.
Because of the short duration of action of Apidra®, patients with diabetes also
require a longer-acting insulin or insulin infusion pump therapy to maintain adequate
glucose control.
Any change of insulin should be made cautiously and only under medical supervision.
Changes in insulin strength may result in the need for 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
in different individuals or at different times in the same individual and is dependent
on site of injection, blood supply, temperature, and physical activity.
Glucose monitoring is recommended for all patients with diabetes.
Hypoglycemia is the most common adverse effect of insulin therapy, including Apidra®.
The timing of hypoglycemia may differ among various insulin formulations.
Adverse events commonly associated with human insulin therapy include hypoglycemia,
allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash.
Apidra® should not be mixed with other insulins or with a diluent when used in
the pump.
Pump or infusion set malfunctions or insulin degradation can lead to hyperglycemia
and ketosis in a short time. 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.
To minimize insulin degradation, infusion set occlusion, and loss of the preservative
(mcresol), 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.
Please click here for full prescribing information for Apidra®
