Safety Profile for Apidra®, a Rapid-Acting Insulin
Apidra® offers safety comparable to other
rapid-acting and short-acting insulins
- Apidra® has a safety profile similar to other rapid-acting insulin analogs and RHI, whether administered premeal or immediately postmeal1,2
- Hypoglycemia* rates with Apidra® and lispro were comparable2
Consistency among many patient types
- Subgroup analyses show no differences in safety of Apidra® in subgroups defined by demographics (age, sex, race)1
Low intrapatient variability
- The reproducibility of pharmacodynamics is similar to lispro and RHI1
- — Ensures predictability of glucodynamic response in type 1 and type 2 patients
*Hypoglycemia requiring intervention from a third party.
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.
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.
Please click here for full prescribing information for Apidra®
