Apidra (insulin glulisine) - Sanofi Canada

Antibody Production:
Insulin administration may cause insulin antibodies to form. Insulin antibodies are frequently
cross-reactive. Insulin administration may cause the insulin antibodies to form. Insulin antibodies
are frequently cross-reactive. In clinical studies, cross-reactive antibodies were observed in both
insulin glulisine and comparator (insulin lispro, regular human insulin) treatment groups with
similar percents of increased and decreased titers. There was no correlation between crossreactive
insulin antibody concentration and changes in A1c, insulin doses, or incidence of
hypoglycemia and the clinical significance of these antibodies is not clear. In theory, the
presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to
correct a tendency to hyperglycemia or hypoglycemia but has not been found on review of
APIDRA clinical trials.
Intercurrent conditions
Insulin requirements may be altered during illness, emotional disturbances or stress.
Insulin pumps
When used in an external insulin pump for subcutaneous infusion, APIDRA should not be mixed
with any other insulin or diluted with any other solution. Patients using external pump infusion
therapy should be trained appropriately. Physicians and patients should carefully evaluate
information on pump use in the APIDRA product monograph, package insert, and the pump
manufacturer’s manual.
APIDRA specific information should be followed for period of use, frequency of changing
infusion sets, or other details specific to APIDRA usage, because APIDRA specific information
may differ from general or other insulin’s pump manual instructions. Pump or infusion set
malfunctions or insulin degradation can lead to hyperglycemia and ketosis in a short time. This is
especially pertinent for rapid-acting insulin analogues that are more rapidly absorbed 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 (see DOSAGE
AND ADMINISTRATION, Continuous Subcutaneous Insulin Infusion Pump, CONSUMER
INFORMATION, Vials, Continuous Subcutaneous Insulin Infusion Pump, STORAGE AND
STABILITY).
Renal / Hepatic / Biliary / Pancreatic impairment
The pharmacokinetic properties of APIDRA were generally maintained in subjects with renal
impairment. Studies have not been performed in patients with hepatic impairment. As with all
insulins, APIDRA requirements may be diminished due to reduced capacity for gluconeogenesis
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