Apidra (insulin glulisine) - Sanofi Canada

Accidental mix-ups between insulin glulisine and other insulins, particularly long-acting insulins,
have been reported. To avoid medication errors between insulin glulisine and other insulins,
patients should be instructed to always check the insulin label before each injection (see
ADVERSE REACTIONS).
Endocrine and Metabolism
Hypoglycemia:
As with all insulin preparations, hypoglycemic reactions may be associated with the
administration of APIDRA. Hypoglycemia is the most common adverse effect of insulin therapy,
including APIDRA (see ADVERSE REACTIONS). Hypoglycemia may occur if the insulin dose
is too high in relation to the insulin requirement (see OVERDOSAGE). Use caution in patients
with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g.,
the pediatric population and patients who fast or have erratic food intake). Early warning
symptoms of hypoglycemia may be different, be less pronounced or absent, under certain
conditions, as for example if glycemic control is markedly improved, if hypoglycemia is
developing gradually, in elderly patients, in patients with a long history of diabetes, in patients
with diabetic nerve disease, in patients using some medications such as beta-blockers, or
intensified diabetes control (see DRUG INTERACTIONS). Such situations may result in severe
hypoglycemia (and possibly, loss of consciousness) prior to patients’ awareness of
hypoglycemia.
Severe hypoglycemia may require the assistance of another person. Patients who are unable to
take sugar orally or who are unconscious may require an intramuscular/subcutaneous injection of
glucagon or should be treated with intravenous administration of glucose by medical personnel.
Without immediate medical help, serious reactions or even death could occur.
The time of occurrence of hypoglycemia depends on the action profile of the insulins used and
may, therefore, change when treatment regimen is changed.
As with all insulins, prolonged or severe hypoglycemic attacks, especially if recurrent, may lead
to neurological damage, loss of consciousness, coma or death (see ADVERSE REACTIONS).
Hypoglycemic reactions following treatment with insulin products such as APIDRA are mostly
mild and easily managed. Changes in insulin therapy or changes in life style (i.e. diet, omission
of a meal, exercise/ physical activity) may require a change in dosage to avoid hypoglycemia.
Glucose monitoring is recommended for all patients with diabetes.
Diabetic patients should be instructed to carry a few lumps of sugar, candies or biscuits to
prevent the progression of a hypoglycemic reaction, should one occur (see PART III:
CONSUMER INFORMATION).
Page 6 of 61