Important Safety Information for Apidra® (insulin glulisine [rDNA origin] injection)
CONTRAINDICATIONS
Apidra® is contraindicated during episodes of hypoglycemia and in
patients hypersensitive to Apidra® or any of its excipients.
WARNINGS AND PRECAUTIONS
Closely monitor blood glucose in all patients treated with insulin. Change insulin
regimens cautiously and only under medical supervision. Changes in insulin strength,
manufacturer, type, or method of administration may result in the need for a change
in insulin dose or an adjustment in concomitant oral antidiabetic treatment. As
with all insulin preparations, the time course of Apidra® action
may vary by individual or at different times in the same individual and is dependent
on many conditions, including the site of injection, local blood supply, or local
temperature.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Apidra®,
which may be serious.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur.
All insulins, including Apidra®, can cause hypokalemia, which if
untreated, may be serious.
A reduction in the Apidra® dose may be required in patients with
renal or hepatic impairment.
Apidra® for subcutaneous injection should not be mixed with insulins
other than NPH. Do not mix Apidra® with any insulin when used in
the pump or for intravenous administration. Insulin devices and needles must not
be shared between patients.
DRUG INTERACTIONS
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and
close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients
taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and
reserpine).
ADVERSE REACTIONS
Other adverse reactions commonly associated with Apidra® include
injection site reactions, lipodystrophy, pruritus, and rash.
Indications and Usage for Apidra® (insulin glulisine [rDNA origin] injection)
Apidra® is a rapid-acting 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.
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.
Apidra® given by subcutaneous injection should normally be used in
regimens that include a longer-acting insulin.
Please
click here for Full Prescribing Information for Apidra®.
