Contraindications
Apidra is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Apidra or any of its excipients.
Warnings and Precautions
Insulin pens and needles must never be shared between patients, even if the needle is changed. Do NOT reuse needles.
Monitor blood glucose in all patients treated with insulin. Modify insulin regimens only under medical supervision. Changes in insulin regimen including, strength, manufacturer, type, injection site or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Dosing should be individualized based on patient characteristics and lifestyle.
Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis may result in hyperglycemia; sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate injection site to unaffected areas and closely monitor for hypoglycemia.
Hypoglycemia is the most common adverse reaction associated with insulins, including Apidra, and maybe life-threatening.
To avoid medication errors between APIDRA and other insulins, instruct patients to always check the insulin label before each injection.
All insulin products, including Apidra, can cause hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including APIDRA. If hypersensitivity reactions occur, discontinue APIDRA, treat per standard of care and monitor until symptoms and signs resolve.
Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs) with insulin. Observe for signs and symptoms of heart failure. Consider dosage reduction or discontinuation of TZD if heart failure occurs.
Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Patients using insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.
Adverse Reactions
Adverse reactions commonly associated with Apidra include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, and weight gain.
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).
Important Safety Information for Apidra (insulin glulisine) injection SoloSTAR
Apidra SoloSTAR is a disposable single-patient-use prefilled insulin pen. To help ensure an accurate dose each time, patients should follow the steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose.
Important Safety Information for Apidra (insulin glulisine) injection Use in Pump
Inform patients to replace the infusion sets (reservoir, tubing, and catheter) and the Apidra in the reservoir at least every 48 hours and select a new infusion site. Pump failure or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Prompt identification and correction of the cause is necessary. Interim subcutaneous injections with APIDRA may be required. Patients using a pump must be trained to administer insulin by injection and have alternative insulin therapy available in case of pump system failure.
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