APIDRA

What it is

Apidra contains 100 IU/mL insulin glulisine. Apidra is a sterile clear, colourless solution of insulin glulisine in vials and cartridges for use as an injection. Apidra is a recombinant human insulin analogue that has been shown to be equipotent to human insulin. After subcutaneous administration it has a more rapid onset and a shorter duration of action than regular human insulin.

Approved indications

— Type 1 and type 2 diabetes mellitus in adults and children of 4 years or above who require insulin for the control of hyperglycaemia.

Dosing overview

The dosage of Apidra should be individualised and determined based on the physician's advice in accordance with the needs of the patient. Apidra should be given by injection within 15 minutes before or immediately after a meal. Apidra should normally be used in regimens that include a longer-acting insulin or basal insulin analogue. Apidra should be administered by subcutaneous injection in the abdominal wall, the thigh or deltoid.

Key safety warnings

Hypoglycaemia is the most common adverse effect of insulins and may occur if the insulin dose is too high in relation to the insulin requirement. The warning symptoms of hypoglycaemia may be changed, less pronounced or absent in certain risk groups, including patients whose glycaemic control is markedly improved, elderly patients, those with autonomic neuropathy, patients with a long history of diabetes, and patients receiving concurrent treatment with certain drugs. Such situations may result in severe hypoglycaemia and possibly loss of consciousness prior to the patient's awareness of hypoglycaemia. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and localised cutaneous amyloidosis, as there is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Medication errors have been reported in which other insulins, particularly long-acting insulins, have been accidentally administered instead of insulin glulisine. Patients should be instructed to always check the insulin label before each injection to avoid medication errors between insulin glulisine and other insulins. Systemic allergic reactions to insulin may be associated with rash, shortness of breath, wheezing, reduction in blood pressure, rapid pulse or sweating, and severe cases of generalised allergy, including anaphylactic reaction, may be life-threatening.

Contraindications

Apidra is contraindicated in patients hypersensitive to insulin glulisine or any of its excipients.

PBS listing

Apidra cartridges (100 units per mL, 3 mL, 5 pack) are listed on the PBS with 2 items at an unrestricted restriction level and ex-manufacturer price of A$28.19. The injection vial formulation (100 units per mL, 10 mL) is listed with 1 PBS item at an unrestricted restriction level and ex-manufacturer price of A$16.33.

Regulatory history

Apidra insulin glulisine 100 IU/mL vials and cartridges were first listed on the ARTG on 2 May 2005. The Apidra SoloStar pre-filled injection pen was first listed on the ARTG on 28 November 2006. Apidra was first approved on 25 May 2009.