Pharmacy Diabetes

Insulin-Formulation-Apidra

Insulin glulisine

  • Apidra contains 100 IU/mL (3.49 mg/mL) insulin glulisine

  • Apidra is indicated for the treatment of type 1 and type 2 diabetes mellitus in adults and children of 4 years or above who require insulin for the management of hyperglycaemia.

For the latest PBS indications please see.

https://www.pbs.gov.au/pbs/search?term=apidra&analyse=false&search-type=medicines

  • Glipizide is often recommended 30 minutes before food to allow its peak action to begin at approximately the same time as the absorption of food. This is not always practical or safe in those that have memory loss. Initial dose is usually 2.5-5mg. Increases in dose should be individualised depending on glucose levels (person centred care) and adjusted with several days in between for stabilisation. Maximum dose of glipizide is 40mg in divided doses with the maximum single dose of 15mg (30mg in two divided doses is often safely given long term). Renal and hepatic dysfunction should have a dose reduction consideration due to the increase risk of hypoglycaemia.
  • Use in Hepatic Impairment - The metabolism and excretion of glipizide may be slowed in those with impaired hepatic function. If hypoglycaemia should occur in such individuals, it may be prolonged and appropriate management should be instituted.
  • Use in Renal Impairment - The metabolism and excretion of glipizide may be slowed in patients with impaired renal function. If hypoglycaemia should occur in such individuals, it may be prolonged and appropriate management should be instituted.

  • Apidra can be mixed with NPH human insulin. If Apidra is mixed with NPH human insulin, Apidra should be drawn into the syringe first. Injection should be made immediately after mixing and should not be administered intravenously.

  • As with all insulins, the requirements for Apidra may be reduced in individuals with renal impairment.

Note: Diabetes MedsCheck with education regarding blood glucose monitoring.

  • In individuals with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. Referral for glucose motoring is recommended.

Note: Diabetes MedsCheck with education regarding this mechanism, blood glucose monitoring.

  • Apidra can be administered to children ≥4 years of age. Administration to children <4 years has not been studied.

As with all insulins, glucose monitoring should be intensified, and dosage adjustment should occur on an individual basis. Hypoglycaemia may be difficult to recognise in the elderly.
Note: Diabetes MedsCheck with education regarding mechanism, blood glucose monitoring.

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

  • Hyperglycaemia - Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis. The first symptoms of hyperglycaemia usually developed gradually, over a period of hours or days. They include nausea, vomiting, drowsiness, flushed dry skin, dry mouth, increased frequency of urination, thirst, and loss of appetite as well as acetone breath. Untreated hyperglycaemic events maybe life threatening.
    Note: Diabetes MedsCheck with referral to healthcare team for sick day management plan and education.
  • There is no data are available on mixing Apidra with insulin preparations other than NPH. Apidra should not be mixed with insulin preparations other than NPH.
  • 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, individuals should be instructed to always check the insulin label before each injection.
    Note: Diabetes MedsCheck with education regarding insulin use.

  • Hypoglycaemia is the most common adverse effect of insulins. As with all insulins, particular caution (including intensified blood glucose monitoring) should be exercised in individuals who are at greater risk of clinically significant sequelae from hypoglycaemic episodes.
    Note: Diabetes MedsCheck with counselling on hypoglycaemia, BG monitoring, side effect profile - counselling that hypoglycaemia is part of side effect profile and if happening regularly, referral to healthcare team for adjustment of dose.
  • Injection site and allergic reactions - As with any insulin therapy, lipodystrophy may occur at the injection site and delay insulin absorption. Other injection site reactions with insulin therapy include redness, pain, itching, hives, swelling and inflammation.
    Note: Diabetes MedsCheck with education regarding side effects. Referral to healthcare team to establish correct injection technique.
  • Insulin antibodies - Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose to correct a tendency to hyper- or hypoglycaemia.
    Note: Diabetes MedsCheck with referral to health care team for education if this seems a possibility.
  • Systemic hypersensitivity reactions may include urticaria, chest tightness, dyspnea, allergic dermatitis and pruritis. Severe cases of generalised allergy, including anaphylactic reaction, may be life-threatening and are uncommon.
    Note: Diabetes MedsCheck with referral to healthcare team if suspected.

Pharmacokinetic profiles in healthy volunteers and patients with diabetes (type 1 or 2) demonstrated that absorption of insulin glulisine was about twice as fast with a peak concentration approximately twice as high compared to regular human insulin.

The distribution of insulin glulisine and regular human after intravenous injections are very similar, with volume of distribution of 13L and 21L and half-lives of 13 and 17 minutes, respectively.

After subcutaneous administration in diabetic and non-diabetic subjects, insulin glulisine is eliminated more rapidly than regular human insulin, with an elimination half-life ranging from 37 to 75 minutes, compared to 86 minutes for regular human insulin.
For more detailed information on this product please consult the product information
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-06058-3&d=202104261016933