Pharmacy Diabetes

Insulin-Formulation-Apidra

Name of Medicine
Insulin glulisine
Presentation
  • Apidra contains 100 IU/mL (3.49 mg/mL) insulin glulisine
Key Practice Points
Therapeutic Indications:
  • 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

Dose:

Apidra is a recombinant human insulin analogue that has been shown to be equipotent to human insulin. It has a more rapid onset and a shorter duration of action than regular human insulin and should be injected within 15 minutes before or immediately after a meal.

  • The dosage of Apidra should be individualised (person centred care). 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. As with all insulins, injection sites within an injection area (abdomen, thigh, deltoid) should be rotated from one injection to the next in order to reduce the risk of lipodystrophy and localised cutaneous amyloidosis.
  • Note: Diabetes MedsCheck with referral to credentialled diabetes educator or member of health care team for support with correct injection technique.
  • As for all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by injection site, exercise, and other variables. Glucose monitoring is recommended for all individuals with diabetes.
  • Note: Diabetes MedsCheck with referral for glucose monitoring and counselling on factors that can impact absorption of insulin.
Mixing of insulins for subcutaneous injection:
  • 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.
Renal impairment:
  • 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.

Liver impairment:
  • 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.

Elderly:

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.

Paediatrics:
  • Apidra can be administered to children ≥4 years of age. Administration to children <4 years has not been studied.
Contraindications:
  • Apidra is contraindicated in patients hypersensitive to insulin glulisine or any of its excipients.
  • Hypoglycaemia
Precautions:
  • Hyperglycaemia – Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and 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 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.
Adverse Effects:
  • 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, dyspnoea, 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 Properties-Summary
Absorption:
Pharmacokinetic profiles in volunteers and people 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.
Distribution:
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.
Excretion:
After subcutaneous administration 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.
More Information

For more detailed information on this product please consult the product information.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=&q=apidra&r=/