NOVORAPID

What it is

Insulin aspart is an analogue of human insulin, differing by the substitution of the amino acid proline by aspartic acid at position 28 on the B-chain. It is a sterile, clear, colourless, aqueous, ultra-fast acting solution for subcutaneous injection, subcutaneous infusion or intravenous injection. The formulation contains nicotinamide (niacinamide; vitamin B3), which results in a faster initial absorption of insulin, leading to an earlier onset of action and greater early glucose-lowering effect compared to NovoRapid.

Approved indications

— Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Dosing overview

Insulin aspart should be administered 0–2 minutes prior to starting a meal. Administration up to 20 minutes after starting a meal in adults was as efficacious as NovoRapid given before a meal. Dosing is individual and determined in accordance with the needs of the patient, in particular the estimated carbohydrate consumption and glycaemic load of the meal. For injection therapy, insulin aspart should be used in combination with intermediate-acting or long-acting insulin given at least once a day, with approximately 50% of the requirement provided by insulin aspart and the remainder by intermediate acting or long-acting insulin in a basal-bolus treatment regimen. For continuous subcutaneous insulin infusion (CSII), insulin aspart can be used in pumps to cover both the need for bolus insulin (approximately 50%) and basal insulin.

Key safety warnings

Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia, particularly if the insulin dose is too high in relation to the insulin requirement. A consequence of the pharmacodynamics of insulin aspart is that if hypoglycaemia occurs, it may occur earlier after an injection or infusion when compared to other mealtime insulins. The use of inadequate doses or discontinuation of treatment, especially in patients requiring insulin, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis, as there is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. Pump or infusion set malfunctions can lead to a fast onset of hyperglycaemia and ketosis, requiring prompt identification and correction of the cause, and interim therapy with subcutaneous injection may be required. Cases of congestive heart failure have been reported when thiazolidinediones were used in combination with insulin, especially in patients with risk factors for development of congestive heart failure; if the combination is used, patients should be observed for signs and symptoms of congestive heart failure, weight gain and oedema.

Contraindications

Hypersensitivity to the active substance or any of the excipients is a contraindication.

PBS listing

Insulin aspart is listed on the PBS as an injection (human analogue) at 100 units per mL in a 10 mL vial and in cartridges at 100 units per mL in 3 mL packs of 5, with unrestricted restriction type. The ex-manufacturer price for the vial is A$16.33 and for the cartridges is A$28.18 (latest schedule 2026-05-01).

Regulatory history

Insulin aspart was first approved on 27 July 2017. The Pharmaceutical Benefits Scheme Advisory Committee recommended it in November 2018 as an unrestricted benefit listing of a new form, with non-inferiority to NovoRapid and cost-minimisation on a unit for unit basis. Subsequent recommendations were made in July 2020 (extended), November 2021, and July 2023 (extended for an additional 12 months).