FIASP

What it is

Fiasp is an insulin aspart formulation where 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. Fiasp is an insulin aspart formulation in which the addition of nicotinamide (niacinamide; vitamin B3) results in a faster initial absorption of insulin, leading to an earlier onset of action and greater early glucose-lowering effect compared to NovoRapid. Fiasp is a sterile, clear, colourless, aqueous, ultra-fast acting solution for subcutaneous injection, subcutaneous infusion or intravenous injection.

Approved indications

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

Dosing overview

Fiasp should be administered 0–2 minutes prior to starting a meal. Administration of Fiasp up to 20 minutes after starting a meal in adults was as efficacious as NovoRapid given before a meal. Dosing with Fiasp is individual and determined in accordance with the needs of the patient, in particular the estimated carbohydrate consumption and glycaemic load of the meal. Fiasp 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 Fiasp and the remainder by intermediate acting or long-acting insulin in a basal-bolus treatment regimen. Fiasp can be used for continuous subcutaneous insulin infusion (CSII) in pumps, where Fiasp will 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, which may occur if the insulin dose is too high in relation to the insulin requirement. A consequence of the pharmacodynamics of Fiasp is that if hypoglycaemia occurs, it may occur earlier after an injection/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, with 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, and thiazolidinediones should be discontinued if any deterioration in cardiac symptoms occurs.

Contraindications

Fiasp is contraindicated in patients with hypersensitivity to the active substance or any of the excipients listed in section 6.1 List of excipients.

PBS listing

Fiasp is listed on the PBS as injections (human analogue) (fast acting), cartridges, 100 units per mL, 3 mL, 5 with unrestricted access. The ex-manufacturer price is A$28.18.

Regulatory history

Fiasp was first listed on the Australian Register of Therapeutic Goods (ARTG) on 27 July 2017 with three presentations: a 10 mL vial, a 3 mL cartridge (Penfill), and a 3 mL pre-filled pen (FlexTouch). An AusPAR (Australian Public Assessment Report) was published on 11 March 2020 for the indication of treatment of diabetes mellitus in adolescents and children aged 1 year and above. In July 2022, the PBAC recommended continuation of Fiasp for diabetes mellitus, with the recommendation extended for 6 months.