Pharmacy Diabetes

Insulin-Formulation_Fiasp

Insulin aspart (rys)

  • 1 mL of the solution contains 100 units of insulin aspart (equivalent to 3.5 mg).
  • FlexTouch: 1 pre-filled pen contains 3 mL
  • Vial: 1 vial contains 10 mL
  • Penfill: 1 cartridge contains 3 mL

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

For the latest PBS indications for Fiasp please see
https://www.pbs.gov.au/medicine/item/11706D

  • 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.
  • Fiasp can be used for some continuous subcutaneous insulin infusion (CSII) in pumps or be administrated intravenously by healthcare professionals.
    Note: For further information see section headed consultation notes.
  • The potency of insulin analogues, including Fiasp, is expressed in units. One (1) unit of Fiasp corresponds to 1 international unit of human insulin or 1 unit of other fast-acting insulin analogues.
  • Dosing with Fiasp is individual and determined in accordance with the needs of the individual, in particular the estimated carbohydrate consumption and glycaemic load of the meal.
  • Fiasp comes in a prefilled pen (FlexTouch). Fiasp FlexTouch delivers 1-80 units in steps of 1 unit. Fiasp FlexTouch is colour-coded and accompanied by a package leaflet with detailed instructions for use to be followed. Add picture
  • Fiasp comes in a vial to be used with insulin syringes with the corresponding unit scale (U100 or 100 U/mL).
  • Fiasp comes in a cartridge (Penfill) designed to be used with Novo Nordisk insulin delivery systems (NovoPen®) (not PBS listed at the time of writing) and not available
  • Penfill/FlexTouch: Needles and Fiasp Penfill/Fiasp FlexTouch must not be shared. Thecartridge must not be refilled.
  • Fiasp must not be used if the solution does not appear clear and colourless.
  • Fiasp which has been frozen must not be used.
  • Needles should be discarded after each injection.
  • Fiasp is administered subcutaneously in the abdominal wall, the upper arm, or the thigh. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy and cutaneous amyloidosis.
    Note: Diabetes MedsCheck with referral to healthcare team for education on injection technique and managing hypoglycaemia.
  • The duration of action of Fiasp may vary according to the dose, injection site, blood flow, temperature, and level of physical activity.
  • Use in renal impairment: Fiasp can be used in renal impairment. As with all insulins, glucose monitoring should be intensified, and dosage adjustment should occur on an individual basis.
  • Use in liver impairment: Fiasp can be used in hepatic impairment. As with all insulins, glucose monitoring should be intensified, and dosage adjustment should occur on an individual basis.

  • The safety and efficacy of Fiasp have been established in the elderly. Close glucose monitoring is recommended, and the insulin dose should be adjusted on an individual basis.

  • There is no clinical experience with the use of Fiasp in children below the age of 2 years.

  • Hypersensitivity to the active substance or any of the excipients

  • Hypoglycaemia: 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 side effect profile Hypoglycaemia is part of the side effect profile and if happening regularly consider referral to healthcare team for adjustment of dose. Referral for blood glucose monitoring and support in managing hypoglycaemia. Regular blood glucose monitoring is essential in individuals on intensive insulin therapy and when there is a change in insulin type or dose.
  • The fast onset of action should be considered in individuals with delayed gastric emptying.
  • Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland may require changes in the insulin dose.
  • Paediatric population: Closer monitoring of blood glucose levels in the evening and before bedtime is recommended if administering this medicine after the start of the last meal of the day, to avoid nocturnal hypoglycaemia.
    Note: Diabetes MedsCheck with counselling on side effect profile Hypoglycaemia is part of the side effect profile and if happening regularly consider referral to healthcare team for adjustment of dose. Referral for blood glucose monitoring and support in managing 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.

  • Hypoglycaemia: 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 side effect profile. Hypoglycaemia is part of the side effect profile and if happening regularly consider referral to healthcare team for adjustment of dose. Referral for blood glucose monitoring and support in managing hypoglycaemia.
  • 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. With Fiasp generalised hypersensitivity reactions (manifested by generalised skin rash and facial oedema) was reported uncommonly (0.2% vs. 0.3% for comparator). Based on post marketing data, serious forms of systemic allergic reactions may occur. Immediate type allergic reactions to either insulin itself or the excipients may potentially be life-threatening. Note: Diabetes MedsCheck with counselling on side effect profile and referral to healthcare team to establish correct injection technique.
  • Skin and subcutaneous tissue disorders: Individuals must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic management 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. Note: Diabetes MedsCheck with referral to healthcare team for correct injection technique and managing hypoglycaemia.

  • Absorption: Human insulin molecules self-associate to form hexamers. The substitution of proline by aspartic acid at position B28 in insulin aspart produces an intermolecular repulsion which reduces the tendency of the insulin molecules to self-associate. The inclusion of nicotinamide in the Fiasp formulation further reduces self-association. This increases the rate of dissociation of hexamers into dimers and monomers in the subcutaneous layer. This results in a faster initial absorption of insulin, leading to an earlier onset of exposure and greater early insulin exposure following bolus administration via subcutaneous injection or through CSII in pumps compared to NovoRapid.
    After administration of Fiasp, insulin appeared in the circulation approximately 4 minutes after administration (Figure 3). The onset of appearance was twice as fast (corresponding to 5 minutes earlier), time to 50% maximum concentration was 9 minutes shorter with Fiasp compared to NovoRapid with four times as much insulin available during first 15 minutes and with twice as much insulin available during the first 30 minutes. The total insulin exposure (AUCinsulin aspart, 0-12hours) and the maximum insulin concentration (Cmax) were comparable between Fiasp and NovoRapid. Total exposure and maximum insulin concentration increase proportionally with increasing subcutaneous dose of Fiasp within the therapeutic dose range.
    The pharmacokinetic profiles of Fiasp and NovoRapid are distinct during the first hour following administration which is of particular importance for a mealtime insulin. The earlier onset of action of Fiasp and the subsequent increased glucose lowering effect compared with NovoRapid must be considered when prescribing Fiasp.
  • Distribution: Insulin aspart has a low binding affinity to plasma proteins (<10%), similar to that seen with regular human insulin.
  • Metabolism: Degradation of insulin aspart is similar to that of human insulin.
  • Elimination: Half-life after subcutaneous administration of Fiasp is 57 minutes and comparable to NovoRapid.

For more information on Fiasp, please go to
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2017-PI-02153-1&d=202105241016933