Insulin-Formulation_Fiasp

• 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 usedin 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.
• 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)
• Penfill/FlexTouch: Needles and Fiasp Penfill/Fiasp FlexTouch must not be shared. The cartridge must not be refilled.
• Do not use Fiasp unless the solution appears 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 has 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.