Fiasp · 4.6 Fertility, pregnancy and lactation · 1

HOS-217133 · has-adverse-reaction-information · PDF-Seite 8

Summary of safety profile 8 The most frequently reported adverse reaction during treatment is hypoglycaemia (see section ‘Description of selected adverse reactions’ below). Tabulated list of adverse reactions Adverse reactions listed below (Table 2) are based on data from 6 completed therapeutic confirmatory trials in adults. Frequency categories are defined according to the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data). Table 2 Adverse reactions from clinical trials MedDRA system organ Very common Common Uncommon Not known class Immune system Hypersensitivity Anaphylactic disorders reactions Metabolism and Hypoglycaemia nutrition disorders Skin and subcutaneous Allergic skin Lipodystrophy Cutaneous tissue disorders manifestations amyloidosis† General disorders and Injection/infus administration site ion site conditions reactions † ADR from postmarketing sources. Description of selected adverse reactions Allergic reactions Allergic skin manifestations reported with Fiasp (1.8% vs. 1.5% for comparator) include eczema, rash, rash pruritic, urticaria and dermatitis. With Fiasp generalised hypersensitivity reactions (manifested by generalised skin rash and facial oedema) was reported uncommonly (0.2% vs. 0.3% for comparator). Hypoglycaemia Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation (see sections 4.4 and 5.1). Hypoglycaemia may occur earlier after an injection/infu

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HOS-217129 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 5

HOS-217128 · has-indication-information · PDF-Seite 2

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

HOS-217131 · has-interaction-information · PDF-Seite 7

7 A number of medicinal products are known to interact with the glucose metabolism. The following substances may reduce insulin requirement: Oral antidiabetics, monoamine oxidase inhibitors (MAOIs), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids, sulphonamides and GLP-1 receptor agonist. The following substances may increase insulin requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol. Beta-blocking agents may mask the symptoms of hypoglycaemia. Octreotide/lanreotide may either increase or decrease the insulin requirement. Alcohol may intensify or reduce the hypoglycaemic effect of insulin.

HOS-217132 · has-pregnancy-information · PDF-Seite 8

Pregnancy Fiasp can be used in pregnancy. Data from two randomised controlled clinical trials conducted with insulin aspart (322 + 27 exposed pregnancies) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/new born when compared to soluble human insulin. Intensified blood glucose control and monitoring of pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes) are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters. After delivery, insulin requirements normally return rapidly to pre-pregnancy values. Breast-feeding There are no restrictions on treatment with Fiasp during breast-feeding. Insulin treatment of the breast-feeding mother presents no risk to the baby. However, the dose may need to be adjusted. Fertility Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding fertility.

HOS-217130 · has-warning-information · PDF-Seite 6

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypoglycaemia Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.8 and 4.9). Patients, whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly. Usual warning symptoms may disappear in patients with long-standing diabetes. The timing of hypoglycaemia usually reflects the time-action profile of the administered insulin formulation. Hypoglycaemia may occur earlier after an injection/infusion when compared to other mealtime insulins due to the earlier onset of action of Fiasp (see section 5.1). Since Fiasp should be administered up to 2 minutes before the start of the meal with the option to administer up to 20 minutes after starting the meal, the time to onset of action must be taken into account when prescribing to patients with concomitant diseases or treatment where a delayed absorption of food might be expected. Paediatric population Close monitoring of blood glucose levels is recommended if administering this medicinal product after the start of the last meal of the day, in order to avoid nocturnal hypoglycaemia. Hyperglycaemia and diabetic ketoacidosis 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. Continuous subcutaneous insulin infusion (CSII) Pump or infusion set malfunctions can lead to a fast onset of hyperglycaemia and ketosis. Prompt identification and correction of the cause of hyperglycaemia or ketosis is necessary. Interim therapy with subcutaneous injection may be required. Misuse of PumpCart The cartridge (PumpCart) is only for use with an insulin infusion pump system designed to be used with this cartridge. It must not be used with other devices not designed for the cartridge, as this may result in incorrect insulin dosing and subsequent hyper- or hypoglycaemia (see section 6.6). Skin and subcutaneous tissue disorders Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing l

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