Awiqli · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-100335 · has-adverse-reaction-information · PDF-Seite 9

Summary of the safety profile The most frequently reported adverse reaction during clinical trials with insulin icodec is hypoglycaemia (see sections 4.4 and 5.1). Tabulated list of adverse reactions The overall safety profile of insulin icodec is based on six phase 3 (ONWARDS 1-6) trials where a total of 2 170 patients were exposed to insulin icodec, 1 880 with type 2 diabetes and 290 with type 1 diabetes. Adverse reactions listed below are based on clinical trial data and classified according to MedDRA System Organ Class. 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 Tabulated list of adverse reactions MedDRA Very common Common Uncommon Rare system organ classes Immune system Hypersensitivity*** disorders Metabolism and Hypoglycaemia* nutrition disorders General Injection site disorders and reaction administration site conditions Peripheral oedema** Skin and Lipodystrophy subcutaneous tissue disorders * Hypoglycaemia is defined below ** Grouped term covering adverse events related to peripheral oedema *** Grouped term covering adverse events related to hypersensitivity. Description of selected adverse reactions Hypoglycaemia Hypoglycaemia is the most commonly observed adverse drug reaction in patients using insulin icodec (see sections 4.4 and 5.1). 9 In phase 3 clinical trials with insulin icodec, severe hypoglycaemia was defined as hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery and clinically significant hypoglycaemia was defined as plasma glucose value less than 54 mg/dL (3.0 mmol/L). Type 2 diabetes The proportion of patients reporting severe or clinically significant hypoglycaemic episodes for insulin icodec vs daily basal insulin was 9%-12% vs 6%-11% in insulin naïve type 2 diabetes patients (ONWARDS 1, 3 and 5), 14% vs 7% in type 2 diabetes patients previously treated wi

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HOS-100331 · has-contraindication-information · PDF-Seite 5

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

HOS-100330 · has-indication-information · PDF-Seite 2

Treatment of diabetes mellitus in adults.

HOS-100333 · has-interaction-information · PDF-Seite 8

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

HOS-100334 · has-pregnancy-information · PDF-Seite 8

Pregnancy There is no clinical experience with use of insulin icodec in pregnant women. Animal reproduction studies with insulin icodec have not revealed any effects regarding embryotoxicity and teratogenicity. Because of lack of experience during pregnancy, women of childbearing potential should be advised to discontinue Awiqli, if they become pregnant or wish to become pregnant. Breast-feeding It is unknown whether insulin icodec is excreted in human milk. Available pharmacodynamic/ toxicological data in rats have shown excretion of insulin icodec in milk. A risk to the newborns/ infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from insulin icodec therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility Animal reproduction studies with insulin icodec have not revealed any adverse reactions on fertility. 8

HOS-100332 · has-warning-information · PDF-Seite 5

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. 5 Hypoglycaemia Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.5, 4.8 and 4.9). Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. 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. 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 must be advised accordingly. Usual warning symptoms may disappear in patients with long-standing diabetes. The possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered. Patient adherence to the dose and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring. These include: – change in the injection area – improved insulin sensitivity (e.g., by removal of stress factors) – unaccustomed, increased or prolonged physical activity – intercurrent illness (e.g., vomiting, diarrhoea, fever) – inadequate food intake and missed meals – alcohol consumption – certain uncompensated endocrine disorders, (e.g., in hypothyroidism and in anterior pituitary or adrenocortical insufficiency) – concomitant treatment with certain other medicinal products (see section 4.5). The prolonged effect of Awiqli may delay recovery from hypoglycaemia. Upon onset of a hypoglycaemic episode, patient is recommended to closely measure blood glucose until recovery. Patients with type 1 diabetes For type 1 diabetes patients treated with insulin icodec there was a higher risk of hypoglycaemia compared to insulin degludec (see sections 4.8 and 5.1). Patients with typ

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