Suliqua · 4.4 Special warnings and precautions for use · 1

HOS-097927 · has-adverse-reaction-information · PDF-Seite 10

Summary of the safety profile The most frequently reported adverse reactions during treatment with Suliqua were hypoglycaemia and gastrointestinal adverse reactions (see section 'Description of selected adverse reactions' below). Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing frequency (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; not known: cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1: Adverse drug reactions reported System organ Frequency class Very common Common Uncommon Rare Not Known Infections and Nasopharyngitis infestations Upper respiratory tract infection Immune system Urticaria disorders Metabolism and Hypoglycaemia nutrition disorders Nervous system Dizziness Headache disorders Dysgeusia Gastrointestinal Nausea Dyspepsia Delayed gastric disorders Diarrhoea Abdominal pain emptying Vomiting Hepatobiliary Cholelithiasis disorders Cholecystitis Skin and Cutaneous subcutaneous amyloidosis tissue disorders Lipodystrophy General disorders Injection site Fatigue and administration reactions site conditions 10 Description of selected adverse reactions Hypoglycaemia The following table describes the rate of documented symptomatic hypoglycaemia (≤ 3.9 mmol/L) and severe hypoglycaemia for both Suliqua and the comparator***. Table 2: Documented

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097923 · has-contraindication-information · PDF-Seite 5

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

HOS-097922 · has-indication-information · PDF-Seite 2

Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without sodium-glucose co-transporter-2 (SGLT-2) inhibitors. For study results with respect to effect on glycaemic control, and the populations studied, see section 4.4 and 5.1.

HOS-097925 · has-interaction-information · PDF-Seite 7

No interaction studies with Suliqua have been performed. The information given below is based on studies with the monocomponents. Pharmacodynamic interactions A number of substances affect glucose metabolism and may require dose adjustment of Suliqua. Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include anti-hyperglycaemic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics. Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g., epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g., clozapine and olanzapine) and protease inhibitors. Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent. Pharmacokinetic interactions Lixisenatide is a peptide and is not metabolised by cytochrome P450. In in vitro studies, lixisenatide did not affect the activity of cytochrome P450 isozymes or human transporters tested. No pharmacokinetic interactions are known for insulin glargine. 7 Effect of gastric emptying on oral medicinal products The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products. Patients receiving medicinal products of either a narrow therapeutic ratio or medicinal products that require careful clinical monitoring should be followed closely, especially at the time of initiation of lixisenatide treatment. These medicinal products should be taken in a standardised way in relation to lixisenatide. If such medicinal products are to be administered with food, patients should be advised to, if possible, take them with a meal when lixisenatide is not administered. For oral medicinal products that are particularly d

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097926 · has-pregnancy-information · PDF-Seite 9

Women of childbearing potential Suliqua is not recommended in women of childbearing potential not using contraception. Pregnancy There is no clinical data on exposed pregnancies from controlled clinical studies with use of Suliqua, insulin glargine, or lixisenatide. A large amount of data on pregnant women (more than 1 000 pregnancy outcomes) with insulin glargine indicate no malformative nor feto/neonatal toxicity of insulin glargine. Animal data do not indicate reproductive toxicity with insulin glargine. There are no or limited amount of data from the use of lixisenatide in pregnant women. Studies with lixisenatide in animals have shown reproductive toxicity (see section 5.3). Suliqua is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding It is unknown whether insulin glargine or lixisenatide are excreted in human milk. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Suliqua. Fertility Animal studies with lixisenatide or insulin glargine do not indicate direct harmful effects with respect to fertility. 9

HOS-097924 · 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. Type 1 diabetes Suliqua should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Rotation of the injection site Patients 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 control 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. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medicinal product may be considered. Hypoglycaemia Hypoglycaemia was the most frequently reported observed adverse reaction during treatment with Suliqua (see section 4.8). Hypoglycaemia may occur if the dose of Suliqua is higher than required. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. These factors 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) - inadequate food intake - 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). 5 - Suliqua dose increase in patients with already adequate or tight glucose control - lixisenatide and/or insulin in combination with a sulfonylurea may result in an increased risk of hypoglycaemia. Therefore, Suliqua should not be given in combination with a sulfonylurea. The dose of Suliqua must be individualised based on clinical response and is titrated based on the patient’s need for insulin (see section 4.2). Acute pancreatitis Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis. There have been few reported events of acute pancreatitis with lixisenatide although a causal relationship has not be

Auszug; vollständigen Abschnitt im Original lesen.