Baqsimi · 4.8 Undesirable effects · 1

HOS-216751 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most frequently reported adverse reactions are lacrimation increased (36%), upper respiratory tract irritation (34%), nausea (27%), headache (21%), and vomiting (16%). Tabulated list of adverse reactions Adverse reactions are listed in table 1 as MedDRA preferred term by system organ class and frequency. The corresponding frequency category for each adverse reaction is based on 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). Table 1. Frequency of adverse reactions of glucagon nasal powder System organ class Very common Common Uncommon Nervous system disorders Headache Dysgeusia Eye disorders Lacrimation Ocular hyperaemia increased Eye pruritus Respiratory, thoracic and Upper respiratory mediastinal disorders tract irritationa Gastrointestinal disorders Vomiting Nausea Skin and subcutaneous tissue Pruritus disorders Investigations Increased systolic Increased heart blood pressureb rateb Increased diastolic blood pressureb a Upper respiratory tract irritation: rhinorrhoea, nasal discomfort, nasal congestion, nasal pruritus, sneezing, throat irritation, cough, epistaxis, and parosmia. b Increases in heart rate and blood pressure: as assessed by vital sign measurements. Frequencies are based on shifts from pre-treatment to post-treatment values. Immunogenicity Overall, 5.6% of patients developed treatment-emergent anti-glucagon antibodies. These antibodies were not neutralising and did not lower the efficacy of glucagon nor were they associated with the development of treatment-emergent adverse reactions. Paediatric population Based on data from clinical trials, the frequency, type and severity of adverse reactions observed in children aged 1 year and above are expected

Auszug; vollständigen Abschnitt im Original lesen.

HOS-216747 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Phaeochromocytoma (see section 4.4).

HOS-216746 · has-indication-information · PDF-Seite 2

Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 1 year and over with diabetes mellitus.

HOS-216749 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed. Insulin Insulin reacts antagonistically towards glucagon. Indomethacin When used with indomethacin, glucagon may lose its ability to raise blood glucose or may even produce hypoglycaemia. Beta-blockers Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be transient because of glucagon's short half-life. Glucagon treatment results in catecholamine release from the adrenal glands, and concomitant use of beta-blockers could result in unopposed alpha-adrenergic stimulation and consequently, a greater increase in blood pressure (see section 4.4). Warfarin Glucagon may increase the anticoagulant effect of warfarin.

HOS-216750 · has-pregnancy-information · PDF-Seite 4

Pregnancy Reproduction and fertility studies with glucagon nasal powder were not conducted in animals. Baqsimi can be used during pregnancy. Glucagon does not cross the human placenta barrier. The use of glucagon has been reported in pregnant women with diabetes and no harmful effects are known with respect to the course of pregnancy and the health of the unborn and the neonate. Breast-feeding Baqsimi can be used during breast-feeding. Glucagon is cleared from the bloodstream very quickly and thus the amount excreted in the milk of nursing mothers following treatment of severe hypoglycaemic reactions is expected to be extremely small. As glucagon is degraded in the digestive tract and cannot be absorbed in its intact form, it will not exert any metabolic effect in the child. Fertility No fertility studies have been conducted with glucagon nasal powder. Studies in rats have shown that glucagon does not cause impaired fertility.

HOS-216748 · has-warning-information · PDF-Seite 3

Phaeochromocytoma In the presence of phaeochromocytoma, glucagon may stimulate the release of catecholamines from the tumour. If the patient develops a dramatic increase in blood pressure, use of non-selective -adrenergic blockade has been shown to be effective in lowering blood pressure. Baqsimi is contraindicated in patients with phaeochromocytoma (see section 4.3). Insulinoma In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose. However, glucagon administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycaemia. A patient developing symptoms of hypoglycaemia after a dose of glucagon should be given glucose orally or intravenously. Hypersensitivity and allergic reactions Allergic reactions, which have been reported with injectable glucagon, may occur and include generalised rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. If the patient experiences difficulty breathing call for immediate medical assistance. Glycogen stores and hypoglycaemia Glucagon is effective in treating hypoglycaemia only if sufficient liver glycogen is present. Because glucagon is of little or no help in states of starvation, adrenal insufficiency, chronic alcohol abuse or chronic hypoglycaemia, these conditions should be treated with glucose. To prevent relapse of the hypoglycaemia, oral carbohydrates should be given to restore liver glycogen, when the patient has responded to treatment. 3