BAQSIMI Nasal powder in single-dose container Ref.[115693] Active ingredients: Glucagon

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 α-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.

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.

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.

Baqsimi has negligible influence on the ability to drive and use machines.

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia which may persist for a brief period after receiving treatment. This may present a risk in situations where these abilities are especially important, such as driving or using machines.

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:

^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 to be the same as in adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Not applicable.