Baqsimi

Posology Adults, adolescents and children aged 1 year and over The recommended dose is 3 mg glucagon administered into one nostril. Elderly No dose adjustment is required based on age. Efficacy and safety data are very limited in patients aged 65 years and absent in patients aged 75 and above.

Renal impairment No dose adjustment is required based on renal function. Hepatic impairment No dose adjustment is required based on hepatic function. Paediatric population aged 0 - < 1 year The safety and efficacy of Baqsimi in infants and children aged 0 to < 1 year have not yet been established.

No data are available. Method of administration Nasal use only. Glucagon nasal powder is given in a single nostril. Glucagon is passively absorbed through the nasal mucosa. It is not necessary to inhale or breathe deeply after dosing. Patients and their caregivers should be instructed on the signs and symptoms of severe hypoglycaemia.

As severe hypoglycaemia requires the help of others to recover, the patient should be instructed to inform those around them about Baqsimi and its package leaflet. Baqsimi should be administered as 3 soon as possible when severe hypoglycaemia is recognised.

The patient or caregiver should be instructed to read the package leaflet.

The following instructions should be emphasised:

Instructions for administering glucagon nasal powder 1. Remove the shrink wrap by pulling on the red stripe. 2. Remove the single-dose container from the tube. Do not press the plunger until ready to give the dose. 3. Hold the single-dose container between fingers and thumb.

Do not test before use as it contains only one dose of glucagon and cannot be reused. 4. Insert the tip of the single-dose container gently in one of the nostrils until finger(s) touch the outside of the nose. 5. Push the plunger all the way in.

The dose is complete when the green line is no longer showing. 6. If the person is unconscious, turn the person on their side to prevent choking. 7. After giving the dose, the caregiver should call for medical help right away. 8. When the patient has responded to treatment, give oral carbohydrate to restore liver glycogen and prevent relapse of hypoglycaemia.

4.

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 increased Ocular hyperaemia Eye pruritus Respiratory, thoracic and mediastinal disorders Upper respiratory tract irritationa Gastrointestinal disorders Vomiting Nausea Skin and subcutaneous tissue disorders Pruritus Investigations Increased systolic blood pressureb Increased diastolic blood pressureb Increased heart rateb 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. 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.

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.

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. 4

1. 4).