Zegalogue

6 mg administered by a subcutaneous injection. If there has been no response after 15 minutes, an additional dose of Zegalogue from a new pre-filled syringe may be administered. Special populations Elderly Zegalogue can be used in elderly patients.

No dose adjustment is required. Efficacy and safety data are very limited in patients aged 65 years and absent in patients aged 75 and above. Renal impairment Zegalogue can be used in patients with renal impairment. No dose adjustment is required.

Hepatic impairment Zegalogue can be used in patients with hepatic impairment. No dose adjustment is required. 3 Paediatric population (< 6 years) The safety and efficacy of Zegalogue in children aged less than 6 years have not yet been established.

No data are available. Method of administration Subcutaneous use. Zegalogue is to be injected in the lower abdomen, buttocks, thigh, or outer upper arm. 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 Zegalogue and its package leaflet. Zegalogue should be administered as soon as possible when severe hypoglycaemia is recognised.

Patients and caregivers should be instructed on how to correctly use Zegalogue and to read the package leaflet.

The following instructions should be emphasised:

Instructions for use, pre-filled syringe: 1. When administering Zegalogue pre-filled syringe, insert the needle into the skin and press the plunger fully down until the syringe is empty. 2. After the injection is given, if the person is unconscious, turn the person on their side to prevent choking.

3. After giving the dose, the caregiver should call for medical help right away. 4. If there has been no response after 15 minutes, an additional dose of Zegalogue from a new pre-filled syringe may be administered while waiting for emergency assistance.

5. When the patient has responded to treatment, give oral carbohydrate to restore liver glycogen and prevent relapse of hypoglycaemia. Each pre-filled syringe contains a single dose of dasiglucagon and cannot be reused. 6.

6%). Tabulated list of adverse reactions Adverse reactions associated with dasiglucagon obtained from clinical studies are tabulated below. Adverse reactions associated with dasiglucagon are listed by system organ class and frequency.

Frequency categories are defined as: 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).

Table 1 Tabulated list of adverse reactions associated with dasiglucagon System organ class Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1 000 to < 1/100) Nervous system disorders Headache Dizziness Presyncope Cardiac disorders Palpitations Bradycardia Vascular disorders Hypotension Hypertension Hot flush Gastrointestinal disorders Nausea Vomiting Diarrhoea Abdominal pain upper Skin and subcutaneous tissue disorders Hyperhidrosis General disorders and administration site conditions Injection site erythema Injection site pruritus Injection site pain Injection site oedema Fatigue Description of selected adverse reactions 6 Hypersensitivity reactions, including anaphylactic reactions have been observed with injectable glucagon and reported as ‘very rare’ (less than 1 case per 10 000 patients) and are known medicinal class effects of glucagon.

Paediatric population Safety results in a limited paediatric population of 20 patients aged 7-17 years old, in a placebo- controlled trial were consistent with the safety profile in adults, except for nausea (65%) and vomiting (50%), which were less frequent 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.

Glycogen stores and hypoglycaemia Dasiglucagon is effective in treating hypoglycaemia only if sufficient liver glycogen is present. To prevent relapse of the hypoglycaemia, oral carbohydrates should be given to restore liver glycogen, when the patient has responded to treatment.

Patients in states of starvation, with adrenal insufficiency, chronic alcohol abuse or chronic hypoglycaemia may not have adequate levels of hepatic glycogen for dasiglucagon administration to be effective. Patients with these conditions should be treated with glucose.

Phaeocromocytoma Glucagon stimulates the release of catecholamines. In the presence of phaeocromocytoma, glucagon products can cause the tumour to release large amounts of catecholamines, which will cause an acute hypertensive reaction.

3). 4 Insulinoma In patients with insulinoma, administration of glucagon medicinal products may produce an initial increase in blood glucose. However, dasiglucagon 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 dasiglucagon should be given glucose orally or intravenously. 6 mL), that is to say essentially ‘sodium-free’. Latex In latex-sensitive individuals the medicinal product may cause severe allergic reactions.

1. 4).