Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Phaeocromocytoma.
Due to the instability of GlucaGen in solution, the product should be given immediately after reconstitution and must not be given as an intravenous infusion.
To prevent relapse of the hypoglycaemia, oral carbohydrates should be given to restore the liver glycogen, when the patient has responded to the treatment.
Glucagon will not be effective in patients whose liver glycogen is depleted. For that reason, glucagon has little or no effect when the patient has been fasting for a prolonged period, or is suffering from adrenal insufficiency, chronic hypoglycaemia or alcohol induced hypoglycaemia.
Glucagon, unlike adrenaline, has no effect upon muscle phosphorylase and therefore cannot assist in the transference of carbohydrate from the much larger stores of glycogen that are present in the skeletal muscle.
Persons who have been given glucagon in connection with diagnostic procedures may experience discomfort, in particular if they have been fasting. Nausea, hypoglycaemia, and blood pressure changes have been reported in these situations. After the end of a diagnostic procedure, oral carbohydrates should be given to patients who have been fasting, if this is compatible with the diagnostic procedure applied. If fasting is needed post-examination or in case of severe hypoglycaemia, glucose given intravenously may be required.
Glucagon reacts antagonistically towards insulin and caution should be observed if GlucaGen is used in patients with insulinoma. Caution should also be observed in patients with glucagonoma.
Caution should be observed when GlucaGen is used as an adjunct in endoscopic or radiographic procedures in diabetic patients or in elderly patients with known cardiac disease.
Glucagon stimulates the release of catecholamines. In the presence of phaeocromocytoma, glucagon can cause the tumour to release large amounts of catecholamines, which will cause an acute hypertensive reaction. Glucagon is contraindicated in patients with phaeochromocytoma (see section 4.3).
GlucaGen contains less than 1mmol sodium (23mg) per maximum dose (2 ml), that is to say essentially ‘sodium-free’.
Insulin: Reacts antagonistically towards glucagon.
Indomethacin: Glucagon may lose its ability to raise blood glucose or paradoxically may even produce hypoglycaemia.
Warfarin: Glucagon may increase the anticoagulant effect of warfarin.
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 temporary because of glucagon’s short half-life. The increase in blood pressure and pulse rate may require therapy in patients with coronary artery disease.
Interactions between GlucaGen and other drugs are not known when GlucaGen is used in the approved indications.
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. GlucaGen can be used during pregnancy.
Glucagon is cleared from the bloodstream very fast (mainly by the liver) (t1/2= 3–6 min.); 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. GlucaGen can be used during breast-feeding.
Animal reproduction studies have not been conducted with GlucaGen. Studies in rats have shown that glucagon does not cause impaired fertility.
After a severe hypoglycaemic event, the patient’s ability to concentrate and react may be impaired. Therefore the patient should not drive or operate machinery after a severe hypoglycaemic event until the patient has stabilised.
After diagnostic procedures hypoglycaemia has been reported infrequently. Therefore driving a vehicle and operating machinery should be avoided until the patient has had a meal with oral carbohydrates.
Severe adverse reactions are very rare, although nausea, vomiting and abdominal pain may occur occasionally. Hypersensitivity reactions, including anaphylactic reactions, have been reported as ‘very rare’ (less than 1 case per 10,000 patients). When used in the diagnostic indication, hypoglycaemia/hypoglycaemic coma have been reported, especially in patients who have fasted. Cardiovascular adverse events, such as tachycardia and blood pressure changes have only been reported when GlucaGen is used as an adjunct in endoscopic or radiographic procedures.
Frequencies of undesirable effects considered related to treatment with GlucaGen during clinical trials and/or post-marketing surveillance are presented below. Undesirable effects which have not been observed in clinical trials, but have been reported spontaneously, are presented as ‘very rare’. During marketed use reporting of adverse drug reactions is very rare (<1/10,000). However, post-marketing experience is subject to under-reporting and this reporting rate should be interpreted in that light.
Therapeutic indication:
| System Organ Class | Subject incidence | Adverse drug reaction |
|---|---|---|
| Immune system disorders | Very rare <1/10,000 | Hypersensitivity reactions including anaphylactic reaction/shock |
| Gastrointestinal disorders | Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 | Nausea Vomiting Abdominal pain |
Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in children are expected to be the same as in adults.
Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment are expected to be the same as in the general population.
Diagnostic indication:
| System Organ Class | Subject incidence | Adverse drug reaction |
|---|---|---|
| Immune system disorders | Very rare <1/10,000 | Hypersensitivity reactions including anaphylactic reaction/shock |
| Metabolism and nutrition disorders | Uncommon ≥1/1,000 to <1/100 Very rare <1/10,000 | Hypoglycaemia*1 Hypoglycaemic coma |
| Cardiac disorders | Very rare <1/10,000 | Tachycardia*2 |
| Vascular disorders | Very rare <1/10,000 Very rare <1/10,000 | Hypotension*2 Hypertension*2 |
| Gastrointestinal disorders | Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 | Nausea Vomiting Abdominal pain |
*1 After a diagnostic procedure this could be more pronounced in patients that have fasted (see section 4.4).
*2 Cardiovascular adverse events have only been reported when GlucaGen is used as an adjunct in endoscopic or radiographic procedures.
There are no data available on the diagnostic use of GlucaGen in children.
Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment are expected to be the same as in the general population.
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
There are no known incompatibilities with GlucaGen.
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