Summary of the safety profile
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.
Tabulated summary of adverse reactions
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 |
| General disorders and administration site conditions | Not known (cannot be estimated from the available data) | Injection site reactions |
Paediatric population
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.
Other special populations
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 |
| General disorders and administration site conditions | Not known (cannot be estimated from the available data) | Injection site reactions |
*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.
Paediatric population
There are no data available on the diagnostic use of GlucaGen in children.
Other special populations
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 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 Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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