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Ogluo is a brand name for Glucagon. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.
Verbatim from this product's EMA label. Tap a section to expand.
Posology Adults and adolescents (≥6 years) The recommended dose is 1 mg, administrated by subcutaneous injection. 5 mg administered by subcutaneous injection. • The recommended dose for paediatric patients who weigh 25 kg or greater is 1 mg administered by subcutaneous injection.
Time to respond and additional doses The patient will normally respond within 15 minutes. When the patient has responded to the treatment, give an oral carbohydrate to restore the liver glycogen and prevent relapse of hypoglycaemia.
If the patient does not respond within 15 minutes, an additional dose of Ogluo from a new device may be administered while waiting for emergency assistance. It is recommended that patients are prescribed two Ogluo devices. Special populations Elderly (≥ 65 years old) Ogluo 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 Ogluo can be used in patients with renal impairment. No dose adjustment is required.
Hepatic impairment Ogluo can be used in patients with hepatic impairment. No dose adjustment is required. Paediatric population (<2 years) The safety and efficacy of Ogluo in children aged less than 2 years have not been established.
No data are available. Method of administration Ogluo pre-filled pen and pre-filled syringe are for subcutaneous injection only. 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 Ogluo and its package leaflet.
Ogluo should be administered as soon as possible when severe hypoglycaemia is recognised. The patient or caregiver should be instructed to read the package leaflet at the time they receive a prescription for Ogluo. The following instructions should be emphasised: • The foil pouch should not be opened until glucagon needs to be administered.
• The medicinal product should be administered according to the printed instructions on the foil pouch label, carton, or the package leaflet. • The solution should be visually inspected prior to administration. The solution should appear clear and colourless to pale yellow and be free of particles.
Summary of the safety profile The most frequently reported adverse reactions are nausea (30%) and vomiting (16%). Tabulated list of adverse reactions Frequencies of adverse reactions considered related to treatment with Ogluo during clinical trials are presented below.
The adverse drug reactions are classified according to the System Organ Class. Frequency groups are defined by 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), and not known (cannot be estimated from available data).
Within each frequency group, adverse reactions are presented in order of decreasing seriousness. Table 1. Frequency of adverse reactions of glucagon injection System organ class Subject incidence Adverse drug reaction Nervous system disorders Common Headache Cardiac disorders Common Tachycardia 6 System organ class Subject incidence Adverse drug reaction Gastrointestinal disorders Very common Very common Common Uncommon Vomiting Nausea Diarrhoea Abdominal pain General disorders and administration site conditions Common Common Uncommon Uncommon Injection site pain Injection site oedema Injection site bruising Injection site erythema Description of selected adverse reactions The most frequently reported adverse reactions are nausea (43%), vomiting (13%), and headache (5%).
Adverse reactions are mild to moderate in severity and resolved on their own. No serious adverse reactions have been related to glucagon. Hypersensitivity reactions, including anaphylactic reactions, have been reported as ‘very rare’ (<1/10,000 patients) with injectable glucagon.
These are known medicinal product class effects of glucagon. Paediatric population The most frequently reported adverse reactions are nausea (48%), vomiting (19%), hyperglycaemia (7%), and headache (7%). Hypoglycaemia (42%) was observed in clinical trials but was not considered related to glucagon.
Glycogen stores and hypoglycaemia 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.
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. Caution should also be observed in patients with glucagonoma. Recovery time Please take into account that approximately 15% of patients achieved glucose recovery after 20 minutes or more in the pivotal trial.
1. Pheochromocytoma.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Glucagon in European Union.
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If the solution is discoloured or contains particulate matter, the medicinal product should not be used. • Any clothing covering the injection site should be removed. The injection should be administered in the lower abdomen, outer thigh, or outer upper arm.
• Emergency assistance should be called immediately after administering the dose, even if the patient is not unconsious. • Each device contains a single dose of glucagon and cannot be reused. 4
The most frequently reported adverse reactions observed by age group are presented below. Table 2. 5 mg dose) N = 11 Ages 12 to under 18 (1 mg dose) N = 11 Nausea 43% 54% 36% 36% Vomiting 14% 23% 0% 18% Hyperglycaemia 14% 8% 0% 0% Headache 0% 15% 0% 0% Other special populations Efficacy and safety data for Ogluo are very limited in patients aged 65 years and absent in patients aged 75 and above, in or pregnant patients, or patients with hepatic or renal impairment.
Based upon 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.
7 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.