Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Amphastar France Pharmaceuticals, Usine Saint Charles, Eragny Sur Epte, 60590, France
Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 1 year and over with diabetes mellitus.
The recommended dose is 3 mg glucagon administered into one nostril.
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.
No dose adjustment is required based on renal function.
No dose adjustment is required based on hepatic function.
The safety and efficacy of Baqsimi in infants and children aged 0 to <1 year have not yet been established. No data are available.
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 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.
For special warnings and precautions for use see section 4.4.
If overdose occurs, the patient may experience nausea, vomiting, inhibition of gastrointestinal tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, use of non-selective α-adrenergic blockade has been shown to be effective in lowering blood pressure for the short time that control would be needed (see section 4.4).
2 years.
Do not store above 30°C.
Keep the single-dose container in the shrink-wrapped tube until ready to use in order to protect from moisture.
The single-dose container consists of polyethylene and polypropylene.
The shrink-wrapped tube is comprised of polyethylene and polypropylene containing a desiccant.
Pack sizes of 1 or 2 single-dose containers.
Not all pack sizes may be marketed.
This is a ready to use medicinal product and for single-use only.
The single-dose container contains only one dose and therefore it must not be primed or tested prior to use.
The instructions for using the medicinal product in the package leaflet must be followed carefully.
If the tube has been opened, the single-dose container may have been exposed to moisture. This could cause the medicinal product to not work as expected. Examine the shrink wrapped tube periodically. If the tube has been opened, replace the medicinal product.
Discard nasal glucagon single-dose container and tube after use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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