Baqsimi for treating severe hypoglycemia in diabetes patients aged 1 year and older

Baqsimi is a nasal powder form of glucagon approved for treating severe hypoglycemia in people with diabetes aged 1 year and older. It provides emergency treatment when blood sugar levels drop dangerously low and requires assistance from others to recover.

Baqsimi is indicated for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes.

glucagon

Glucagon, the active ingredient in Baqsimi, works by stimulating the liver to release stored glucose into the bloodstream. This raises blood sugar levels to counteract severe hypoglycemia, a condition where blood glucose levels fall too low.

Administration: Baqsimi is for intranasal use only. Administer one 3 mg dose by inserting the tip of the intranasal device into one nostril and pressing the plunger fully until the green line disappears. The dose does not need to be inhaled.

Dosage: One actuation (3 mg) per episode of severe hypoglycemia in patients aged 1 year and above.

If no response: If the patient does not respond within 15 minutes, a second 3 mg dose from a new device may be administered while awaiting emergency help.

After recovery: When the patient responds, oral carbohydrates should be given to restore liver glycogen and prevent recurrent hypoglycemia.

Important points: Do not reuse the device. Discard any unused portion. Call emergency assistance immediately after administration. Patients and caregivers should be trained on proper use and the signs of severe hypoglycemia.

Baqsimi is contraindicated in patients with pheochromocytoma, insulinoma, and patients with prior hypersensitivity reactions to glucagon or any excipients.

Contraindicated in:

• Patients with pheochromocytoma, due to risk of significant blood pressure increase from catecholamine release.
• Patients with insulinoma, as glucagon may cause hypoglycemia via exaggerated insulin release.
• Patients with known hypersensitivity to glucagon or any excipients, including risk of severe allergic reactions (anaphylaxis).

Precautions:

• BAQSIMI is ineffective if hepatic glycogen stores are insufficient (e.g., starvation, adrenal insufficiency, chronic hypoglycemia).
• If increased blood pressure occurs in patients with suspected pheochromocytoma, intravenous phentolamine mesylate may be required.
• Severe hypersensitivity reactions require immediate discontinuation and emergency medical care.

Common adverse reactions (≥10% incidence):

• Nausea
• Vomiting
• Headache
• Upper respiratory tract irritation: rhinorrhea, nasal discomfort, nasal congestion, cough, epistaxis
• Watery eyes
• Redness and itching of eyes and nose

Other observed adverse reactions: dysgeusia (taste disturbances), pruritus, tachycardia, hypertension, nasal pruritus, throat irritation, and parosmia.

Drug interactions to note:

• Beta-blockers: May cause transient increases in heart rate and blood pressure.
• Indomethacin: Glucagon may lose effectiveness in raising blood glucose or may cause hypoglycemia.
• Warfarin: BAQSIMI may enhance anticoagulant effects.

Available data from case reports and small observational studies do not indicate risk of major birth defects, miscarriage, or adverse maternal/fetal outcomes from glucagon use in pregnancy. Animal studies with high doses of glucagon showed no embryofetal toxicity. The presence of glucagon in human or animal milk is unknown but is expected to be broken down in the infant's digestive tract and unlikely to cause harm.

Specific overdose information is not provided in the supplied label text.

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