Baqsimi for treating severe hypoglycemia in patients with diabetes

Baqsimi is a glucagon nasal powder used to treat severe hypoglycemia (very low blood sugar) in adults and children aged 1 year and older with diabetes. It is a single-dose, intranasal medication designed for emergency use when a person with diabetes experiences severe low blood sugar and cannot eat or drink sugar by mouth.

Baqsimi is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes aged 1 year and older. It is intended for emergency use when immediate treatment of low blood sugar is needed.

glucagon

Baqsimi contains glucagon, a hormone that raises blood glucose levels by stimulating the liver to release stored glucose. This helps quickly reverse severe hypoglycemia by increasing blood sugar when it falls dangerously low due to diabetes or insulin use.

Recommended dose: One 3 mg intranasal actuation into one nostril.

Administration instructions:

• Use Baqsimi only intranasally by placing the tip of the device into the nostril.
• Press the plunger fully until the green line is no longer visible; no inhalation is needed.
• Do not push the plunger or test the device before actual use.

After administration: Call emergency services immediately.

If no response occurs within 15 minutes, give a second 3 mg dose from a new device while waiting for medical help.

When the patient recovers, provide oral carbohydrates to replenish liver glycogen and prevent recurrence of low blood sugar.

Important: Baqsimi devices contain a single dose and must not be reused. Discard any unused portion.

Baqsimi is contraindicated in patients with:

• Pheochromocytoma due to risk of substantial blood pressure increase.
• Insulinoma due to risk of hypoglycemia.
• Prior hypersensitivity to glucagon or any excipients in Baqsimi.

Contraindications:

• Patients with pheochromocytoma (risk of dangerous blood pressure increases).
• Patients with insulinoma (risk of hypoglycemia).
• Patients with known hypersensitivity or prior serious allergic reaction to glucagon or any excipient in Baqsimi.

Precautions:

• Baqsimi may not be effective in patients with low hepatic glycogen stores, such as those with starvation, adrenal insufficiency, or chronic hypoglycemia; glucose should be used instead.
• Severe hypersensitivity reactions, including anaphylaxis, have occurred; discontinue immediately if symptoms develop and seek urgent care.
• If a previously undiagnosed pheochromocytoma is suspected after Baqsimi use with hypertensive crisis, intravenous phentolamine mesylate (5-10 mg) can be used to lower blood pressure.

Common adverse reactions (≥10% incidence) include:

• Nausea
• Vomiting
• Headache
• Upper respiratory tract irritation such as nasal discomfort, congestion, runny nose, sneezing, cough, and nosebleeds
• Watery, red, or itchy eyes
• Itching of the nose, throat, or ears

Less common reactions: Dysgeusia (altered taste), pruritus (itching), tachycardia, hypertension, nasal pruritus, throat irritation, and parosmia.

Drug interactions:

• Beta-blockers: May cause transient increases in heart rate and blood pressure.
• Indomethacin: May reduce Baqsimi’s ability to raise blood glucose or cause hypoglycemia.
• Warfarin: May enhance anticoagulant effects of warfarin.

Pregnancy: Available data from case reports and observational studies over decades do not indicate increased risks of birth defects, miscarriage, or adverse pregnancy outcomes with glucagon. Studies show glucagon does not cross the placenta significantly during early gestation. Animal studies at doses up to 40 times human exposure showed no embryofetal harm.

Lactation: There is no information on glucagon in human milk, but it is expected to be broken down in the infant’s digestive tract and unlikely to cause harm.

Information on overdose is not explicitly provided in the supplied label excerpt.

Store Baqsimi nasal powder as instructed on the packaging. Specific storage conditions are not detailed in the provided label excerpt.