FDA Approves First-Ever Nasal Glucagon for Severe Hypos in Diabetes



The US Food and Drug Administration (FDA) has approved the first nasally administered glucagonproduct (Baqsimi, Eli Lilly and Co) for the treatment of severe hypoglycemia for patients aged 4 years or older who have diabetes.

Description

Mechanism of Action

Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating
glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for glucagon
to produce an antihypoglycemic effect.

INDICATIONS AND USAGE

BAQSIMI™ is an antihypoglycemic agent indicated for the treatment of
severe hypoglycemia in patients with diabetes ages 4 years and above.

DOSAGE

BAQSIMI is for intranasal use only.
• The recommended dose of BAQSIMI is 3 mg administered as one
actuation of the intranasal device into one nostril.
• Administer BAQSIMI according to the printed instructions on the
shrink-wrapped tube label and the Instructions for Use.
• Administer the dose by inserting the tip into one nostril and
pressing the device plunger all the way in until the green line is no
longer showing. The dose does not need to be inhaled.
• Call for emergency assistance immediately after administering the
dose.
• When the patient responds to treatment, give oral carbohydrates.

• Do not attempt to reuse BAQSIMI. Each BAQSIMI device contains
one dose of glucagon and cannot be reused.
• If there has been no response after 15 minutes, an additional 3 mg
dose may be administered while waiting for emergency assistance.

CONTRAINDICATIONS

  1. Pheochromocytoma
  2. Insulinoma
  3. Known hypersensitivity to glucagon or to any of the excipients

WARNINGS AND PRECAUTIONS

• Catecholamine Release in Patients with Pheochromocytoma:
Contraindicated in patients with pheochromocytoma because
BAQSIMI may stimulate the release of catecholamines from the
tumor.
• Lack of Efficacy in Patients with Insulinoma: In patients with
insulinoma, administration may produce an initial increase in blood
glucose; however, BAQSIMI may stimulate exaggerated insulin
release from an insulinoma and cause hypoglycemia. If a patient
develops symptoms of hypoglycemia after a dose of BAQSIMI,
give glucose orally or intravenously.
• Hypersensitivity and Allergic Reactions: Allergic reactions have
been reported and include generalized rash, and in some cases
anaphylactic shock with breathing difficulties, and hypotension.
• Lack of Efficacy in Patients with Decreased Hepatic Glycogen:
BAQSIMI is effective in treating hypoglycemia only if sufficient
hepatic glycogen is present. Patients in states of starvation, with
adrenal insufficiency or chronic hypoglycemia may not have
adequate levels of hepatic glycogen for BAQSIMI to be effective.

ADVERSE REACTIONS

Most common (≥10%) adverse reactions associated with BAQSIMI are
nausea, vomiting, headache, upper respiratory tract irritation (i.e.,
rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis),
watery eyes, redness of eyes, itchy nose, throat and eyes.

Reference:

FDA News