What to Know About Baqsimi (Glucagon Nasal Powder)

Baqsimi (glucagon nasal powder) is a medication inhaled into a nostril that is used to treat hypoglycemia (low blood sugar) in people with type 1 and type 2 diabetes. Baqsimi was approved by the U.S. Food and Drug Administration (FDA) on July 24, 2019, and is the first form of glucagon that can be used in a hypoglycemic emergency without the need for an injection.

Side effects of Baqsimi, mainly affecting the eyes and nose, tend to be mild. While effective, Baqsimi is not appropriate for everyone and may trigger an allergic reaction in some.

Glucagon is a naturally-occurring hormone produced by the pancreas that triggers the release of glucose from the liver. A 2015 study published in Diabetes Care concluded that the intranasal delivery of glucagon was as effective in treating severe hypoglycemia as a single-dose injection of glucagon.

There are no generic versions of Baqsimi.

Uses

Baqsimi is approved by the FDA for use in adults and children 4 years of age and over who have diabetes. It is intended for use in a hypoglycemic emergency when there are either no fast-acting carbohydrates (like corn syrup or orange juice) to eat or not enough to raise the blood sugar adequately. Baqsimi is not used for the general management of diabetes.

When inhaled into a nostril, Baqsimi can usually normalize blood sugar levels within 30 minutes.

Prior to the introduction of Baqsimi injectable glucagon was the only treatment available to people who experienced a hypoglycemic emergency outside of a hospital or clinic setting, defined as a blood glucose reading below 70 milligrams per deciliter (mg/dL). Such severe drops can cause serious symptoms, including irregular heart rhythms, confusion, blurred vision, seizures, and unconsciousness.

Baqsimi is considered a major advance in the emergency treatment of hypoglycemia, particularly among people who have a fear of needles. Unlike injectable glucagon, it does not require pre-mixing or significant amounts of training to administer.

Before Taking

Baqsimi is generally prescribed when you cannot adequately control fluctuations in your blood sugar despite appropriate treatment. This is especially true for people on intensive insulin therapy in whom hypoglycemia is almost inevitable.

Counseling is typically provided before Baqsimi is prescribed, especially to younger people and the elderly who often fail to recognize the early signs of hypoglycemia. By not responding immediately with oral glucose, these individuals often end up suffering an otherwise avoidable hypoglycemic event.

Lack of symptom awareness is a major risk factor for severe hypoglycemia, placing a person at nine times greater risk than someone with general knowledge.

Precautions and Contraindications

In addition to bolstering your awareness about hypoglycemia prevention, the healthcare provider will determine whether there are any conditions that might contraindicate the use of Baqsimi.

The FDA warns against the use of Baqsimi with any of the following:

• Hypersensitivity: Baqsimi should not be used if you have a known history of allergy to glucagon in any form. Hypersensitivity to either of the inactive ingredients in Baqsimi (betadex or dodecyl phosphocholine) would also contraindicate use.
• Pheochromocytoma: Baqsimi should not be used in people diagnosed with a rare tumor of the adrenal gland called pheochromocytoma in whom Baqsimi may provoke severe and potentially life-threatening hypertension (high blood pressure).
• Insulinoma: Baqsimi is also contraindicated for use in people with insulinoma, a rare tumor of the pancreas that causes the excess production of insulin. Taking Baqsimi could provoke an exaggerated insulin response and decrease your blood sugar even further.

Baqsimi should be used with caution in people with Addison's disease (adrenal insufficiency), a history of chronic hypoglycemia, or evidence of starvation. Under these circumstances, there is often not enough stored glucose in the liver to be released. Even if Baqsimi is used, there may be no response. In such cases, glucose should be used instead of glucagon.

Dosage

Baqsimi is delivered in a single-dose nasal injector containing 3 milligrams (mg) of glucagon. This is the dose recommended for both adults and children four years of age or older. Once used, the injector is thrown away.

Once the dose is delivered, call 911 and then eat some fast-acting carbs like some juice, a banana, or corn syrup. You should then try to eat a protein-rich snack, like crackers with cheese or peanut butter, which can help raise the blood sugar more gradually.

If you do not respond to Baqsimi within 15 minutes, you can give yourself another dose if available. Do not take insulin while awaiting a response.

Baqsimi can be administered to someone who is unconscious. Be sure to turn the person on their side to prevent choking if there is any vomiting. Throw away the used device and tube.

How to Store

Baqsimi should be stored in its original shrink-wrapped container until ready to use. Removing the shrink-wrap covering may allow moisture to seep in, causing the nasal powder to clump or congeal.

Baqsimi can be stored safely at temperatures of up to 86 F (30 C). Do not store Baqsimi in the glove compartment of your car where temperatures can easily exceed 100 F even in cooler weather.

Replace Baqsimi before its expiration date and throw away the expired vial. Resist the temptation to keep expired Baqsimi as a "back-up dose."

Side Effects

Like all drugs, Baqsimi may cause side effects. They mostly involve the upper respiratory tract and tend to mild and short-lasting. Severe side effects are uncommon but can occur.

Common

According to the manufacturer, common side effects of Baqsimi (affecting more than 10% of users) include:

• Runny nose
• Nasal pain
• Nasal congestion
• Itchy nose, throat or eyes
• Cough
• Nosebleed
• Watery or red eyes
• Headache
• Nausea
• Vomiting

Less commonly, changes in taste (dysgeusia), itchy skin (pruritis), rapid heart rate (tachycardia), and hypertension have been known to occur. Let your healthcare provider and emergency medical staff know of any side effects you experience after using Baqsimi.

Severe

As with a great many other drugs, Baqsimi has the potential to triggers an abnormal immune response, often in the form of a drug allergy. The symptoms of a drug allergy may be mild and resolve without treatment, while others may require emergency care.

Research suggests that the risk of an immunogenic response from glucagon is low (between 0.1% and 1.6%). With respect to Baqsimi specifically, the risk of allergy is equally low, although there have been isolated cases of anaphylaxis following the use of glucagon in other forms.

Anaphylaxis is a potentially life-threatening, whole-body allergy caused when the body overreacts to otherwise harmless substances. Symptoms tend to arise suddenly and swiftly and, if left untreated, can lead to shock, coma, asphyxiation, heart or respiratory failure, and death.

Warnings and Interactions

is relatively safe if used as indicated. If overused (more than two back-to-back doses), Baqsimi may cause nausea, reflux, vomiting, rapid heart rate, and a dramatic rise in blood pressure. If this occurs, a phentolamine mesylate injection may be prescribed to bring down the blood pressure.

As a naturally occurring hormone, glucagon tends to be safe to use with other drugs. However, there are a few drug-drug interactions worth noting:

• Beta-blockers: People who take beta-blockers to treat abnormal heart rhythms and hypertension may experience a transient rise in blood pressure and pulse after using Baqsimi.
• Warfarin: Baqsimi may slow blood clotting and increase the anticoagulant effect of the anticoagulant drug warfarin, leading to easy bruising and nosebleeds.
• Indomethacin: The nonsteroid anti-inflammatory drug indomethacin used to treat arthritis, gout, bursitis, and tendonitis may significantly undermine Baqsimi's ability to raise glucose levels.

Pregnancy

Baqsimi is believed to be safe for use in pregnancy. In rat studies, the use of injectable glucogen at levels 40 times that used in humans did not increase the risk of fetal birth defects.

Similarly, glucogen used in breastfeeding mothers appears to be broken down into its basic amino acid and posed no harm to the nursing baby.