Baqsimi

Emergency Treatment for Low Blood Sugar

Baqsimi is used for the emergency treatment of severe hypoglycemia in adults and children with diabetes who are at least 4 years old. Severe hypoglycemia is a serious medical condition where blood sugar levels fall so low that the person may become severely confused, lose consciousness, or have a seizure.

Because severe low blood sugar can prevent a person from being able to safely swallow food or drinks to raise their glucose levels, this medication is designed to be administered by a caregiver or bystander. It is used as a rescue treatment for people with both type 1 and type 2 diabetes.

Typical Use Cases

This medication is prescribed for patients who are at risk of experiencing dangerously low blood sugar levels, often due to the use of insulin or certain other diabetes medications. It is intended to be kept nearby at all times so it can be used immediately if an emergency occurs.

Mechanism of Action

Baqsimi contains glucagon, a synthetic version of a hormone that occurs naturally in the body. Its primary function is to increase blood sugar levels during a severe hypoglycemic emergency. When blood sugar drops to dangerous levels, the body requires a rapid source of glucose to restore normal function.

The medication works through the following process:

• Liver Stimulation: Once absorbed, the glucagon travels through the body and targets the liver.
• Glucose Conversion: It triggers the liver to convert glycogen, which is a stored form of sugar, into glucose.
• Bloodstream Release: This glucose is then released into the bloodstream, which causes blood sugar levels to rise quickly.

Nasal Absorption

Unlike other emergency treatments for low blood sugar that require an injection, Baqsimi is delivered as a dry powder through the nose. The medication is absorbed directly through the mucous membranes in the nasal passage. Because it is absorbed passively, the person receiving the dose does not need to inhale or sniff for the medication to work. This allows the treatment to be effective even if the person is unconscious or has a cold.

Common Side Effects

The most frequent side effects of Baqsimi involve the nose and throat because the medication is administered nasally. These effects are typically temporary and may include:

• Nausea and vomiting
• Headache
• Nasal congestion or runny nose
• Nasal discomfort or itching
• Sneezing
• Watery or itchy eyes
• Itchy throat

In children, side effects are generally similar to those seen in adults, though cough is also frequently reported.

Serious Side Effects

While less common, some individuals may experience serious side effects. Seek immediate medical attention if any of the following occur:

• Severe allergic reactions, such as a rash, hives, or swelling of the face, lips, or tongue
• Difficulty breathing or swallowing
• A significant increase in blood pressure
• Very fast heartbeat

Contraindications

Baqsimi should not be used by individuals with the following conditions:

• Pheochromocytoma: A tumor of the adrenal gland. Glucagon can cause the tumor to release large amounts of catecholamines, which may lead to a dangerous rise in blood pressure.
• Insulinoma: A tumor of the pancreas. In people with this condition, glucagon may trigger the release of insulin, potentially causing blood sugar levels to drop again after an initial rise.
• Hypersensitivity: A known allergy to glucagon or any of the inactive ingredients in the medication.

Serious Allergic Reactions

Severe allergic reactions are possible. Symptoms may include a widespread rash, respiratory distress, or very low blood pressure. If a serious reaction is suspected, emergency medical care is required immediately.

Limitations of Effectiveness

Baqsimi relies on the liver having enough stored sugar (glycogen) to release into the blood. It may not work effectively in people who have low glycogen stores, such as those who are starving, have adrenal insufficiency, or experience chronic hypoglycemia.

Emergency Follow-up

Because this medication is used for life-threatening low blood sugar, emergency medical help should be called immediately after administration. Once the person is awake and able to swallow, they should be given a fast-acting source of sugar, such as fruit juice, and a long-acting snack, such as crackers with cheese, to prevent another drop in blood sugar.

Pregnancy

There is limited clinical data on the use of Baqsimi specifically in pregnant individuals. However, glucagon is a hormone that occurs naturally in the body and does not cross the placenta to reach the fetus. Untreated severe low blood sugar (hypoglycemia) is a medical emergency that can lead to serious complications for both the pregnant person and the developing baby. Because of these risks, Baqsimi may be used during pregnancy if a healthcare provider determines it is necessary.

Breastfeeding

It is not known whether Baqsimi passes into human breast milk. Glucagon is a protein, and if any amount were present in breast milk, it would likely be broken down in the infant's digestive tract and not absorbed into their bloodstream. There have been no reported negative effects on nursing infants when the mother uses glucagon products. If you are breastfeeding, you should inform your doctor if you have needed to use Baqsimi to manage severe low blood sugar.

Available Forms

Baqsimi is available as a nasal powder. It is supplied in a single-use intranasal device that is ready to use without any mixing or preparation.

The device is designed to deliver the medication into the nostril as a dry powder. Each dispenser is intended for one-time use only and should be discarded after the dose is administered.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Baqsimi in July 2019. It was the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that does not require an injection. It is indicated for use in adults and pediatric patients aged 4 years and older who have diabetes.

Regulatory History

Baqsimi was originally developed and launched by Eli Lilly and Company. In 2023, the FDA approved the transfer of the drug's application to Amphastar Pharmaceuticals, following an acquisition of the product.

Safety and Monitoring

There are currently no boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) required by the FDA for this medication. It is regulated as a prescription-only emergency treatment.

Insurance and Pharmacy Factors

The amount a patient pays for Baqsimi is largely determined by their insurance plan. Most commercial insurance, Medicare Part D, and Medicaid plans cover the medication, but the specific copay or coinsurance amount varies by plan. Pharmacy prices can also fluctuate based on location and whether the pharmacy is in-network for the patient's insurance.

Financial Assistance

Manufacturer savings cards or patient assistance programs may be available for eligible individuals with commercial insurance to help lower out-of-pocket costs. These programs are typically not available for those covered by government-funded insurance like Medicare or Medicaid.

Generic Availability

There is currently no generic version of Baqsimi available. As a brand-name medication, the cost may be higher than generic glucagon injections, though the nasal delivery system is unique to this product.

Storage and Replacement

Because Baqsimi is a single-use device, it must be replaced immediately after use. It also has a specific expiration date; if the device expires before it is used, it must be replaced at the full cost allowed by the patient's insurance or pharmacy pricing to ensure it is ready for an emergency.