Baqsimi

Baqsimi is used to treat very low blood sugar (severe hypoglycemia) in adults and children aged 1 year and older with diabetes. It is a nasal powder that is administered into the nose, making it easier to administer than traditional injectable glucagon. After giving Baqsimi, the caregiver should call for emergency help.

Baqsimi (glucagon) works by activating liver glucagon receptors, stimulating glycogen breakdown, and releasing glucose from the liver, increasing blood glucose levels. Liver stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect.

Baqsimi gained FDA approval on July 24, 2019. There is no generic.

You should not use Baqsimi if you are allergic to glucagon, or if you have:

• a tumor of the pancreas (insulinoma); or
• a tumor of the adrenal gland (pheochromocytoma).

Before taking, tell your healthcare provider about all your medical conditions, including if you:

• have adrenal gland problems
• have a tumor in your pancreas
• have not had food or water for a long time (prolonged fasting or starvation)
• have low blood sugar that does not go away (chronic hypoglycemia)
• are pregnant or plan to become pregnant. It is not known if Baqsimi will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if Baqsimi passes into your breast milk. You and your healthcare provider should decide if you can use Baqsimi while breastfeeding.

The most common side effects of Baqsimi include:

• nausea
• discomfort in your nose
• watery eyes
• vomiting
• stuffy nose
• redness in your eyes
• headache
• cough
• itchy nose, throat, and eyes
• runny nose
• nose bleed.

Serious side effects and warnings

Baqsimi may cause the following serious side effects:

• High blood pressure. Baqsimi can cause high blood pressure in certain people with tumors in their adrenal glands. Call your doctor at once if you have symptoms of high blood pressure, such as severe headache, blurred vision, and pounding in your neck or ears
• Low blood sugar. Baqsimi can cause certain people with tumors in their pancreas, called insulinomas, to have low blood sugar
• Serious allergic reactions. Call your healthcare provider or get medical help right away if you have a serious allergic reaction, including: rash difficulty breathing low blood pressure hives trouble swallowing feeling dizzy or faint cough swelling of the face, lips, or tongue fast heartbeat.

It is not known if Baqsimi is safe and effective in children under 1 year of age.

These are not all the possible side effects of Baqsimi. For more information, ask your healthcare provider. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Read the detailed Instructions for Use that comes with Baqsimi. Use Baqsimi exactly how your healthcare provider tells you to use it.

Make sure your caregiver and those around you know where you keep your Baqsimi and how to use Baqsimi the right way before you need their help.

• Baqsimi contains only 1 dose of medicine and cannot be reused.
• Baqsimi should be given in one side of your nose (nostril), but does not need to be inhaled.
• Baqsimi will work even if you have a cold or are taking cold medicine.
• Act quickly. Having very low blood sugar for a period of time may be harmful.
• After giving Baqsimi, the caregiver should call for emergency medical help right away.

When you can safely swallow food or drink, your caregiver should give you a fast-acting source of sugar (such as a regular soft drink or fruit juice) and a long-acting source of sugar (such as crackers with cheese or peanut butter).

If the person does not respond after 15 minutes, another dose of Baqsimi from a new device may be given, if available, while waiting for emergency services.

Tell your healthcare provider each time you use Baqsimi.

Since Baqsimi is used as needed, it does not have a daily dosing schedule.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, constipation, rapid pulse, or increased blood pressure (severe headache, blurred vision, pounding in your neck or ears).

Do not take by mouth. Nasal medicine is for use only in the nose.

Avoid drinking alcohol. It can lower your blood sugar.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of medicines used to treat diabetes. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all medicines you start or stop using.

Store Baqsimi at temperatures up to 86ºF (30ºC).

• Keep Baqsimi in the shrink-wrapped tube until you are ready to use it.
• Throw away (discard) Baqsimi and the tube after use. Used Baqsimi may be placed in household trash.

Keep out of the reach of children.

Active Ingredient: glucagon

Inactive Ingredients: betadex and dodecylphosphocholine.

Available in an intranasal device containing one dose of glucagon 3 mg.

Baqsimi (glucagon nasal powder) is made by Eli Lilly and Company (Lilly), whose global headquarters are in Indianapolis, Indiana, USA.