Peptide education
Glucagon
BAQSIMI · GVOKE
Glucagon is a peptide hormone that helps raise blood glucose. Some prescription glucagon products treat severe low blood sugar in people with diabetes. Another formulation is used by clinicians during certain imaging exams to temporarily reduce movement in the digestive tract.
Rescue glucagon treats severe hypoglycemia but does not replace emergency care. The BAQSIMI and GVOKE labels direct users to call for emergency assistance immediately after giving a dose.
Overview
Quick answer
A nasal rescue powder, a subcutaneous rescue injection, and an intravenous diagnostic vial are different products with different instructions. The amount in one formulation cannot simply be substituted for another.
How does glucagon raise blood sugar?
It activates glucagon receptors in the liver, prompting the release of glucose from stored glycogen. The rescue effect depends on having enough glycogen in the liver.
What is it approved to treat?
BAQSIMI and GVOKE rescue products are labeled for severe hypoglycemia in people with diabetes. Their minimum ages differ. A separate product, GVOKE VialDx, is labeled for use during adult radiologic examinations.
Which rescue products are described here?
BAQSIMI is a nasal powder labeled for people with diabetes aged 1 year and older. GVOKE rescue presentations are injected under the skin and are labeled from age 2. Each product has its own directions.
Does a rescue dose replace emergency care?
No. Both product labels say to call for emergency assistance immediately after the dose. They also describe a further dose if the person has not responded after 15 minutes while help is on the way.
Can glucagon fail to work?
Yes. People with insufficient liver glycogen, including in starvation, adrenal insufficiency, or chronic hypoglycemia, may not respond adequately. The labels discuss glucose treatment in those situations.
Evidence
Evidence snapshot
BAQSIMI and GVOKE are FDA-approved for this use in people with diabetes, with different minimum ages and product-specific instructions.
A randomized crossover study tested both routes after insulin-induced hypoglycemia. Of the adults with type 1 diabetes who received at least one dose, 75 completed both visits and were included in the efficacy analysis.
GVOKE VialDx is an intravenous product labeled to temporarily inhibit gastrointestinal movement during radiologic examinations in adults.
Rescue treatment can be ineffective when liver glycogen stores are too low. Emergency assistance is needed even after medication is given.
Claims
Common claims vs evidence
| Claim | Human evidence | Mechanistic evidence | Verdict |
|---|---|---|---|
| Nasal glucagon and injected glucagon are identical in every respect. | In a supervised crossover study, glucose reached at least 70 mg/dL or rose at least 20 mg/dL from its lowest level within 30 minutes without additional glucose-raising treatment at 74 of 75 nasal visits and all 75 intramuscular visits. Among visits where the lowest glucose level was below 50 mg/dL, mean time to that threshold was 16 minutes for 58 nasal visits and 13 minutes for 44 intramuscular visits. | The study supports the tested nasal formulation, but different dose amounts and routes were used, and response times were not identical. | |
| A glucagon rescue dose means emergency help is unnecessary. | The rescue labels direct users to call emergency assistance immediately after giving BAQSIMI or GVOKE. Both also describe what to do if there is no response after 15 minutes. | Rescue medication is part of an emergency response, not a substitute for it. | |
| Any glucagon product can be used for any glucagon indication. | BAQSIMI is a nasal rescue product, GVOKE rescue presentations are subcutaneous, and GVOKE VialDx is labeled for intravenous diagnostic use in adults. | Match the product, route, and instructions to the prescribed indication. | |
| Glucagon always raises glucose in severe hypoglycemia. | The rescue effect requires sufficient hepatic glycogen. The labels warn that some people with depleted stores may not respond adequately. | A response is not guaranteed. The need for emergency assistance remains. |
Bottom line
Main takeaway
Severe low blood sugar is an emergency. Prescribed rescue glucagon has product-specific instructions, and the labels say to call for emergency assistance immediately after a dose.
Nasal BAQSIMI and injected GVOKE have different minimum ages, routes, devices, and doses. The diagnostic GVOKE VialDx is a separate product.
A crossover trial measured glucose recovery after insulin-induced hypoglycemia under supervision. The prescribing labels specify each product's indications and precautions.
Identity
What it is
Glucagon is a 29-amino-acid peptide hormone. Medicinal glucagon can be supplied in different formulations for different clinical purposes.
Rescue products are used for severe hypoglycemia in people with diabetes. A separate intravenous formulation can temporarily inhibit movement of the gastrointestinal tract for radiologic examinations.
Use context
Routes, doses, and cycle patterns
BAQSIMI is a nasal powder, while GVOKE rescue products are injected under the skin. Their labeled doses and age ranges differ. Both labels call for emergency assistance immediately after a rescue dose.
Human studies and product labels
BAQSIMI rescue label
- Purpose
- Severe hypoglycemia in people with diabetes aged 1 year and older
- Context
- Approved nasal rescue product
- Route
- Intranasal powder
- Amount
- 3 mg in a single-use device
- Frequency
- One dose; the label permits another from a new device after 15 minutes if no response
The label says to call for emergency assistance immediately after the dose. Give oral carbohydrates when the person responds and can swallow safely. Each device contains one dose.
GVOKE rescue label
- Purpose
- Severe hypoglycemia in people with diabetes aged 2 years and older
- Context
- Approved subcutaneous rescue products
- Route
- Subcutaneous
- Amount
- 1 mg at age 12 or older; ages 2 to under 12 receive 0.5 or 1 mg according to weight
- Frequency
- One dose; the label permits another from a new device or kit after 15 minutes if no response
For ages 2 to under 12, the label specifies 0.5 mg below 45 kg and 1 mg at 45 kg or above. Call for emergency assistance immediately after the dose; the label calls for oral carbohydrates once the person responds and can swallow safely.
GVOKE VialDx diagnostic label
- Purpose
- Temporarily reduce gastrointestinal movement during adult radiologic exams
- Context
- Separate diagnostic formulation under medical supervision
- Route
- Intravenous
- Amount
- Procedure-specific labeled doses
- Frequency
- Selected by the treating clinical team for the examination
This product is labeled for diagnostic use, not as the subcutaneous GVOKE rescue presentation. It has its own instructions and precautions.
Nasal versus intramuscular crossover study
- Purpose
- Reversal of supervised insulin-induced hypoglycemia
- Context
- Randomized crossover trial
- Route
- Intranasal compared with intramuscular
- Amount
- 3 mg nasal compared with 1 mg intramuscular
- Frequency
- One dose at each separate study visit
The trial measured glucose recovery within 30 minutes in adults with type 1 diabetes. The nasal and intramuscular formulations used different dose amounts and routes.
What varies
- Age and weight requirements depend on the named rescue product. A caregiver should know the prescribed device before an emergency.
- Rescue glucagon may not work adequately when liver glycogen is depleted. Emergency treatment and follow-up are still necessary.
Research
Research evidence
A randomized crossover trial in adults with type 1 diabetes compared nasal and intramuscular glucagon after hypoglycemia was induced with insulin. It measured glucose recovery under supervision. BAQSIMI and GVOKE have different labeled ages and doses for severe hypoglycemia in diabetes.
| Study / evidence area | Population | Design | Product context | Main outcome | Limitations | Weight |
|---|---|---|---|---|---|---|
| Nasal versus intramuscular glucagon | 75 adults with type 1 diabetes completed both visits for efficacy analysis; 77 received at least one dose for safety analysis | Randomized crossover noninferiority study after insulin-induced hypoglycemia | 3 mg nasal glucagon compared with 1 mg intramuscular glucagon | Within 30 minutes, glucose reached at least 70 mg/dL or rose at least 20 mg/dL from its lowest level without additional glucose-raising treatment at 74 of 75 nasal visits and all 75 intramuscular visits. For visits where the lowest glucose level was below 50 mg/dL, mean time to that threshold was 16 minutes for 58 nasal visits and 13 minutes for 44 intramuscular visits. | The study measured blood glucose response under supervision after hypoglycemia was induced with insulin. | Strong for the tested adult study conditions |
| BAQSIMI and GVOKE product labels | People with diabetes in each product's labeled age range | US prescribing information summarizing clinical studies | Nasal BAQSIMI and subcutaneous GVOKE rescue products | The labels specify severe hypoglycemia indications, administration, emergency assistance, contraindications, and product-specific safety. | The products have different routes and age thresholds. A label for one formulation does not establish instructions for another. | Strong for product-specific labeled use |
Cautions
Safety and unknowns
- Nausea and vomiting can occur. Nasal BAQSIMI can also cause nasal, throat, or eye irritation. Product-specific adverse effects are listed in each label.
- These rescue products are contraindicated in people with pheochromocytoma, insulinoma, or prior hypersensitivity to glucagon or their ingredients. Glucagon can cause a marked blood pressure rise in pheochromocytoma or hypoglycemia from insulin release in insulinoma.
- Inadequate liver glycogen can limit the glucose response. The labels cite starvation, adrenal insufficiency, and chronic hypoglycemia as settings in which stores may be insufficient.
- Intravenous diagnostic glucagon has additional precautions, including transient increases in blood pressure and heart rate in patients with cardiac disease and hyperglycemia in patients with diabetes. GVOKE VialDx is also contraindicated in people with glucagonoma.
Product quality
Product identity and quality
Rescue products are supplied as specific devices or kits. Their storage, preparation, dose, and administration instructions are not interchangeable with the diagnostic vial or another route.
Correct product
A rescue product must match the prescribed route and the person's labeled age or weight category.
Device and instructions
Caregivers need the prescribed product's instructions and should know how it is supplied before an emergency.
Storage
Follow the product's storage and expiration information so the rescue device is available when needed.
Mechanism
How it is proposed to work
Glucagon signals the liver to release stored glucose. This can raise blood sugar when enough liver glycogen is available.
Glucagon activates hepatic glucagon receptors and promotes glycogen breakdown. Depleted liver stores can make the rescue response unreliable.
Glucagon also inhibits gastrointestinal movement, which is the basis for a separately labeled diagnostic use during radiologic examinations.
FAQ
Common questions
What is glucagon rescue used for?
Specified glucagon products treat severe hypoglycemia in people with diabetes. Call for emergency help immediately after giving a rescue dose, as the product label directs.
Are nasal and injectable glucagon doses interchangeable?
No. BAQSIMI and GVOKE have different routes and product-specific labeled doses. Follow the prescribed product and its instructions.
Can glucagon fail to raise glucose?
Yes. Rescue glucagon depends on adequate liver glycogen. The labels warn that people with depleted stores, including in starvation or adrenal insufficiency, may not respond adequately.
Details
Technical details
Sources
References
- 1.
DailyMed. BAQSIMI prescribing information
Official US label for nasal glucagon, including the age range, emergency response, and safety information.
- 2.
DailyMed. GVOKE and GVOKE VialDx prescribing information
Official US label distinguishing subcutaneous rescue presentations from the intravenous diagnostic product.
- 3.
doi:10.2337/dc15-1498 PMID:26681725
Controlled comparison of nasal and intramuscular glucagon after insulin-induced hypoglycemia.
- 4.
doi:10.2337/dc15-1498 PMID:26681725
Full trial report defines the efficacy and safety populations, response endpoint, and subgroup response times.