Gvoke 0.5mg/0.1ml Pfs (1 Syringe)
It is used to treat low blood sugar.
Drug Class
Antihypoglycemic agent
Pharmacologic Class
Pancreatic hormone; Glycogenolytic agent
Pregnancy Category
Not available
FDA Approved
Sep 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gvoke is an injectable medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes. It works by telling your liver to release stored sugar into your bloodstream, quickly raising your blood sugar levels.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. It is essential to understand how to use this medication before an emergency situation arises. Carefully review the package insert and instructions for use that accompany this medication. If you have any questions or concerns, consult with your doctor or pharmacist.
In the event that someone else will be administering this medication, ensure they are aware of its storage location and the proper injection technique. After using this medication, seek medical attention immediately. If there is no response within 15 minutes, a second dose may be administered as directed by your doctor.
Once you are able to safely consume food and drinks, eat or drink a product containing sugar, such as fruit juice. You should also have a longer-acting sugar product available, like crackers with cheese or peanut butter. Adhere to your doctor's specific instructions.
Important Safety Precautions
Do not use this medication if the solution appears cloudy, is leaking, or contains particles. The solution should be colorless to faintly yellow; do not use it if the color changes. Avoid injecting the medication through clothing. Each container is intended for single use only; use it immediately after opening and discard any remaining solution after administration. Dispose of needles in a designated needle/sharp disposal box and do not reuse them. When the box is full, follow local regulations for proper disposal. If you have any questions, consult with your doctor or pharmacist.
Storage and Disposal
Store this medication according to the product's specific guidelines.
Missed Dose
This medication is taken as needed. Do not take it more frequently than directed by your doctor. If the medication is approaching its expiration date, obtain a refill before it is needed.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. It is essential to understand how to use this medication before an emergency situation arises. Carefully review the package insert and instructions for use that accompany this medication. If you have any questions or concerns, consult with your doctor or pharmacist.
In the event that someone else will be administering this medication, ensure they are aware of its storage location and the proper injection technique. After using this medication, seek medical attention immediately. If there is no response within 15 minutes, a second dose may be administered as directed by your doctor.
Once you are able to safely consume food and drinks, eat or drink a product containing sugar, such as fruit juice. You should also have a longer-acting sugar product available, like crackers with cheese or peanut butter. Adhere to your doctor's specific instructions.
Important Safety Precautions
Do not use this medication if the solution appears cloudy, is leaking, or contains particles. The solution should be colorless to faintly yellow; do not use it if the color changes. Avoid injecting the medication through clothing. Each container is intended for single use only; use it immediately after opening and discard any remaining solution after administration. Dispose of needles in a designated needle/sharp disposal box and do not reuse them. When the box is full, follow local regulations for proper disposal. If you have any questions, consult with your doctor or pharmacist.
Storage and Disposal
Store this medication according to the product's specific guidelines.
Missed Dose
This medication is taken as needed. Do not take it more frequently than directed by your doctor. If the medication is approaching its expiration date, obtain a refill before it is needed.
Lifestyle & Tips
- Always have Gvoke readily available if prescribed, especially when away from home.
- Inform family members, caregivers, or close contacts on how and when to administer Gvoke.
- After administering Gvoke and the person is awake and able to swallow, give them a fast-acting source of sugar (e.g., fruit juice, glucose tablets) followed by a long-acting carbohydrate (e.g., crackers, bread) to prevent blood sugar from dropping again.
- Seek emergency medical attention immediately after administering Gvoke, even if the person recovers, to determine the cause of severe hypoglycemia and prevent future episodes.
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 mg (0.1 mL) subcutaneously as a single dose
Dose Range:
0.5 - 0.5 mg
Condition-Specific Dosing:
severeHypoglycemia:
0.5 mg (0.1 mL) subcutaneously as a single dose. If no response after 15 minutes, a second dose may be administered while awaiting emergency medical assistance.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for this specific formulation (Gvoke 0.5mg/0.1ml is for patients weighing less than 45 kg, typically children).
Child:
For patients weighing less than 45 kg: 0.5 mg (0.1 mL) subcutaneously as a single dose. If no response after 15 minutes, a second dose may be administered while awaiting emergency medical assistance.
Adolescent:
For patients weighing less than 45 kg: 0.5 mg (0.1 mL) subcutaneously as a single dose. For patients weighing 45 kg or more, the 1 mg dose is typically used.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Dialysis:
No specific recommendations; glucagon is primarily metabolized by liver and kidney, but acute use for hypoglycemia typically does not require adjustment.
Hepatic Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Confidence:
Medium
Pharmacology
Mechanism of Action
Glucagon is a polypeptide hormone produced by the alpha cells of the pancreas. It increases blood glucose concentration by stimulating hepatic glycogenolysis (breakdown of glycogen to glucose) and gluconeogenesis (synthesis of glucose from non-carbohydrate sources). It also inhibits glycogen synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
High (when administered subcutaneously or intramuscularly)
Tmax:
Approximately 15-20 minutes (subcutaneous)
FoodEffect:
Not applicable (administered for acute hypoglycemia, not with food)
Distribution:
Vd:
Not widely reported for exogenous glucagon, but distributes rapidly to the liver.
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 8-18 minutes
Clearance:
High, rapid clearance from plasma
ExcretionRoute:
Metabolites excreted renally
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
5-15 minutes (increase in blood glucose)
PeakEffect:
Approximately 30 minutes
DurationOfAction:
1-2 hours (depending on hepatic glycogen stores)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Rapid heartbeat
Blisters
Scaly, red, itchy, or painful skin
Skin breakdown
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Irritation at the injection site
Feeling tired or weak
Pale skin
Diarrhea
Upset stomach
Vomiting
* Headache
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Rapid heartbeat
Blisters
Scaly, red, itchy, or painful skin
Skin breakdown
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Irritation at the injection site
Feeling tired or weak
Pale skin
Diarrhea
Upset stomach
Vomiting
* Headache
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unconsciousness or unresponsiveness due to low blood sugar
- Seizures due to low blood sugar
- Inability to eat or drink due to low blood sugar
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have been diagnosed with pheochromocytoma, a type of adrenal gland tumor.
If you have certain types of pancreas tumors, including glucagonoma or insulinoma.
If you have a weak adrenal gland, have experienced prolonged periods without food or water, or frequently have low blood sugar levels.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and other treatments. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have been diagnosed with pheochromocytoma, a type of adrenal gland tumor.
If you have certain types of pancreas tumors, including glucagonoma or insulinoma.
If you have a weak adrenal gland, have experienced prolonged periods without food or water, or frequently have low blood sugar levels.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and other treatments. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Follow your doctor's instructions for monitoring your blood sugar levels.
After taking this drug, do not engage in activities that require alertness, such as driving, until you have consumed a sugar-containing product like a regular soft drink or fruit juice, and you feel fully alert.
Be aware that this medication can cause low blood sugar, particularly in individuals with certain types of pancreatic tumors, including glucagonoma and insulinoma. Severe low blood sugar can lead to serious complications, such as seizures, confusion, loss of consciousness, and even death. If you experience symptoms of low blood sugar, including dizziness, headache, drowsiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating, seek immediate medical attention.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
After taking this drug, do not engage in activities that require alertness, such as driving, until you have consumed a sugar-containing product like a regular soft drink or fruit juice, and you feel fully alert.
Be aware that this medication can cause low blood sugar, particularly in individuals with certain types of pancreatic tumors, including glucagonoma and insulinoma. Severe low blood sugar can lead to serious complications, such as seizures, confusion, loss of consciousness, and even death. If you experience symptoms of low blood sugar, including dizziness, headache, drowsiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating, seek immediate medical attention.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Hypokalemia (low potassium)
- Transient increase in blood pressure and pulse rate
What to Do:
Contact a poison control center or emergency medical services immediately. Treatment is supportive. Intravenous fluids and electrolyte monitoring (especially potassium) may be necessary. For severe hypertension, alpha-adrenergic blocking agents may be considered. Call 1-800-222-1222 for poison control.
Drug Interactions
Major Interactions
- Beta-blockers (may cause a transient increase in blood pressure and pulse rate due to catecholamine release, especially in patients with pheochromocytoma)
- Indomethacin (may reduce the blood glucose-raising effect of glucagon)
Moderate Interactions
- Warfarin (glucagon may enhance the anticoagulant effect of warfarin, requiring careful monitoring of INR/PT)
Monitoring
Baseline Monitoring
Blood glucose level
Rationale: To confirm severe hypoglycemia before administration, if possible, and to establish baseline for post-treatment monitoring.
Timing: Prior to administration (if feasible and not delaying treatment)
Routine Monitoring
Blood glucose level
Frequency: Every 15-30 minutes initially, then as clinically indicated
Target: Return to normal range (e.g., >70 mg/dL)
Action Threshold: If blood glucose does not rise sufficiently or if symptoms persist after 15 minutes, consider a second dose or seek emergency medical attention.
Level of consciousness
Frequency: Continuously until patient is fully alert and able to consume oral carbohydrates
Target: Alert and oriented
Action Threshold: Persistent unresponsiveness or worsening mental status requires immediate medical intervention.
Symptom Monitoring
- Return of consciousness
- Resolution of seizure activity
- Improvement in signs of hypoglycemia (e.g., sweating, tremor, confusion, weakness)
Special Patient Groups
Pregnancy
Glucagon is generally considered safe for use in pregnancy for the treatment of severe hypoglycemia. It is a naturally occurring hormone and is not expected to cause fetal harm. Clinical experience with glucagon in pregnant women has not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Trimester-Specific Risks:
First Trimester:
No known increased risk.
Second Trimester:
No known increased risk.
Third Trimester:
No known increased risk.
Lactation
Glucagon is a naturally occurring peptide hormone. It is unlikely to be excreted in human milk in clinically significant amounts or to be orally absorbed by an infant. Therefore, it is generally considered safe for use during breastfeeding.
Infant Risk:
Low risk to breastfed infant.
Pediatric Use
Gvoke 0.5 mg/0.1 mL is specifically indicated for pediatric patients weighing less than 45 kg. Dosing is weight-based. Safety and effectiveness have been established in pediatric patients with diabetes aged 2 years and older. Not recommended for children under 2 years of age.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dose adjustment is generally not required based on age alone. However, elderly patients may have reduced hepatic glycogen stores, which could affect the response to glucagon.
Clinical Information
Clinical Pearls
- Gvoke is a ready-to-use pre-filled syringe, eliminating the need for reconstitution, which can be critical in an emergency.
- Ensure proper storage (room temperature, away from light) and check the expiration date regularly.
- Always call for emergency medical assistance after administering glucagon, even if the patient recovers, to ensure follow-up care and identify the cause of the severe hypoglycemia.
- After recovery, ensure the patient consumes oral carbohydrates to replenish glycogen stores and prevent recurrent hypoglycemia.
- Glucagon requires adequate hepatic glycogen stores to be effective. It may be less effective in states of starvation, adrenal insufficiency, or chronic hypoglycemia.
Alternative Therapies
- Dextrose intravenous (IV) injection (for healthcare settings)
- Other glucagon formulations (e.g., traditional glucagon emergency kits requiring reconstitution, Baqsimi nasal powder, Zegalogue auto-injector)
- Oral glucose (for mild to moderate hypoglycemia, not severe)
Cost & Coverage
Average Cost:
$250 - $350 per 1 syringe
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.