Gvoke 1mg/0.2ml Pfs (2 Syringes)
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 emergency medicine used to quickly raise blood sugar levels when they become dangerously low (severe hypoglycemia) in people with diabetes. It works by telling your liver to release stored sugar into your bloodstream.
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 administration 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, and also have a longer-acting sugar product, like crackers with cheese or peanut butter, as advised by your doctor.
Important Administration Guidelines
Do not use the medication if the solution appears cloudy, is leaking, or contains particles.
The medication is colorless to faint yellow; do not use it if the solution changes color.
Avoid injecting the medication through clothing.
Each container is 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; do not reuse needles or other items. When the box is full, follow local regulations for disposal.
If you have any questions or concerns, consult with your doctor or pharmacist.
Storage and Disposal
Store the medication according to the manufacturer's instructions.
If the medication expires, obtain a refill before it is needed.
Missed Dose
This medication is taken as needed. Do not take it more frequently than directed by your doctor.
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 administration 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, and also have a longer-acting sugar product, like crackers with cheese or peanut butter, as advised by your doctor.
Important Administration Guidelines
Do not use the medication if the solution appears cloudy, is leaking, or contains particles.
The medication is colorless to faint yellow; do not use it if the solution changes color.
Avoid injecting the medication through clothing.
Each container is 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; do not reuse needles or other items. When the box is full, follow local regulations for disposal.
If you have any questions or concerns, consult with your doctor or pharmacist.
Storage and Disposal
Store the medication according to the manufacturer's instructions.
If the medication expires, obtain a refill before it is needed.
Missed Dose
This medication is taken as needed. Do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Always carry Gvoke with you if prescribed.
- Educate family members, friends, and caregivers on how and when to administer Gvoke.
- After administering Gvoke and once the patient is awake and able to swallow, give them a fast-acting source of sugar (e.g., fruit juice, glucose tablets) followed by a longer-acting carbohydrate (e.g., crackers, sandwich).
- Always call for emergency medical help (e.g., 911) immediately after administering Gvoke, even if the patient recovers.
- Check the expiration date of your Gvoke regularly and replace it before it expires.
- Store Gvoke at room temperature (20°C to 25°C; 68°F to 77°F) and protect from light. Do not freeze.
Dosing & Administration
Adult Dosing
Standard Dose:
1 mg (0.2 mL) administered subcutaneously or intramuscularly
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
severeHypoglycemia:
1 mg (0.2 mL) administered subcutaneously or intramuscularly
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (for Gvoke PFS, but general glucagon use is weight-based)
Child:
Patients weighing less than 45 kg: 0.5 mg (0.1 mL) subcutaneously or intramuscularly; Patients weighing 45 kg or more: 1 mg (0.2 mL) subcutaneously or intramuscularly
Adolescent:
Patients weighing less than 45 kg: 0.5 mg (0.1 mL) subcutaneously or intramuscularly; Patients weighing 45 kg or more: 1 mg (0.2 mL) subcutaneously or intramuscularly
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended
Moderate:
No specific dose adjustment recommended
Severe:
No specific dose adjustment recommended
Dialysis:
No specific considerations; primarily for acute, short-term use
Hepatic Impairment:
Mild:
No specific dose adjustment recommended
Moderate:
No specific dose adjustment recommended
Severe:
No specific dose adjustment recommended
Pharmacology
Mechanism of Action
Glucagon increases blood glucose concentration by stimulating hepatic glycogenolysis and gluconeogenesis. It binds to glucagon receptors on hepatocytes, activating adenylate cyclase, leading to increased cyclic AMP (cAMP) and activation of phosphorylase kinase, which promotes glycogen breakdown.
Pharmacokinetics
Absorption:
Bioavailability:
High (for IM/SC administration)
Tmax:
Approximately 10-15 minutes (subcutaneous/intramuscular)
FoodEffect:
Not applicable (administered for acute hypoglycemia, not with food)
Distribution:
Vd:
Not extensively distributed; relatively small volume of distribution
ProteinBinding:
Not highly protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 8-18 minutes
Clearance:
Rapid
ExcretionRoute:
Metabolic degradation
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Blood glucose rise typically within 10-15 minutes
PeakEffect:
Approximately 30 minutes
DurationOfAction:
1-2 hours (dependent on hepatic glycogen stores)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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
Skin reactions, such as:
+ Blisters
+ Scaly, red, itchy, or painful skin
+ Skin breakdown
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Irritation at the injection site
Fatigue or weakness
Pale skin
Diarrhea
Upset stomach
Vomiting
* Headache
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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
Skin reactions, such as:
+ Blisters
+ Scaly, red, itchy, or painful skin
+ Skin breakdown
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Irritation at the injection site
Fatigue or weakness
Pale skin
Diarrhea
Upset stomach
Vomiting
* Headache
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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:
- Nausea
- Vomiting
- Headache
- Dizziness
- Injection site reactions (pain, redness, swelling)
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 you experienced, including any symptoms.
If you have been diagnosed with an adrenal gland tumor known as pheochromocytoma.
If you have certain types of pancreatic tumors, including glucagonoma or insulinoma.
If you have a weakened adrenal gland, have experienced prolonged fasting or dehydration, or frequently have low blood sugar levels.
This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Please inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems
Your doctor will assess the safety of taking this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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 you experienced, including any symptoms.
If you have been diagnosed with an adrenal gland tumor known as pheochromocytoma.
If you have certain types of pancreatic tumors, including glucagonoma or insulinoma.
If you have a weakened adrenal gland, have experienced prolonged fasting or dehydration, or frequently have low blood sugar levels.
This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Please inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems
Your doctor will assess the safety of taking this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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.
To minimize the risk of accidents, avoid driving or engaging in activities that require alertness until you have consumed a sugary product, such as a regular soft drink or fruit juice, and feel fully alert. This precaution is crucial, as 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, including seizures, confusion, loss of consciousness, and even death.
If you experience symptoms of low blood sugar, such as dizziness, headache, drowsiness, weakness, tremors, rapid heartbeat, confusion, hunger, or sweating, seek medical attention immediately.
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.
To minimize the risk of accidents, avoid driving or engaging in activities that require alertness until you have consumed a sugary product, such as a regular soft drink or fruit juice, and feel fully alert. This precaution is crucial, as 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, including seizures, confusion, loss of consciousness, and even death.
If you experience symptoms of low blood sugar, such as dizziness, headache, drowsiness, weakness, tremors, rapid heartbeat, confusion, hunger, or sweating, seek medical attention immediately.
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
- Hypotension
- Hypokalemia (due to increased insulin release and cellular uptake of potassium)
What to Do:
Seek immediate medical attention. Treatment is supportive and may include intravenous fluids, electrolyte monitoring (especially potassium), and potassium replacement if needed. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Beta-blockers (may blunt hyperglycemic effect of glucagon and cause a paradoxical increase in blood pressure and pulse rate)
- Indomethacin (may inhibit glucagon's effect on blood glucose)
Moderate Interactions
- Warfarin (may potentiate the anticoagulant effect of warfarin)
Monitoring
Baseline Monitoring
Blood Glucose
Rationale: To confirm severe hypoglycemia if possible, though often administered empirically in emergency.
Timing: Prior to administration (if feasible and not delaying treatment)
Routine Monitoring
Blood Glucose
Frequency: Every 15-30 minutes after administration, then hourly until stable
Target: Above 70 mg/dL (3.9 mmol/L)
Action Threshold: If blood glucose does not rise or patient does not regain consciousness, consider repeat dose or alternative treatment (e.g., IV dextrose) and seek immediate medical attention.
Level of Consciousness
Frequency: Continuously until patient is fully awake and alert
Target: Alert and oriented
Action Threshold: If no improvement in consciousness, seek immediate medical attention.
Symptom Monitoring
- Nausea
- Vomiting
- Headache
- Dizziness
- Hypotension
- Hypokalemia (in overdose)
Special Patient Groups
Pregnancy
Glucagon is generally considered safe for use during pregnancy for the treatment of severe hypoglycemia. Human data from case reports and small studies have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The benefits of treating severe hypoglycemia in a pregnant woman outweigh any potential risks.
Trimester-Specific Risks:
First Trimester:
No increased risk observed.
Second Trimester:
No increased risk observed.
Third Trimester:
No increased risk observed.
Lactation
Glucagon is a peptide and is expected to be rapidly degraded in the infant's gastrointestinal tract if ingested. Systemic absorption by the mother is minimal, making infant exposure through breast milk unlikely. Therefore, breastfeeding is generally considered safe during glucagon use.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Gvoke is approved for use in pediatric patients aged 2 years and older. Dosing is weight-based (0.5 mg for <45 kg, 1 mg for âĨ45 kg). Safety and effectiveness have been established.
Geriatric Use
No specific dose adjustment is required for geriatric patients. Clinical studies of Gvoke did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, other reported clinical experience has not identified differences in responses between the elderly and younger patients. Use with caution in patients with pheochromocytoma or insulinoma.
Clinical Information
Clinical Pearls
- Gvoke is for emergency use only to treat severe hypoglycemia. It is not a substitute for daily insulin or other diabetes medications.
- Always ensure the patient consumes fast-acting carbohydrates followed by a longer-acting snack once they are conscious and able to swallow after glucagon administration.
- Instruct patients and caregivers to call emergency medical services (e.g., 911) immediately after administering Gvoke, even if the patient recovers.
- Glucagon requires adequate hepatic glycogen stores to be effective. It may be less effective in patients with prolonged fasting, adrenal insufficiency, chronic hypoglycemia, or alcohol-induced hypoglycemia.
- Do not use Gvoke if the solution is discolored or contains particulate matter.
Alternative Therapies
- Intravenous Dextrose (administered by healthcare professionals)
- Baqsimi (nasal glucagon powder)
- Zegalogue (dasiglucagon injection)
- Glucagon for injection (powder for reconstitution, various brands/generics)
Cost & Coverage
Average Cost:
Varies widely, typically high for emergency medications per 2 syringes
Insurance Coverage:
Tier 2 or 3 (varies by insurance plan)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet; consult your pharmacist for more information. If you have any questions or concerns about this medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.