Gvoke 0.5mg/0.1ml 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 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 come with this medication. If you have any questions or concerns, consult your doctor or pharmacist.
Important Administration Instructions
This medication may need to be administered by someone else in an emergency situation. Ensure that others are aware of the medication's storage location and how to administer it if needed. After using this medication, seek medical attention immediately. If there is no response after 15 minutes, a second dose may be administered as directed by your doctor.
Post-Administration Care
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-containing product, like crackers with cheese or peanut butter, as directed by your doctor.
Precautions and Contraindications
Do not use this medication if the solution appears cloudy, is leaking, or contains particles. The medication should be colorless to faintly yellow; do not use it if the color has changed. Avoid injecting the medication through clothing. Each container is for single use only and should be used immediately after opening. Discard any remaining medication and dispose of the container after administration.
Needle Disposal
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Expiration and Refills
If this medication expires, obtain a refill before it is needed.
Storage and Disposal
For all products, follow proper storage and disposal procedures.
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 come with this medication. If you have any questions or concerns, consult your doctor or pharmacist.
Important Administration Instructions
This medication may need to be administered by someone else in an emergency situation. Ensure that others are aware of the medication's storage location and how to administer it if needed. After using this medication, seek medical attention immediately. If there is no response after 15 minutes, a second dose may be administered as directed by your doctor.
Post-Administration Care
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-containing product, like crackers with cheese or peanut butter, as directed by your doctor.
Precautions and Contraindications
Do not use this medication if the solution appears cloudy, is leaking, or contains particles. The medication should be colorless to faintly yellow; do not use it if the color has changed. Avoid injecting the medication through clothing. Each container is for single use only and should be used immediately after opening. Discard any remaining medication and dispose of the container after administration.
Needle Disposal
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Expiration and Refills
If this medication expires, obtain a refill before it is needed.
Storage and Disposal
For all products, follow proper storage and disposal procedures.
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 you are at risk for severe hypoglycemia.
- Inform family members, caregivers, and close contacts how to administer Gvoke and when to call for emergency medical help.
- After Gvoke is administered and the person is awake and able to swallow, give them a fast-acting source of sugar (e.g., fruit juice, glucose gel) followed by a long-acting carbohydrate (e.g., crackers, sandwich) to prevent blood sugar from dropping again.
- Seek immediate medical attention after any severe hypoglycemic episode, even if Gvoke was administered successfully.
- Wear a medical alert identification (e.g., bracelet, necklace) indicating you have diabetes.
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable for this specific product (0.5mg/0.1ml PFS) which is for pediatric patients <45kg. For adults and pediatric patients weighing 45 kg or more, the standard Gvoke dose is 1 mg (0.2 mL) administered subcutaneously.
Condition-Specific Dosing:
severeHypoglycemia:
Not applicable for this specific product (0.5mg/0.1ml PFS). For adults and pediatric patients weighing 45 kg or more, administer 1 mg (0.2 mL) subcutaneously.
Pediatric Dosing
Neonatal:
Not established
Infant:
For pediatric patients weighing less than 45 kg: 0.5 mg (0.1 mL) administered subcutaneously.
Child:
For pediatric patients weighing less than 45 kg: 0.5 mg (0.1 mL) administered subcutaneously. For pediatric patients weighing 45 kg or more: 1 mg (0.2 mL) administered subcutaneously.
Adolescent:
For pediatric patients weighing less than 45 kg: 0.5 mg (0.1 mL) administered subcutaneously. For pediatric patients weighing 45 kg or more: 1 mg (0.2 mL) administered subcutaneously.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended for acute use.
Moderate:
No specific dose adjustment recommended for acute use.
Severe:
No specific dose adjustment recommended for acute use.
Dialysis:
No specific dose adjustment recommended for acute use.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended for acute use.
Moderate:
No specific dose adjustment recommended for acute use.
Severe:
No specific dose adjustment recommended for acute use.
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 (the breakdown of glycogen to glucose) and gluconeogenesis (the synthesis of glucose from non-carbohydrate sources). It also inhibits glycogen synthesis. Glucagon exerts its effect by binding to specific glucagon receptors on hepatocytes, leading to activation of adenylate cyclase and increased cyclic AMP (cAMP) production, which promotes the release of glucose from the liver.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (subcutaneous administration)
Tmax:
Approximately 15-20 minutes (subcutaneous)
FoodEffect:
Not applicable (used for acute hypoglycemia)
Distribution:
Vd:
Not available
ProteinBinding:
Not available
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 8-18 minutes
Clearance:
Not available
ExcretionRoute:
Primarily renal
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within 10-15 minutes
PeakEffect:
Approximately 30 minutes
DurationOfAction:
Approximately 60-90 minutes
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:
- Unconsciousness or unresponsiveness
- Seizures or convulsions
- Inability to eat or drink
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 that occurred.
If you have been diagnosed with an adrenal gland tumor known as pheochromocytoma.
If you have certain types of pancreas tumors, specifically glucagonoma or insulinoma.
If you have a weak adrenal gland, have recently 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 medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 that occurred.
If you have been diagnosed with an adrenal gland tumor known as pheochromocytoma.
If you have certain types of pancreas tumors, specifically glucagonoma or insulinoma.
If you have a weak adrenal gland, have recently 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 medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To manage your condition effectively, follow your doctor's instructions for monitoring your blood sugar levels.
After taking this medication, wait until you have consumed a sugar-containing product, such as a regular soft drink or fruit juice, before driving or engaging in any activities that require alertness. Only resume these tasks when you feel fully alert, as this medication can cause drowsiness.
Be aware that this drug may cause low blood sugar (hypoglycemia) in individuals with certain types of pancreatic tumors, including glucagonoma and insulinoma. Severe hypoglycemia can lead to serious complications, such as seizures, confusion, loss of consciousness, and even death. If you experience any symptoms of low blood sugar, including dizziness, headache, drowsiness, weakness, tremors, 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.
To manage your condition effectively, follow your doctor's instructions for monitoring your blood sugar levels.
After taking this medication, wait until you have consumed a sugar-containing product, such as a regular soft drink or fruit juice, before driving or engaging in any activities that require alertness. Only resume these tasks when you feel fully alert, as this medication can cause drowsiness.
Be aware that this drug may cause low blood sugar (hypoglycemia) in individuals with certain types of pancreatic tumors, including glucagonoma and insulinoma. Severe hypoglycemia can lead to serious complications, such as seizures, confusion, loss of consciousness, and even death. If you experience any symptoms of low blood sugar, including dizziness, headache, drowsiness, weakness, tremors, 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
- Hypokalemia (low potassium)
- Hypotension (low blood pressure)
- Tachycardia (fast heart rate)
What to Do:
If overdose is suspected, seek immediate medical attention. Management is supportive and may include fluid and electrolyte replacement, particularly potassium. For severe symptoms, call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Beta-blockers
- Indomethacin
- Warfarin
Monitoring
Baseline Monitoring
Blood Glucose
Rationale: To confirm severe hypoglycemia before administration, if possible, and to establish baseline.
Timing: Prior to administration (if feasible)
Routine Monitoring
Blood Glucose
Frequency: Every 15-30 minutes after administration until stable and above 70 mg/dL (3.9 mmol/L)
Target: >70 mg/dL (3.9 mmol/L)
Action Threshold: If blood glucose does not respond adequately, consider repeat dose or IV dextrose.
Level of Consciousness
Frequency: Continuously until patient is alert and able to consume oral carbohydrates.
Target: Alert and oriented
Action Threshold: If no improvement in consciousness, seek immediate medical attention.
Symptom Monitoring
- Return of consciousness
- Resolution of seizure activity
- Ability to swallow and consume oral carbohydrates
- Nausea/vomiting (potential side effect)
Special Patient Groups
Pregnancy
Glucagon is considered the drug of choice for severe hypoglycemia in pregnant women. While Gvoke's specific label states 'no data on the use of Gvoke in pregnant women to inform a drug-associated risk for major birth defects and miscarriage,' the benefits of treating severe hypoglycemia outweigh potential risks. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No known specific risks, but severe hypoglycemia itself poses risks to both mother and fetus.
Second Trimester:
No known specific risks.
Third Trimester:
No known specific risks.
Lactation
No data on the presence of Gvoke in human milk, the effects on the breastfed infant, or the effects on milk production. However, glucagon is a peptide and is expected to be degraded in the infant's gastrointestinal tract, making systemic exposure unlikely. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Gvoke is approved for pediatric patients with diabetes aged 2 years and older. Dosing is weight-based: 0.5 mg (0.1 mL) for patients weighing less than 45 kg, and 1 mg (0.2 mL) for patients weighing 45 kg or more. Safety and effectiveness in pediatric patients younger than 2 years of age have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustment is required. However, elderly patients may be more sensitive to the effects of glucagon, and underlying cardiovascular conditions should be considered.
Clinical Information
Clinical Pearls
- Always turn an unconscious patient on their side after administering glucagon to prevent aspiration in case of vomiting.
- Ensure the patient consumes oral carbohydrates (fast-acting, then long-acting) once they regain consciousness and can swallow, to replenish glycogen stores and prevent recurrent hypoglycemia.
- Gvoke is for subcutaneous injection only. Do not inject intravenously or intramuscularly.
- Check the expiration date regularly and replace expired product.
- Store Gvoke at room temperature (20°C to 25°C; 68°F to 77°F). Do not freeze.
Alternative Therapies
- Baqsimi (nasal glucagon)
- Zegalogue (dasiglucagon injection)
- Glucagon for Injection (reconstituted powder for IM/SC/IV use)
- Intravenous Dextrose (for healthcare professional administration)
Cost & Coverage
Average Cost:
$280 - $350 per 2-pack of 0.5mg/0.1ml pre-filled syringes
Insurance Coverage:
Tier 2 or Tier 3 (Specialty drug)
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 this medication, don't hesitate to 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred, as this will help healthcare professionals provide the best possible care.