Gvoke 1mg/0.2ml Pfs ( 1 Syringe)
It is used to treat low blood sugar.
Drug Class
Antihypoglycemic Agent
Pharmacologic Class
Pancreatic Hormone; Glycogenolytic Agent
Pregnancy Category
Category B
FDA Approved
Sep 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gvoke is a 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 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-containing product available, like crackers with cheese or peanut butter. Adhere to your doctor's specific instructions.
Important Administration Guidelines
Do not use the 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 changes.
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 and other sharp objects in a designated 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.
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 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-containing product available, like crackers with cheese or peanut butter. Adhere to your doctor's specific instructions.
Important Administration Guidelines
Do not use the 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 changes.
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 and other sharp objects in a designated 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.
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 you are at risk for severe hypoglycemia.
- Inform family members, friends, or caregivers how and when to administer Gvoke.
- After Gvoke is given and you are awake and able to swallow, eat a fast-acting source of sugar (e.g., fruit juice, glucose tablets) followed by a long-acting carbohydrate (e.g., crackers, sandwich) to prevent blood sugar from dropping again.
- Contact your healthcare provider immediately after a severe hypoglycemic event to review your diabetes management plan.
Dosing & Administration
Adult Dosing
Standard Dose:
1 mg (0.2 mL) administered subcutaneously
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
severeHypoglycemia:
1 mg (0.2 mL) administered subcutaneously into the lower abdomen, outer thigh, or outer upper arm. Administer a second dose if blood glucose remains low after 15 minutes.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for Gvoke. For children 2 years and older or weighing less than 45 kg, the dose is 0.5 mg (0.1 mL).
Child:
For children 2 years and older or weighing less than 45 kg: 0.5 mg (0.1 mL) subcutaneously. For children weighing 45 kg or more: 1 mg (0.2 mL) subcutaneously.
Adolescent:
For adolescents weighing 45 kg or more: 1 mg (0.2 mL) subcutaneously.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but caution is advised as glucagon's effect may be diminished in patients with severe renal impairment due to depleted glycogen stores.
Dialysis:
Considerations: No specific dose adjustment recommended. Monitor blood glucose closely.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but caution is advised as glucagon's effect may be diminished in patients with severe hepatic impairment due to depleted glycogen stores.
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 has a relaxant effect on the smooth muscle of the gastrointestinal tract.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (administered parenterally)
Tmax:
Approximately 10-15 minutes (subcutaneous)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 0.2 L/kg
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 8-18 minutes (plasma half-life)
Clearance:
Approximately 13.5 mL/kg/min
ExcretionRoute:
Metabolites excreted via urine
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within 10-15 minutes (subcutaneous)
PeakEffect:
Approximately 30 minutes
DurationOfAction:
Approximately 60-90 minutes, depending on glycogen stores
Safety & Warnings
Side Effects
Serious 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
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 symptoms that bother you or do not go away, contact your doctor:
Irritation at the injection site
Fatigue or weakness
Pale skin
Diarrhea
Upset stomach
Vomiting
* Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. 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
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 symptoms that bother you or do not go away, contact your doctor:
Irritation at the injection site
Fatigue or weakness
Pale skin
Diarrhea
Upset stomach
Vomiting
* Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. 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
- Seizures
- Inability to eat or drink
- Extreme confusion or disorientation
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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have been diagnosed with an adrenal gland tumor known as pheochromocytoma.
If you have certain types of pancreatic tumors, specifically 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 medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication in combination with your other treatments and health conditions. Never start, stop, or adjust 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have been diagnosed with an adrenal gland tumor known as pheochromocytoma.
If you have certain types of pancreatic tumors, specifically 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 medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication in combination with your other treatments and health conditions. Never start, stop, or adjust 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.
After taking this drug, wait until you have consumed a sugary 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 low blood sugar.
Patients with certain types of pancreatic tumors, including glucagonoma or insulinoma, are at risk of developing low blood sugar while taking this medication. Severe low blood sugar 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, 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, wait until you have consumed a sugary 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 low blood sugar.
Patients with certain types of pancreatic tumors, including glucagonoma or insulinoma, are at risk of developing low blood sugar while taking this medication. Severe low blood sugar 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, 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
- Hypokalemia (low potassium)
- Hypertension (high blood pressure)
- Tachycardia (fast heart rate)
What to Do:
If overdose is suspected, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and may include intravenous fluids and potassium supplementation if hypokalemia is severe.
Drug Interactions
Moderate Interactions
- Beta-blockers
- Indomethacin
- Warfarin
Monitoring
Baseline Monitoring
Blood Glucose
Rationale: To confirm severe hypoglycemia before administration.
Timing: Immediately prior to administration if possible, or based on symptoms.
Routine Monitoring
Blood Glucose
Frequency: 15 minutes after administration, then periodically until stable and patient is fully recovered.
Target: Above 70 mg/dL (3.9 mmol/L)
Action Threshold: If blood glucose remains low after 15 minutes, a second dose may be administered. Once conscious, provide oral carbohydrates to prevent recurrence of hypoglycemia.
Patient's Level of Consciousness
Frequency: Continuously until fully recovered.
Target: Alert and oriented
Action Threshold: If no response within 15 minutes, seek immediate medical attention.
Symptom Monitoring
- Dizziness
- Confusion
- Irritability
- Sweating
- Tremors
- Weakness
- Blurred vision
- Seizures
- Loss of consciousness
Special Patient Groups
Pregnancy
Glucagon is generally considered safe for use during pregnancy to treat severe hypoglycemia. The benefits of treating severe hypoglycemia outweigh any potential risks to the fetus.
Trimester-Specific Risks:
First Trimester:
No known increased risk of major birth defects.
Second Trimester:
No known increased risk.
Third Trimester:
No known increased risk.
Lactation
Glucagon is considered compatible with breastfeeding. It is a naturally occurring hormone and is rapidly metabolized. Minimal amounts are expected to be transferred into breast milk, and adverse effects on the breastfed infant are not anticipated.
Infant Risk:
Low risk
Pediatric Use
Gvoke is approved for use in pediatric patients 2 years of age and older. Dosing is weight-based for children under 45 kg. Safety and effectiveness in pediatric patients younger than 2 years of age have not been established.
Geriatric Use
No specific dose adjustment is required for geriatric patients. However, elderly patients may have reduced glycogen stores, which could diminish the hyperglycemic response to glucagon. Monitor blood glucose closely.
Clinical Information
Clinical Pearls
- Gvoke is a ready-to-use liquid glucagon, eliminating the need for reconstitution, which can save critical time during a severe hypoglycemic event.
- Ensure proper training for patients and caregivers on how to administer Gvoke, including the correct injection site and technique.
- Always check the expiration date of the Gvoke syringe regularly and replace it before it expires.
- After administering Gvoke, turn the patient on their side to prevent aspiration in case of vomiting.
- Even after glucagon administration, it is crucial to follow up with oral carbohydrates once the patient is conscious and able to swallow to replenish glycogen stores and prevent rebound hypoglycemia.
Alternative Therapies
- Glucagon for injection (powder for reconstitution, e.g., GlucaGen)
- Baqsimi (intranasal glucagon)
- Oral glucose (for mild to moderate hypoglycemia, not severe)
- Intravenous dextrose (administered by healthcare professionals)
Cost & Coverage
Average Cost:
Approximately $250 - $350 per 1 mg/0.2 mL pre-filled syringe
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. 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 details about the medication taken, the amount, and the time it happened.