Gvoke Hypopen 1mg/0.2ml 2 Auto Inj
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 Hypopen is an emergency medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes. It comes as an easy-to-use autoinjector that can be given by a caregiver, family member, or friend when someone is unable to take sugar by mouth.
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.
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. Once you are able to safely eat or drink, consume 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.
Precautions and Warnings
Do not use this medication if the solution appears cloudy, is leaking, or contains particles. The medication should be colorless to faint yellow; do not use it if the color has changed. 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 and 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 this medication as directed and discard any expired medication. Obtain a refill before the expiration date if a dose is needed.
Missed Dose
This medication is taken as needed. Do not take 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.
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. Once you are able to safely eat or drink, consume 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.
Precautions and Warnings
Do not use this medication if the solution appears cloudy, is leaking, or contains particles. The medication should be colorless to faint yellow; do not use it if the color has changed. 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 and 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 this medication as directed and discard any expired medication. Obtain a refill before the expiration date if a dose is needed.
Missed Dose
This medication is taken as needed. Do not take more frequently than directed by your doctor.
Lifestyle & Tips
- Always carry Gvoke Hypopen with you if you are at risk for severe hypoglycemia.
- Educate family members, friends, and caregivers on how and when to administer Gvoke Hypopen.
- Ensure you have a medical identification (e.g., bracelet, necklace) indicating your diabetes and need for glucagon.
- After administration and recovery, 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 recurrence of hypoglycemia.
- 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 into the lower abdomen, outer thigh, or outer upper arm.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
severe_hypoglycemia:
Administer 1 mg (0.2 mL) subcutaneously. If there has been no response after 15 minutes, a second dose may be administered while awaiting emergency medical assistance.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For pediatric patients weighing âĨ45 kg: 1 mg (0.2 mL) subcutaneously. For pediatric patients weighing <45 kg, a 0.5 mg (0.1 mL) dose is available in a separate Gvoke Hypopen product.
Adolescent:
For pediatric patients weighing âĨ45 kg: 1 mg (0.2 mL) subcutaneously.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Dialysis:
No specific recommendations; use as needed for acute severe hypoglycemia.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Confidence:
Medium
Pharmacology
Mechanism of Action
Glucagon 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 smooth muscle, particularly in the gastrointestinal tract.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified for SC, but rapid absorption.
Tmax:
Approximately 10-15 minutes after subcutaneous administration.
FoodEffect:
Not applicable, used for acute hypoglycemia.
Distribution:
Vd:
Not widely reported, but rapidly distributed.
ProteinBinding:
Not significantly protein bound.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 8-18 minutes.
Clearance:
High clearance rate due to rapid metabolism.
ExcretionRoute:
Metabolites excreted via urine.
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Within 10 minutes (increase in blood glucose).
PeakEffect:
Approximately 30 minutes.
DurationOfAction:
Approximately 60-90 minutes, depending on hepatic glycogen stores.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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
+ Fainting
+ 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Irritation at the injection site
Feeling tired or weak
Pale skin
Diarrhea
Upset stomach
Vomiting
* Headache
This is not a comprehensive list of all possible 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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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
+ Fainting
+ 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Irritation at the injection site
Feeling tired or weak
Pale skin
Diarrhea
Upset stomach
Vomiting
* Headache
This is not a comprehensive list of all possible 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:
- Severe confusion or disorientation
- Loss of consciousness (passing out)
- Seizures
- 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 symptoms you experienced.
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 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 (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 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 symptoms you experienced.
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 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 (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 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 monitor your condition effectively, follow your doctor's instructions for checking your blood sugar levels.
After taking this drug, 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 medication can cause low blood sugar, particularly in individuals with certain types of pancreas 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 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 are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
To monitor your condition effectively, follow your doctor's instructions for checking your blood sugar levels.
After taking this drug, 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 medication can cause low blood sugar, particularly in individuals with certain types of pancreas 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 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 are 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 levels)
- Hypotension (low blood pressure)
What to Do:
Seek immediate medical attention. Treatment is supportive and may include intravenous fluids and potassium supplementation if hypokalemia is severe. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Beta-blockers: May blunt the hyperglycemic action of glucagon and increase the risk of rebound hypoglycemia.
- Indomethacin: May reduce the hyperglycemic effect of glucagon.
Moderate Interactions
- Warfarin: Glucagon may potentiate the anticoagulant effect of warfarin. Monitor INR/PT.
Monitoring
Baseline Monitoring
Blood Glucose
Rationale: To confirm severe hypoglycemia prior to administration.
Timing: Immediately prior to administration if possible, or based on symptoms.
Routine Monitoring
Blood Glucose
Frequency: 15-30 minutes after administration, then periodically until stable.
Target: Above 70 mg/dL (3.9 mmol/L)
Action Threshold: If blood glucose does not rise or symptoms persist after 15 minutes, a second dose may be administered and emergency medical assistance should be sought.
Patient's Level of Consciousness
Frequency: Continuously until recovery.
Target: Return to normal alertness.
Action Threshold: If no improvement, seek emergency medical assistance.
Symptom Monitoring
- Resolution of severe hypoglycemia symptoms (e.g., confusion, disorientation, loss of consciousness, seizures, severe weakness, sweating, pallor, tremors).
- Nausea and vomiting (common side effects).
Special Patient Groups
Pregnancy
Glucagon is a naturally occurring hormone. Use in pregnancy for severe hypoglycemia is generally considered acceptable when the benefits outweigh the potential risks, as untreated severe hypoglycemia poses a greater risk to both mother and fetus. Limited human data suggest no increased risk of major birth defects or miscarriage.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified.
Second Trimester:
No specific increased risk identified.
Third Trimester:
No specific increased risk identified.
Lactation
Glucagon is a peptide hormone and is rapidly degraded in the gastrointestinal tract, making infant exposure through breast milk unlikely. It is considered compatible with breastfeeding.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Dosing is weight-based. For patients weighing âĨ45 kg, the 1 mg dose is appropriate. For patients weighing <45 kg, a 0.5 mg dose (available in a separate Gvoke Hypopen product) should be used. Safety and effectiveness in pediatric patients weighing less than 45 kg have been established for the 0.5 mg dose.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustment is required based on age alone, but monitor for underlying comorbidities.
Clinical Information
Clinical Pearls
- Gvoke Hypopen is designed for ease of use by non-medical personnel in an emergency situation.
- Always ensure the patient has access to a source of fast-acting carbohydrates (e.g., glucose tablets, juice) to consume once they are awake and able to swallow after glucagon administration.
- It is crucial to contact emergency medical services (e.g., 911) after administering glucagon, especially if the patient does not respond or if the cause of hypoglycemia is unclear.
- Check the expiration date regularly and replace expired devices.
- Store at room temperature (20°C to 25°C; 68°F to 77°F). Do not freeze.
Alternative Therapies
- Traditional Glucagon for Injection (powder for reconstitution)
- Baqsimi (intranasal glucagon)
- Zegalogue (dasiglucagon, pre-filled syringe or autoinjector)
- Intravenous Dextrose (administered by healthcare professionals in a medical setting)
Cost & Coverage
Average Cost:
Typically $250-$350 per 2-pack per 2-pack autoinjectors
Insurance Coverage:
Often Tier 2 or Tier 3, may require prior authorization.
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, so it's a good idea to check with your pharmacist for more information. 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and appropriate care.