Gvoke Hypopen 0.5mg/0.1ml 2 Aut Inj
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 Hypopen contains glucagon, a hormone that quickly raises blood sugar levels when they get dangerously low (severe hypoglycemia). It's an emergency medicine used when someone with diabetes is unconscious or 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.
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 or drinks, eat or drink a product containing sugar, such as fruit juice, and also have a longer-acting sugar source, 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 should be colorless to faint yellow; do not use if the solution changes color.
Avoid injecting the medication through clothing.
Each container is for single use only; use 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, 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 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 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 or drinks, eat or drink a product containing sugar, such as fruit juice, and also have a longer-acting sugar source, 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 should be colorless to faint yellow; do not use if the solution changes color.
Avoid injecting the medication through clothing.
Each container is for single use only; use 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, 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 more frequently than directed by your doctor.
Lifestyle & Tips
- After administering Gvoke Hypopen and the person regains consciousness, give them a fast-acting source of sugar (e.g., fruit juice, glucose gel) followed by a longer-acting carbohydrate source (e.g., crackers, sandwich) to prevent blood sugar from dropping again.
- Always have Gvoke Hypopen readily available and ensure family members or caregivers know how and when to use it.
- Check the expiration date regularly and replace expired pens.
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 mg (0.1 mL) administered subcutaneously or intramuscularly as a single dose
Dose Range:
0.5 - 0.5 mg
Condition-Specific Dosing:
severe_hypoglycemia:
Administer 0.5 mg (0.1 mL) as a single dose. If the patient does not respond after 15 minutes, a second dose may be administered while awaiting emergency medical assistance.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for Gvoke Hypopen 0.5mg. For patients weighing <45 kg, a 0.5 mg dose is typically used with other glucagon formulations.
Child:
For patients weighing <45 kg: 0.5 mg (0.1 mL) administered subcutaneously or intramuscularly as a single dose. If the patient does not respond after 15 minutes, a second dose may be administered while awaiting emergency medical assistance.
Adolescent:
For patients weighing <45 kg: 0.5 mg (0.1 mL) administered subcutaneously or intramuscularly as a single dose. For patients weighing âĨ45 kg: 1 mg (0.2 mL) administered subcutaneously or intramuscularly as a single dose (Note: Gvoke Hypopen 0.5mg is for patients <45kg or when 0.5mg is sufficient).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for emergency use.
Moderate:
No adjustment needed for emergency use.
Severe:
No adjustment needed for emergency use.
Dialysis:
No adjustment needed for emergency use.
Hepatic Impairment:
Mild:
No adjustment needed for emergency use.
Moderate:
No adjustment needed for emergency use.
Severe:
No adjustment needed for emergency use.
Pharmacology
Mechanism of Action
Glucagon is a polypeptide hormone that increases blood glucose concentration by stimulating hepatic glycogenolysis (breakdown of glycogen to glucose) and gluconeogenesis (synthesis of glucose from non-carbohydrate sources). It also relaxes smooth muscle of the gastrointestinal tract.
Pharmacokinetics
Absorption:
Bioavailability:
High (when administered parenterally)
Tmax:
Approximately 15-20 minutes (subcutaneous/intramuscular)
FoodEffect:
Not applicable for emergency parenteral administration
Distribution:
Vd:
Not readily available for specific formulation, generally distributes widely
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 8-18 minutes
Clearance:
Rapid
ExcretionRoute:
Renal and hepatic
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
5-15 minutes
PeakEffect:
Approximately 30 minutes
DurationOfAction:
60-90 minutes
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 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
+ 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
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.
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 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
+ 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
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 or unresponsiveness
- Seizures
- Inability to swallow
- Severe 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. 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 (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 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 (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. Follow your doctor's instructions for monitoring your blood sugar levels.
To minimize the risk of accidents, avoid driving and other 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, 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, after taking this medication, 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 minimize the risk of accidents, avoid driving and other 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, 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, after taking this medication, 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)
What to Do:
If overdose is suspected, seek immediate medical attention. Management is supportive. Call 1-800-222-1222 (Poison Control) for further guidance.
Drug Interactions
Moderate 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)
- Warfarin (may enhance the anticoagulant effect of warfarin)
Monitoring
Baseline Monitoring
Blood Glucose
Rationale: To confirm severe hypoglycemia if possible, and to establish a baseline before treatment.
Timing: Prior to administration, if feasible and not delaying treatment.
Routine Monitoring
Blood Glucose
Frequency: Within 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 sufficiently or patient does not regain consciousness within 15 minutes, a second dose may be administered and emergency medical assistance should be sought.
Level of Consciousness
Frequency: Continuously after administration.
Target: Return to normal or near-normal consciousness.
Action Threshold: Lack of improvement or worsening consciousness requires immediate medical attention.
Symptom Monitoring
- Return of consciousness
- Resolution of severe hypoglycemia symptoms (e.g., seizures, unresponsiveness)
- Nausea/vomiting (potential side effect)
Special Patient Groups
Pregnancy
Glucagon is considered safe for use during pregnancy for the emergency treatment of severe hypoglycemia. Untreated severe hypoglycemia poses a greater risk to both mother and fetus than glucagon administration.
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 hormone and is rapidly metabolized. It is generally considered safe for use during lactation for the emergency treatment of severe hypoglycemia. Minimal transfer into breast milk is expected.
Infant Risk:
Low risk to breastfed infant.
Pediatric Use
Gvoke Hypopen 0.5mg is approved for pediatric patients weighing <45 kg. Dosing is weight-based. Ensure appropriate dose is administered. Safety and efficacy in neonates and infants have not been established for Gvoke Hypopen.
Geriatric Use
No specific dose adjustment is required for geriatric patients. Use with caution in patients with pheochromocytoma or insulinoma, as these conditions may be exacerbated by glucagon.
Clinical Information
Clinical Pearls
- Gvoke Hypopen is a ready-to-use, pre-filled auto-injector, simplifying administration in an emergency compared to traditional glucagon kits requiring reconstitution.
- Always call for emergency medical assistance (e.g., 911) after administering glucagon, even if the patient appears to recover, to ensure proper follow-up care.
- Ensure the patient eats a source of sugar and then a longer-acting carbohydrate after regaining consciousness to prevent recurrence of hypoglycemia.
- Educate family members, caregivers, and school personnel on proper administration technique and when to use Gvoke Hypopen.
- Glucagon is ineffective in patients with depleted liver glycogen stores (e.g., prolonged fasting, adrenal insufficiency, chronic hypoglycemia, alcohol-induced hypoglycemia).
Alternative Therapies
- Glucagon Emergency Kit (reconstitutable vial and syringe)
- Baqsimi (nasal glucagon)
- Zegalogue (dasiglucagon, subcutaneous auto-injector)
- Oral glucose (if patient is conscious and able to swallow)
Cost & Coverage
Average Cost:
Varies, typically $250-$350 per 2-pack auto-injector
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 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 information about the medication taken, the amount, and the time it happened.