Gvoke Hypopen 1mg/0.2ml 1 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 works by quickly raising your blood sugar levels. It comes as a pre-filled auto-injector that can be given by a caregiver or family member.
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 about using this medication, 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, and also have a longer-acting sugar product, like crackers with cheese or peanut butter, as advised by your doctor.
Important Safety Precautions
Do not use this medication if the solution appears cloudy, is leaking, or contains particles. The solution should be colorless to faintly yellow; do not use it if the color changes. Avoid injecting 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. If the medication expires, obtain a refill before it is needed.
Missed Dose
This medication is used 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 about using this medication, 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, and also have a longer-acting sugar product, like crackers with cheese or peanut butter, as advised by your doctor.
Important Safety Precautions
Do not use this medication if the solution appears cloudy, is leaking, or contains particles. The solution should be colorless to faintly yellow; do not use it if the color changes. Avoid injecting 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. If the medication expires, obtain a refill before it is needed.
Missed Dose
This medication is used as needed. Do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Always have Gvoke HypoPen readily available if you are at risk for severe hypoglycemia.
- Educate family members, friends, and caregivers on how and when to administer Gvoke HypoPen.
- After administering Gvoke HypoPen and when the person 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, bread) to prevent recurrence of hypoglycemia.
- Seek immediate medical attention after any severe hypoglycemic episode, even if glucagon was administered and effective.
Dosing & Administration
Adult Dosing
Standard Dose:
1 mg subcutaneous injection as a single dose
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
severeHypoglycemia:
1 mg subcutaneous injection. Administer immediately upon recognition of severe hypoglycemia. After the patient responds, administer supplemental carbohydrates to prevent recurrence of hypoglycemia.
Pediatric Dosing
Neonatal:
Not established
Infant:
0.5 mg subcutaneous injection for children < 2 years or < 45 kg
Child:
0.5 mg subcutaneous injection for children < 2 years or < 45 kg; 1 mg subcutaneous injection for children âĨ 2 years or âĨ 45 kg
Adolescent:
1 mg subcutaneous injection
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific recommendations; use as needed for severe hypoglycemia.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Glucagon 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 the smooth muscle of the gastrointestinal tract.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (administered subcutaneously, rapid absorption)
Tmax:
Approximately 10-15 minutes (for blood glucose increase)
FoodEffect:
Not applicable (used for acute hypoglycemia)
Distribution:
Vd:
Not available
ProteinBinding:
Not available
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3-6 minutes (plasma half-life)
Clearance:
Not available
ExcretionRoute:
Metabolites excreted via urine
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within 10 minutes (blood glucose increase)
PeakEffect:
Approximately 15-30 minutes (blood glucose increase)
DurationOfAction:
1-2 hours (blood glucose effect)
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
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, contact 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
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, contact 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:
- Symptoms of severe hypoglycemia: disorientation, confusion, slurred speech, unresponsiveness, seizures, unconsciousness.
- Side effects after administration: nausea, vomiting, headache, dizziness, temporary increase in heart rate, abdominal pain.
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 (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 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 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 (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 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.
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 engaging in activities that require alertness, like driving. Only resume these tasks when you feel fully alert, as this medication can cause low blood sugar, particularly in individuals with certain pancreas tumors (glucagonoma, 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, 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 engaging in activities that require alertness, like driving. Only resume these tasks when you feel fully alert, as this medication can cause low blood sugar, particularly in individuals with certain pancreas tumors (glucagonoma, 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, 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)
- Hypertension (high blood pressure)
- Tachycardia (fast heart rate)
What to Do:
Contact a poison control center or emergency medical services immediately. Call 1-800-222-1222. Treatment is supportive and symptomatic. Intravenous fluids and potassium supplementation may be necessary for hypokalemia.
Drug Interactions
Major Interactions
- Beta-blockers: May cause a transient increase in pulse and blood pressure when given with glucagon, possibly due to inhibition of glucagon's counter-regulatory effects on catecholamine release. Also, beta-blockers may blunt the hyperglycemic action of glucagon.
Moderate Interactions
- Indomethacin: May reduce the blood glucose-raising effect of glucagon, possibly by inhibiting prostaglandin synthesis.
- Warfarin: Glucagon may increase the anticoagulant effect of warfarin. Monitor INR/PT.
Monitoring
Baseline Monitoring
Blood Glucose
Rationale: To confirm hypoglycemia and establish baseline for response assessment.
Timing: Prior to administration, if possible, or immediately upon suspicion of severe hypoglycemia.
Routine Monitoring
Blood Glucose
Frequency: Within 15-30 minutes after administration, then periodically as needed.
Target: Return to euglycemia (e.g., >70 mg/dL)
Action Threshold: If blood glucose does not rise sufficiently, consider additional glucagon or IV dextrose if available and patient remains unresponsive.
Level of Consciousness
Frequency: Continuously until patient is fully awake and able to swallow.
Target: Alert and oriented
Action Threshold: If no improvement in consciousness, seek immediate medical attention.
Symptom Monitoring
- Symptoms of hypoglycemia (e.g., confusion, dizziness, sweating, tremor, weakness, blurred vision, seizures, unconsciousness)
- Symptoms of hyperglycemia (e.g., thirst, frequent urination, fatigue) after recovery, indicating need for carbohydrate intake.
Special Patient Groups
Pregnancy
Glucagon is generally considered safe for use during pregnancy when needed to treat severe hypoglycemia. Untreated severe hypoglycemia poses a greater risk to both the mother and fetus than glucagon administration.
Trimester-Specific Risks:
First Trimester:
No known specific risks; use if clinically indicated.
Second Trimester:
No known specific risks; use if clinically indicated.
Third Trimester:
No known specific risks; use if clinically indicated.
Lactation
Glucagon is considered compatible with breastfeeding. It is a peptide hormone that is rapidly degraded in the maternal gastrointestinal tract and is unlikely to be absorbed systemically by the infant. The amount transferred into breast milk is expected to be negligible.
Infant Risk:
Low risk to infant.
Pediatric Use
Gvoke HypoPen is approved for use in pediatric patients aged 2 years and older, or weighing 45 kg or more (1 mg dose). For children under 2 years or weighing less than 45 kg, a 0.5 mg dose is recommended. Dosing is weight-based for younger/smaller children. Safety and efficacy in neonates have not been established.
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. Elderly patients may be more susceptible to the cardiovascular effects of glucagon.
Clinical Information
Clinical Pearls
- Gvoke HypoPen is designed for ease of use in an emergency situation by a non-medical person. Ensure caregivers are trained on its proper administration.
- Always check the expiration date of the Gvoke HypoPen regularly and replace it before it expires.
- After administering glucagon, once the patient is conscious and able to swallow, it is crucial to provide oral carbohydrates to replenish glycogen stores and prevent rebound hypoglycemia.
- Glucagon is less effective in patients with depleted glycogen stores (e.g., prolonged fasting, adrenal insufficiency, chronic hypoglycemia, or alcohol-induced hypoglycemia). In such cases, intravenous glucose may be necessary.
- Patients with pheochromocytoma or insulinoma should not receive glucagon due to the risk of severe hypertension or paradoxical hypoglycemia, respectively.
Alternative Therapies
- Traditional injectable glucagon (e.g., Glucagen, Glucagen HypoKit)
- Nasal glucagon (Baqsimi)
- Intravenous dextrose (for healthcare professional administration)
Cost & Coverage
Average Cost:
$250 - $350 per 1 mg/0.2 mL auto-injector
Insurance Coverage:
Tier 2 or 3 (Brand-name prescription drug)
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 this 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 occurred.