Insulin Degludec U100 Inj Vial 10ml
It is used to lower blood sugar in patients with high blood sugar (diabetes).
Drug Class
Antidiabetic agent
Pharmacologic Class
Insulin, long-acting analog
Pregnancy Category
Not available
FDA Approved
Sep 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Insulin degludec is a long-acting insulin that helps your body use sugar for energy. It works by slowly releasing insulin into your body over a long period, typically more than 24 hours, to help keep your blood sugar levels stable throughout the day and night. It is usually taken once a day.
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. For all patients taking this medication:
This medication is administered via injection into the fatty tissue under the skin, typically in the thigh, abdominal area, or upper arm.
If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before use, wash your hands thoroughly.
Rotate the injection site each time to avoid repeated use of the same area.
Avoid injecting into skin that is thickened, has pits or lumps, or is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Do not use the medication if the solution appears cloudy, is leaking, or contains particles, or if the solution has changed color.
Dispose of used needles and syringes in a designated sharps disposal container. Do not reuse needles or other materials. When the container is full, follow local regulations for disposal.
If you have any questions or concerns, consult your doctor or pharmacist.
Important Administration Guidelines
Do not draw the medication into a syringe and store it for future use.
Do not mix this insulin with other types of insulin in the same syringe.
Follow the diet and exercise plan recommended by your doctor.
This medication is not suitable for use in an insulin pump. If you have questions, consult your doctor.
Storage and Disposal
Store unopened pens in the refrigerator. Do not freeze.
Do not use the medication if it has been frozen.
Store the medication in its original container to protect it from light.
If an unopened container has been stored at room temperature, consult your doctor or pharmacist to determine how long it can be safely stored before disposal.
After opening, store the medication in the refrigerator or at room temperature, protected from heat and light.
Discard any unused medication after 8 weeks.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
Adults: Take a missed dose as soon as you remember. If it is less than 8 hours until your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or extra doses.
* Children: If a dose is missed, consult your child's doctor for guidance on what to do.
To use this medication correctly, follow your doctor's instructions and read all the information provided. For all patients taking this medication:
This medication is administered via injection into the fatty tissue under the skin, typically in the thigh, abdominal area, or upper arm.
If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before use, wash your hands thoroughly.
Rotate the injection site each time to avoid repeated use of the same area.
Avoid injecting into skin that is thickened, has pits or lumps, or is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Do not use the medication if the solution appears cloudy, is leaking, or contains particles, or if the solution has changed color.
Dispose of used needles and syringes in a designated sharps disposal container. Do not reuse needles or other materials. When the container is full, follow local regulations for disposal.
If you have any questions or concerns, consult your doctor or pharmacist.
Important Administration Guidelines
Do not draw the medication into a syringe and store it for future use.
Do not mix this insulin with other types of insulin in the same syringe.
Follow the diet and exercise plan recommended by your doctor.
This medication is not suitable for use in an insulin pump. If you have questions, consult your doctor.
Storage and Disposal
Store unopened pens in the refrigerator. Do not freeze.
Do not use the medication if it has been frozen.
Store the medication in its original container to protect it from light.
If an unopened container has been stored at room temperature, consult your doctor or pharmacist to determine how long it can be safely stored before disposal.
After opening, store the medication in the refrigerator or at room temperature, protected from heat and light.
Discard any unused medication after 8 weeks.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
Adults: Take a missed dose as soon as you remember. If it is less than 8 hours until your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or extra doses.
* Children: If a dose is missed, consult your child's doctor for guidance on what to do.
Lifestyle & Tips
- Administer once daily at any time of day, but preferably at the same time each day. If a dose is missed, take it as soon as you remember, then resume your regular once-daily dosing schedule. Ensure there are at least 8 hours between doses.
- Rotate injection sites within the same region (abdomen, thigh, or upper arm) to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
- Do not mix insulin degludec with other insulins in the same syringe or vial.
- Do not administer intravenously or intramuscularly.
- Always check the insulin label before each injection to avoid medication errors.
- Follow a consistent meal plan and exercise routine as advised by your healthcare provider.
- Carry a source of fast-acting sugar (e.g., glucose tablets, fruit juice) to treat mild to moderate hypoglycemia.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Available Strengths:
- Insulin Aspart 100/ml Inj,10ml
- Insulin Aspa Mix 70/30 Inj Sus 10ml
- Insulin Aspart Penfill Inj, 3ml
- Insulin Aspart Flexpen Inj, 3ml
- Insulin Aspa Mix 70/30 Flexpen, 3ml
- Insulin Lispro Junior Kwikpen 5x3ml
- Insulin Lispro Prt Mix 75/25kwikpen
- Insulin Lispro 100u/ml Vial 10ml
- Insulin Lispro 100u/ml Kwikpen 3ml
- Insulin Glarg-Yfgn 100u/ml Sol 10ml
- Insulin Glarg-Yfgn 100u/ml Pen Inj
- Insulin Glarg Solostar Pen Inj 3ml
- Insulin Glargine 100u/ml, 10ml
- Insulin Degludec U100 Inj Vial 10ml
- Insuln Glargne Solstr U300 PN 1.5ml
- Insulin Glarg U300 Max Solstr Inj
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized, typically 10 units once daily or 1/3 to 1/2 of total daily insulin requirement. Titrate based on fasting plasma glucose.
Condition-Specific Dosing:
Type 1 Diabetes:
Initial total daily dose is approximately 0.2 to 0.4 units/kg. Basal insulin typically comprises 40-50% of the total daily dose.
Type 2 Diabetes:
Initial dose of 10 units once daily. Adjust dose by 2-4 units every 3-4 days based on fasting plasma glucose targets.
Pediatric Dosing
Neonatal:
Not established (approved for age âĨ1 year)
Infant:
Individualized, approved for age âĨ1 year. Initial dose typically 0.2 to 0.4 units/kg/day, with basal insulin comprising 40-50% of total daily dose.
Child:
Individualized, approved for age âĨ1 year. Initial dose typically 0.2 to 0.4 units/kg/day, with basal insulin comprising 40-50% of total daily dose.
Adolescent:
Individualized, approved for age âĨ1 year. Initial dose typically 0.2 to 0.4 units/kg/day, with basal insulin comprising 40-50% of total daily dose.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor glucose closely.
Moderate:
No specific dose adjustment recommended, but monitor glucose closely.
Severe:
No specific dose adjustment recommended, but monitor glucose closely due to increased risk of hypoglycemia.
Dialysis:
No specific dose adjustment recommended, but monitor glucose closely due to increased risk of hypoglycemia.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but monitor glucose closely.
Moderate:
No specific dose adjustment recommended, but monitor glucose closely.
Severe:
No specific dose adjustment recommended, but monitor glucose closely due to increased risk of hypoglycemia.
Pharmacology
Mechanism of Action
Insulin degludec is a long-acting insulin analog that lowers blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly applicable (subcutaneous administration)
Tmax:
9 hours (at steady state)
FoodEffect:
No clinically relevant effect of food on absorption.
Distribution:
Vd:
Approximately 0.1 L/kg
ProteinBinding:
Low (<1%)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 25 hours (effective half-life due to protraction)
Clearance:
Not available (primarily metabolized)
ExcretionRoute:
Primarily renal (after metabolic degradation)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
30-90 minutes
PeakEffect:
Flat and stable profile, no pronounced peak effect
DurationOfAction:
Greater than 42 hours
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 or seek medical attention immediately:
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
Some allergic reactions can be life-threatening.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Thick skin, pits, or lumps at the injection site
Swelling in the arms or legs
Low blood sugar, which may cause:
+ Dizziness or fainting
+ Blurred vision
+ Mood changes
+ Slurred speech
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
+ Seizures
If you experience any of these symptoms, call your doctor right away. If you have low blood sugar, follow the instructions you have been given, which may include taking glucose tablets, liquid glucose, or some fruit juices.
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 notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Nose or throat irritation
Signs of a common cold
Headache
Diarrhea
Weight gain
Irritation at the injection site
This is not a complete list of possible side effects. If you have questions or concerns about side effects, 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, 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 or seek medical attention immediately:
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
Some allergic reactions can be life-threatening.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Thick skin, pits, or lumps at the injection site
Swelling in the arms or legs
Low blood sugar, which may cause:
+ Dizziness or fainting
+ Blurred vision
+ Mood changes
+ Slurred speech
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
+ Seizures
If you experience any of these symptoms, call your doctor right away. If you have low blood sugar, follow the instructions you have been given, which may include taking glucose tablets, liquid glucose, or some fruit juices.
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 notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Nose or throat irritation
Signs of a common cold
Headache
Diarrhea
Weight gain
Irritation at the injection site
This is not a complete list of possible side effects. If you have questions or concerns about side effects, 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: severe confusion, seizures, unconsciousness.
- Symptoms of severe allergic reaction: rash over the whole body, shortness of breath, wheezing, rapid pulse, sweating, swelling of your face or tongue, throat tightness, extreme drowsiness, dizziness.
- Symptoms of heart failure (if taking with TZDs): unusual weight gain, swelling in your feet or ankles, shortness of breath.
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:
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.
Certain health conditions, including:
+ Acidic blood problems
+ Low blood sugar
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
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.
Certain health conditions, including:
+ Acidic blood problems
+ Low blood sugar
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Low Blood Sugar Warning
This medication can cause low blood sugar, which may lead to seizures, loss of consciousness, permanent brain damage, and even death if not treated promptly. Consult your doctor to discuss the risks and prevention strategies.
Low Blood Potassium Warning
This medication can also cause low blood potassium levels, which can lead to abnormal heart rhythms, severe breathing problems, and even death if left untreated. Consult your doctor to discuss the risks and prevention strategies.
Precautions and Interactions
Avoid driving or engaging in activities that require alertness until you understand how this medication affects you. If you are taking diabetes medications like pioglitazone or rosiglitazone, be aware that they may increase the risk of heart failure, especially when used with insulin. Consult your doctor to discuss the potential risks and benefits.
Proper Insulin Use
Ensure you have the correct insulin product and understand how to measure and prepare your dose. Insulin products come in various containers, such as vials, cartridges, and pens. If you have any questions, consult your doctor or pharmacist.
Blood Sugar Control
Be aware that stress, illness, injury, or surgery can affect blood sugar control. Changes in physical activity, exercise, or diet can also impact blood sugar levels.
Safety Precautions
Wear a medical alert identification to ensure prompt treatment in case of an emergency. Do not drive if you have experienced low blood sugar, as it can increase the risk of accidents. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests to ensure safe treatment.
Additional Warnings
Consult your doctor before consuming alcohol or using products containing alcohol. Never share your insulin product, including pens, cartridges, needles, or syringes, with others, as it can transmit infections.
Special Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Low Blood Sugar Warning
This medication can cause low blood sugar, which may lead to seizures, loss of consciousness, permanent brain damage, and even death if not treated promptly. Consult your doctor to discuss the risks and prevention strategies.
Low Blood Potassium Warning
This medication can also cause low blood potassium levels, which can lead to abnormal heart rhythms, severe breathing problems, and even death if left untreated. Consult your doctor to discuss the risks and prevention strategies.
Precautions and Interactions
Avoid driving or engaging in activities that require alertness until you understand how this medication affects you. If you are taking diabetes medications like pioglitazone or rosiglitazone, be aware that they may increase the risk of heart failure, especially when used with insulin. Consult your doctor to discuss the potential risks and benefits.
Proper Insulin Use
Ensure you have the correct insulin product and understand how to measure and prepare your dose. Insulin products come in various containers, such as vials, cartridges, and pens. If you have any questions, consult your doctor or pharmacist.
Blood Sugar Control
Be aware that stress, illness, injury, or surgery can affect blood sugar control. Changes in physical activity, exercise, or diet can also impact blood sugar levels.
Safety Precautions
Wear a medical alert identification to ensure prompt treatment in case of an emergency. Do not drive if you have experienced low blood sugar, as it can increase the risk of accidents. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests to ensure safe treatment.
Additional Warnings
Consult your doctor before consuming alcohol or using products containing alcohol. Never share your insulin product, including pens, cartridges, needles, or syringes, with others, as it can transmit infections.
Special Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Hypoglycemia (low blood sugar)
- Severe hypoglycemia can lead to unconsciousness, seizures, and brain damage.
What to Do:
Mild hypoglycemia can be treated by oral glucose. Severe hypoglycemia requires parenteral glucose (intravenous dextrose) or glucagon. Call 911 or 1-800-222-1222 (Poison Control Center) immediately.
Drug Interactions
Major Interactions
Moderate Interactions
- Oral antidiabetic agents (increased risk of hypoglycemia)
- ACE inhibitors (increased risk of hypoglycemia)
- Angiotensin Receptor Blockers (ARBs) (increased risk of hypoglycemia)
- Disopyramide (increased risk of hypoglycemia)
- Fibrates (increased risk of hypoglycemia)
- Fluoxetine (increased risk of hypoglycemia)
- MAOIs (increased risk of hypoglycemia)
- Pentoxifylline (increased risk of hypoglycemia)
- Pramlintide (increased risk of hypoglycemia)
- Propoxyphene (increased risk of hypoglycemia)
- Salicylates (e.g., aspirin) (increased risk of hypoglycemia)
- Somatostatin analogs (e.g., octreotide) (increased risk of hypoglycemia)
- Sulfonamide antibiotics (increased risk of hypoglycemia)
- Corticosteroids (may decrease hypoglycemic effect)
- Diuretics (may decrease hypoglycemic effect)
- Estrogens (may decrease hypoglycemic effect)
- Progestins (may decrease hypoglycemic effect)
- Atypical antipsychotics (may decrease hypoglycemic effect)
- Danazol (may decrease hypoglycemic effect)
- Diazoxide (may decrease hypoglycemic effect)
- Glucagon (may decrease hypoglycemic effect)
- Isoniazid (may decrease hypoglycemic effect)
- Niacin (may decrease hypoglycemic effect)
- Phenothiazines (may decrease hypoglycemic effect)
- Somatropin (may decrease hypoglycemic effect)
- Sympathomimetics (e.g., epinephrine, albuterol, terbutaline) (may decrease hypoglycemic effect)
- Thyroid hormones (may decrease hypoglycemic effect)
- Clonidine (may mask symptoms of hypoglycemia)
- Guanethidine (may mask symptoms of hypoglycemia)
- Reserpine (may mask symptoms of hypoglycemia)
Monitoring
Baseline Monitoring
HbA1c
Rationale: To establish baseline glycemic control and guide initial dosing.
Timing: Prior to initiation of therapy.
Fasting Plasma Glucose (FPG)
Rationale: To establish baseline glucose levels and guide initial dosing.
Timing: Prior to initiation of therapy.
Renal and Hepatic Function
Rationale: To assess overall health status and potential for altered drug clearance, though no specific dose adjustments are typically needed.
Timing: Prior to initiation of therapy.
Routine Monitoring
Self-Monitoring Blood Glucose (SMBG)
Frequency: Daily, especially fasting glucose, and as needed to assess response to dose adjustments.
Target: Individualized, typically 80-130 mg/dL (fasting)
Action Threshold: Below target: consider dose reduction; Above target: consider dose increase.
HbA1c
Frequency: Every 3-6 months
Target: Individualized, typically <7% for most adults
Action Threshold: Above target: reassess glycemic control and treatment plan.
Signs and Symptoms of Hypoglycemia
Frequency: Ongoing
Target: Not applicable
Action Threshold: Prompt treatment of hypoglycemia; reassess insulin dose if recurrent.
Symptom Monitoring
- Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat)
- Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision, unexplained weight loss)
- Signs of allergic reactions (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of injection site reactions (e.g., redness, swelling, itching, pain, bruising at injection site)
Special Patient Groups
Pregnancy
Insulin degludec is generally considered safe for use during pregnancy. Insulin requirements may change during pregnancy. Close monitoring of blood glucose is essential.
Trimester-Specific Risks:
First Trimester:
Insulin requirements may decrease.
Second Trimester:
Insulin requirements typically increase.
Third Trimester:
Insulin requirements typically increase.
Lactation
Insulin degludec is compatible with breastfeeding. Insulin is a normal component of human milk and is not expected to cause adverse effects in a breastfed infant. No dose adjustment is needed.
Infant Risk:
Low risk (L1 - Safest)
Pediatric Use
Approved for use in pediatric patients aged 1 year and older with type 1 or type 2 diabetes mellitus. Dosing should be individualized based on metabolic needs and glycemic control.
Geriatric Use
No specific dose adjustment is required based on age alone. However, older patients may have increased susceptibility to hypoglycemia due to age-related decline in renal function, polypharmacy, or reduced awareness of hypoglycemic symptoms. Monitor glucose closely.
Clinical Information
Clinical Pearls
- Insulin degludec is an ultra-long-acting basal insulin with a duration of action exceeding 42 hours, allowing for flexible once-daily dosing.
- It has a very flat and stable pharmacokinetic/pharmacodynamic profile with low day-to-day variability, which may reduce the risk of nocturnal hypoglycemia compared to other basal insulins.
- Patients can take their daily dose at any time of day, provided there are at least 8 hours between doses if the dosing time is changed.
- Available in U100 and U200 concentrations (though this specific product is U100 vial). Ensure patients are aware of the concentration they are using.
- Do not use in insulin pumps.
Alternative Therapies
- Other long-acting insulins (e.g., insulin glargine U100/U300, insulin detemir)
- Intermediate-acting insulin (e.g., NPH insulin)
- Oral antidiabetic agents (e.g., metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists - for Type 2 Diabetes)
Cost & Coverage
Average Cost:
Price varies significantly by pharmacy and insurance plan. per 10ml vial
Insurance Coverage:
Tier 2 or 3 (Brand-name 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 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 overdose, including the medication taken, the amount, and the time it occurred.