Tresiba 100unit Inj, 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?
Tresiba 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, helping to keep your blood sugar levels stable throughout the day and night. It is used to treat diabetes in adults and children 1 year and older.
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 in a designated sharps 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.
Administration in Children
Administer the medication at the same time every day.
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 the maximum storage time 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 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 in a designated sharps 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.
Administration in Children
Administer the medication at the same time every day.
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 the maximum storage time 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 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
- Follow your prescribed diet plan and exercise regimen.
- Monitor your blood sugar levels regularly as instructed by your doctor.
- Always carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat low blood sugar.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products.
- Do not share your insulin pen or vial with others, even if the needle is changed, as this carries a risk of blood-borne pathogen transmission.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on metabolic needs, blood glucose monitoring, and glycemic control goal. Administer subcutaneously once daily at any time of day, but at the same time each day. For insulin-naïve patients, initial dose is typically 10 units once daily. For patients switching from other basal insulins, initial dose is unit-for-unit.
Condition-Specific Dosing:
Type 1 Diabetes:
Initial dose approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be administered as a short-acting insulin.
Type 2 Diabetes:
Initial dose 10 units once daily, then adjust based on glycemic response.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (approved for 1 year and older)
Child:
Approved for children 1 year and older. Dosing individualized, similar to adults, based on metabolic needs and glycemic control.
Adolescent:
Dosing individualized, similar to adults, based on metabolic needs and glycemic control.
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.
Dialysis:
No specific dose adjustment recommended, but monitor glucose closely. Insulin requirements may be reduced.
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.
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:
High (subcutaneous)
Tmax:
Not well-defined due to flat profile; steady state reached in 2-3 days.
FoodEffect:
No clinically relevant effect of food on absorption.
Distribution:
Vd:
Approximately 0.1 L/kg
ProteinBinding:
<1%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 25 hours
Clearance:
Not available (primarily degraded)
ExcretionRoute:
Primarily renal after degradation
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Approximately 30-90 minutes
PeakEffect:
No pronounced peak (flat profile)
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 immediate 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
Some allergic reactions can be life-threatening, so prompt medical attention is crucial.
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 your doctor's instructions, 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or persist:
Nose or throat irritation
Signs of a common cold
Headache
Diarrhea
Weight gain
Irritation at the injection site
This is not an exhaustive list of 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 or seek immediate 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
Some allergic reactions can be life-threatening, so prompt medical attention is crucial.
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 your doctor's instructions, 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or persist:
Nose or throat irritation
Signs of a common cold
Headache
Diarrhea
Weight gain
Irritation at the injection site
This is not an exhaustive list of 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:
- Symptoms of severe low blood sugar (hypoglycemia): Seizures, unconsciousness, severe confusion. Seek immediate medical help.
- Symptoms of high blood sugar (hyperglycemia) or diabetic ketoacidosis (DKA): Extreme thirst, frequent urination, nausea, vomiting, abdominal pain, fruity breath odor, rapid breathing. Seek immediate medical help.
- Signs of allergic reaction: Rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing. Seek immediate medical help.
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 the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all 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 the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all 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 Risk
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. Discuss this risk with your doctor.
Low Blood Potassium Risk
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. Talk to your doctor if you have concerns.
Precautions and Interactions
Avoid driving and other 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. Discuss this risk with your doctor.
Proper Insulin Product 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 questions, consult your doctor or pharmacist.
Blood Sugar Control During Stressful Situations
Stressful events like fever, infection, injury, or surgery can make it more challenging to control blood sugar levels. Changes in physical activity, exercise, or diet can also impact blood sugar control.
Safety Precautions
Wear a medical alert identification (ID) to indicate your condition. Do not drive if you have experienced low blood sugar, as it increases the risk of accidents. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as recommended.
Additional Safety Information
Before consuming alcohol or using products containing alcohol, consult your doctor. Never share your insulin product, including pens, cartridge devices, needles, or syringes, with others, as this can transmit infections.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the 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 Risk
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. Discuss this risk with your doctor.
Low Blood Potassium Risk
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. Talk to your doctor if you have concerns.
Precautions and Interactions
Avoid driving and other 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. Discuss this risk with your doctor.
Proper Insulin Product 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 questions, consult your doctor or pharmacist.
Blood Sugar Control During Stressful Situations
Stressful events like fever, infection, injury, or surgery can make it more challenging to control blood sugar levels. Changes in physical activity, exercise, or diet can also impact blood sugar control.
Safety Precautions
Wear a medical alert identification (ID) to indicate your condition. Do not drive if you have experienced low blood sugar, as it increases the risk of accidents. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as recommended.
Additional Safety Information
Before consuming alcohol or using products containing alcohol, consult your doctor. Never share your insulin product, including pens, cartridge devices, needles, or syringes, with others, as this can transmit infections.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (low blood sugar)
- Hypokalemia (low potassium levels)
What to Do:
Severe hypoglycemic episodes may require parenteral glucose or glucagon administration. Hypokalemia should be corrected. Call 911 or your local emergency number. For less severe cases, consume fast-acting carbohydrates. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Moderate Interactions
- Beta-blockers (may mask symptoms of hypoglycemia)
- Clonidine (may mask symptoms of hypoglycemia)
- Guanethidine (may mask symptoms of hypoglycemia)
- Reserpine (may mask symptoms of hypoglycemia)
- Alcohol (may potentiate or reduce hypoglycemic effect)
- Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure when used with insulin)
Monitoring
Baseline Monitoring
Glycated Hemoglobin (HbA1c)
Rationale: To establish baseline glycemic control and guide initial dosing.
Timing: Prior to initiation
Fasting Plasma Glucose (FPG)
Rationale: To establish baseline glucose levels and guide initial dosing.
Timing: Prior to initiation
Renal function (e.g., eGFR, creatinine)
Rationale: To assess kidney function, as insulin requirements may change in renal impairment.
Timing: Prior to initiation
Hepatic function (e.g., LFTs)
Rationale: To assess liver function, as insulin requirements may change in hepatic impairment.
Timing: Prior to initiation
Routine Monitoring
Self-monitoring Blood Glucose (SMBG)
Frequency: Multiple times daily (e.g., fasting, pre-meal, post-meal, bedtime) as directed by healthcare provider.
Target: Individualized, typically 80-130 mg/dL fasting/pre-meal, <180 mg/dL 2 hours post-meal.
Action Threshold: Adjust insulin dose based on trends and individual glycemic targets. Seek medical attention for persistent hypo- or hyperglycemia.
Glycated Hemoglobin (HbA1c)
Frequency: Every 3-6 months
Target: Individualized, typically <7% for most adults.
Action Threshold: Adjust insulin regimen if target not met.
Signs and symptoms of hypoglycemia
Frequency: Daily, ongoing
Target: N/A
Action Threshold: Treat immediately with fast-acting carbohydrates if blood glucose <70 mg/dL or symptoms present. Seek medical attention for severe or recurrent episodes.
Signs and symptoms of hyperglycemia/DKA
Frequency: Daily, ongoing
Target: N/A
Action Threshold: Seek medical attention for persistent high blood glucose, polyuria, polydipsia, fatigue, nausea, vomiting, or fruity breath.
Symptom Monitoring
- Hypoglycemia: Sweating, dizziness, confusion, irritability, hunger, headache, blurred vision, slurred speech, tremor, anxiety, rapid heartbeat.
- Hyperglycemia: Increased thirst, increased urination, fatigue, blurred vision, headache, nausea, vomiting, abdominal pain (especially in DKA).
Special Patient Groups
Pregnancy
Insulin degludec is generally considered safe for use during pregnancy when clinically indicated. Available data from published observational studies and postmarketing reports have not reported a clear association with adverse developmental outcomes. Careful monitoring of blood glucose is essential to minimize risks to both mother and fetus.
Trimester-Specific Risks:
First Trimester:
Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis and preeclampsia and the fetal risk for major birth defects, stillbirth, and macrosomia.
Second Trimester:
Insulin requirements typically increase during the second and third trimesters.
Third Trimester:
Insulin requirements typically increase during the second and third trimesters.
Lactation
Insulin degludec is considered safe for use during lactation. Insulin is a large protein and is not excreted into breast milk in clinically significant amounts. It is not expected to cause adverse effects in a breastfed infant.
Infant Risk:
Low risk
Pediatric Use
Approved for children 1 year and older. Dosing must be individualized and carefully monitored to avoid hypoglycemia. Risk of hypoglycemia may be higher in younger children.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity to insulin and increased risk of hypoglycemia may occur. Careful glucose monitoring and dose titration are recommended.
Clinical Information
Clinical Pearls
- Insulin degludec is an ultra-long-acting basal insulin with a duration of action exceeding 42 hours, allowing for flexible dosing times (e.g., if a dose is missed, it can be taken when remembered, provided at least 8 hours have passed since the last dose).
- It has a very flat and stable glucose-lowering profile, which may lead to a lower risk of nocturnal hypoglycemia compared to other basal insulins.
- Tresiba U-100 is available in vials and FlexTouch pens. Tresiba U-200 is only available in FlexTouch pens.
- Patients should be educated on proper injection technique, site rotation, and storage.
- Always verify the insulin type and concentration before administration to prevent dosing errors.
Alternative Therapies
- Other long-acting insulins: Insulin glargine (Lantus, Toujeo, Basaglar), Insulin detemir (Levemir)
- Intermediate-acting insulins: NPH insulin
- Oral antidiabetic agents (for Type 2 Diabetes)
- GLP-1 receptor agonists (for Type 2 Diabetes)
Cost & Coverage
Average Cost:
Varies widely, typically several hundred dollars 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'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 occurred.