Tresiba Flextouch Pen (u-100)inj3ml

Manufacturer NOVO NORDISK Active Ingredient Insulin Degludec (U-100) Prefilled Pens(IN su lin de GLOO dek) Pronunciation IN-soo-lin de-GLOO-dek
It is used to lower blood sugar in patients with high blood sugar (diabetes).
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Drug Class
Antidiabetic agent
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Pharmacologic Class
Insulin, long-acting analog
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Pregnancy Category
Not assigned (old system); clinical data suggest no increased risk of congenital malformations with insulin use in pregnancy. Preferred for glycemic control in pregnancy.
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FDA Approved
Sep 2015
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Tresiba is a long-acting insulin that helps control blood sugar levels in people with diabetes. It works by slowly releasing insulin into your body over a long period, helping to keep your blood sugar stable throughout the day and night. It's given as an injection under the skin, usually once a day.
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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, belly area, or upper arm.
If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique.
Before injecting, 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 or has pits or lumps
+ Irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks
Do not use the medication if the solution appears:
+ Cloudy
+ Leaking
+ Contains particles
+ Has changed color
Remove all pen needle covers before injecting a dose (you may have two covers). If you are unsure about the type of pen needle or how to use it, consult your doctor.
Note that the device may produce a clicking sound when preparing the dose. However, do not rely on the clicks to determine the correct dose.
After each injection, remove the needle and do not store the device with the needle attached.
Dispose of used 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.
Consult your doctor or pharmacist if you have any questions or concerns.

Important Administration Guidelines

Do not transfer the medication from the pen to a syringe.
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 containers in the refrigerator. Do not freeze.
If an unopened container has been stored at room temperature, consult your doctor or pharmacist to determine the maximum storage time.
After opening, store the medication in the refrigerator or at room temperature, protecting it from heat and light.
Discard any unused medication after 8 weeks.
Keep all medications in a safe place, out of reach of children and pets.
Dispose of unused or expired medications according to local regulations. Do not flush down the toilet or pour down the drain unless instructed to do so. Consult your pharmacist for guidance on proper disposal.

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 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.
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Lifestyle & Tips

  • Follow your healthcare provider's instructions for diet and exercise.
  • Monitor your blood sugar regularly as instructed.
  • Always have a source of fast-acting sugar (e.g., glucose tablets, juice, candy) readily available to treat low blood sugar.
  • Rotate injection sites within the same region (e.g., abdomen, thigh, upper arm) to prevent skin problems.
  • Never share your insulin pen with others, even if the needle is changed, due to risk of transmitting blood-borne pathogens.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized. Once daily, any time of day, but at the same time each day. For Type 1 Diabetes: Approximately one-third to one-half of the total daily insulin dose as basal insulin. For Type 2 Diabetes: Initial dose 10 units once daily, then titrate.

Condition-Specific Dosing:

Type 1 Diabetes Mellitus: Initial total daily dose is typically 0.2 to 0.4 units/kg/day, with basal insulin (Tresiba) comprising 30-50% of this total. Titrate based on blood glucose levels.
Type 2 Diabetes Mellitus: Initial dose 10 units once daily. Titrate dose by 2 units once or twice weekly based on fasting plasma glucose (FPG) targets. Increase by 2 units if FPG is â‰Ĩ180 mg/dL, by 2 units if FPG is 140-180 mg/dL, by 1 unit if FPG is 110-139 mg/dL. Decrease by 2 units if FPG is <70 mg/dL.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Approved for children 1 year and older with Type 1 or Type 2 Diabetes. Dosing is individualized based on blood glucose levels and metabolic needs. Typically, initial dose for Type 1 is 0.2-0.4 units/kg/day (basal component), and for Type 2, 10 units once daily, similar to adults, then titrated.
Adolescent: Dosing is individualized based on blood glucose levels and metabolic needs, similar to adult recommendations.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but monitor blood glucose closely due to increased risk of hypoglycemia.
Moderate: No specific dose adjustment recommended, but monitor blood glucose closely due to increased risk of hypoglycemia.
Severe: No specific dose adjustment recommended, but monitor blood glucose closely due to increased risk of hypoglycemia.
Dialysis: No specific dose adjustment recommended, but monitor blood glucose closely due to increased risk of hypoglycemia. Insulin requirements may decrease.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, but monitor blood glucose closely due to increased risk of hypoglycemia.
Moderate: No specific dose adjustment recommended, but monitor blood glucose closely due to increased risk of hypoglycemia.
Severe: No specific dose adjustment recommended, but monitor blood glucose closely due to increased risk of hypoglycemia.

Pharmacology

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Mechanism of Action

Insulin degludec is a long-acting basal insulin analog. After subcutaneous injection, it forms soluble multi-hexamers, which leads to a continuous and slow release of insulin degludec monomers into the circulation. These monomers bind to insulin receptors, facilitating glucose uptake by peripheral tissues (especially skeletal muscle and adipose tissue) and inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: High (subcutaneous)
Tmax: 9 hours (range 2-12 hours) due to multi-hexamer formation and slow absorption.
FoodEffect: Not applicable (subcutaneous injection, not affected by food intake).

Distribution:

Vd: Approximately 0.1 L/kg
ProteinBinding: >99% (due to fatty acid side chain binding to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 25 hours (effective half-life, allowing for once-daily dosing)
Clearance: Approximately 0.02 L/kg/hr
ExcretionRoute: Primarily renal, after metabolic degradation.
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 30-90 minutes
PeakEffect: Relatively flat profile, no pronounced peak effect, reaching steady state after 2-3 days of once-daily dosing.
DurationOfAction: Greater than 42 hours
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 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 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 contact your doctor or seek medical help if you're bothered by any of the following:

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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of severe hypoglycemia (seizures, unconsciousness, severe confusion)
  • Symptoms of severe allergic reaction (rash over whole body, shortness of breath, wheezing, fast heartbeat, sweating, swelling of face/tongue/throat)
  • Symptoms of heart failure (unusual weight gain, swelling in hands/feet, shortness of breath) if taking certain other diabetes medications (TZDs).
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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. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

This drug can cause low blood sugar, which may lead to seizures, loss of consciousness, permanent brain damage, and even death if not properly managed. It is crucial to discuss this risk with your doctor. Additionally, this medication can cause low blood potassium levels, which, if left untreated, can result in abnormal heart rhythms, severe breathing difficulties, and potentially death. If you experience any symptoms, consult your doctor promptly.

Until you understand how this medication affects you, avoid driving and other activities that require your full attention. Certain diabetes medications, such as pioglitazone or rosiglitazone, may increase the risk of heart failure or worsen existing heart failure, especially when combined with insulin. If you are taking one of these medications, consult your doctor to discuss the potential risks.

Ensure you are using the correct insulin product, as they come in various containers, including vials, cartridges, and pens. If you are unsure about measuring or preparing your dose, consult your doctor or pharmacist for guidance.

During periods of stress, such as illness, infection, injury, or surgery, it may be more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar levels.

Wear a medical alert identification to inform others of your condition in case of an emergency. Avoid driving if you have experienced low blood sugar, as it increases the risk of accidents. Monitor your blood sugar levels as instructed by your doctor and undergo regular blood tests as recommended.

Before consuming alcohol or using products containing alcohol, consult your doctor to discuss potential risks. Never share your insulin product, including pens, cartridge devices, needles, or syringes, with others, even if the needle has been changed, as this can transmit infections.

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 of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (low blood sugar)
  • Confusion
  • Drowsiness
  • Blurred vision
  • Slurred speech
  • Muscle weakness
  • Seizures
  • Loss of consciousness
  • Hypokalemia (low potassium, though less common with insulin overdose than with other conditions)

What to Do:

Immediately consume fast-acting carbohydrates (e.g., glucose tablets, juice, regular soda, honey). For severe hypoglycemia, administer glucagon if available and call emergency medical services. Call 911 or 1-800-222-1222 (Poison Control Center).

Drug Interactions

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Major Interactions

  • Beta-blockers (may mask symptoms of hypoglycemia, prolong recovery from hypoglycemia)
  • Thiazolidinediones (TZDs) - e.g., pioglitazone, rosiglitazone (increased risk of fluid retention and heart failure when used with insulin)
  • Alcohol (may potentiate or reduce the hypoglycemic effect of insulin)
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Moderate Interactions

  • Oral antidiabetic agents (additive glucose-lowering effect, increased risk of hypoglycemia)
  • Corticosteroids (may increase blood glucose, requiring higher insulin doses)
  • Diuretics (thiazide and loop diuretics may cause hyperglycemia, requiring higher insulin doses)
  • Sympathomimetics (e.g., epinephrine, albuterol, terbutaline - may increase blood glucose)
  • Growth hormone (may increase blood glucose)
  • Danazol (may increase blood glucose)
  • Somatostatin analogs (e.g., octreotide, lanreotide - may decrease insulin requirements)
  • Salicylates (e.g., aspirin, especially high doses - may enhance insulin's glucose-lowering effect)
  • Sulfonamide antibiotics (may enhance insulin's glucose-lowering effect)
  • MAO inhibitors (may enhance insulin's glucose-lowering effect)
  • ACE inhibitors (may enhance insulin's glucose-lowering effect)
  • Angiotensin Receptor Blockers (ARBs) (may enhance insulin's glucose-lowering effect)

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control and guide initial therapy.

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 function (eGFR, BUN, Creatinine)

Rationale: To assess kidney function, as renal impairment can increase risk of hypoglycemia.

Timing: Prior to initiation, especially in elderly or those with risk factors.

Hepatic function (ALT, AST, Bilirubin)

Rationale: To assess liver function, as hepatic impairment can increase risk of hypoglycemia.

Timing: Prior to initiation, especially in those with risk factors.

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Routine Monitoring

Self-monitoring of Blood Glucose (SMBG)

Frequency: Multiple times daily (e.g., fasting, pre-meal, post-meal, bedtime) for Type 1 DM; at least fasting for Type 2 DM, or as directed by healthcare provider.

Target: Individualized, typically 80-130 mg/dL pre-meal, <180 mg/dL 1-2 hours post-meal.

Action Threshold: Adjust insulin dose based on trends and specific targets. Hypoglycemia (<70 mg/dL) requires immediate action and dose adjustment.

HbA1c

Frequency: Every 3-6 months (or more frequently if glycemic control is suboptimal).

Target: <7% for most adults (individualized).

Action Threshold: If above target, consider dose adjustment or addition of other agents.

Signs and symptoms of hypoglycemia

Frequency: Daily, ongoing.

Target: N/A

Action Threshold: If symptoms occur, check blood glucose and treat immediately. Review insulin regimen.

Injection site inspection

Frequency: Regularly (e.g., daily or weekly).

Target: N/A

Action Threshold: Rotate injection sites to prevent lipodystrophy. Report any skin changes.

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Symptom Monitoring

  • Hypoglycemia (sweating, shakiness, dizziness, confusion, hunger, irritability, rapid heartbeat, blurred vision, headache, slurred speech, anxiety, weakness)
  • Hyperglycemia (increased thirst, increased urination, fatigue, blurred vision, headache)
  • Injection site reactions (redness, swelling, itching, pain, bruising)
  • Signs of fluid retention/heart failure (unexplained weight gain, swelling in ankles/feet, shortness of breath) if used with TZDs
  • Allergic reactions (rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing)

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for glycemic control in pregnant women with diabetes. Insulin degludec has been studied in pregnancy, and clinical data do not suggest an increased risk of congenital malformations or adverse maternal/fetal outcomes compared to other insulins. Close monitoring of blood glucose is essential, and insulin requirements may change throughout pregnancy.

Trimester-Specific Risks:

First Trimester: Insulin requirements may decrease due to nausea/vomiting. Close monitoring needed to prevent hypoglycemia.
Second Trimester: Insulin requirements typically increase due to increasing insulin resistance.
Third Trimester: Insulin requirements continue to increase, often peaking in the late third trimester. Close monitoring and dose adjustments are crucial.
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Lactation

Insulin is considered compatible with breastfeeding. Insulin degludec is a large protein molecule and is unlikely to pass into breast milk in clinically significant amounts. It is not expected to cause adverse effects in breastfed infants. Maternal insulin requirements may change during lactation.

Infant Risk: Low risk to infant.
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Pediatric Use

Approved for children 1 year and older with Type 1 or Type 2 Diabetes. Dosing is individualized based on blood glucose levels and metabolic needs. Close monitoring for hypoglycemia is crucial, especially in younger children who may not recognize symptoms.

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Geriatric Use

No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to the hypoglycemic effects of insulin and may have impaired renal or hepatic function, which can increase the risk of hypoglycemia. Start with lower doses and titrate cautiously, with close monitoring of blood glucose.

Clinical Information

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Clinical Pearls

  • Tresiba has a very long duration of action (>42 hours), allowing for flexibility in dosing time (can be given at any time of day, but should be given at the same time each day). If a dose is missed, it can be taken as soon as the patient remembers, then resume the regular once-daily dosing schedule. Ensure at least 8 hours between doses.
  • Due to its ultra-long action, Tresiba provides a very stable basal insulin profile with less day-to-day variability compared to other basal insulins, potentially reducing nocturnal hypoglycemia.
  • Patients should be educated on proper injection technique, site rotation, and storage (refrigerated until first use, then room temperature for up to 56 days after first use).
  • Always verify the insulin type (U-100) and concentration to avoid dosing errors.
  • Patients transitioning from other basal insulins may require dose adjustments and close monitoring, especially when switching from twice-daily basal insulin to once-daily Tresiba.
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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): Metformin, Sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, etc.
  • Other injectable non-insulin agents (for Type 2 Diabetes): GLP-1 receptor agonists, Amylin analogs (pramlintide)
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Cost & Coverage

Average Cost: Varies widely, typically several hundred dollars per 3ml pen (U-100)
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand), may require prior authorization.
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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, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.