Tresiba Flextouch Pen(u-200)inj 3ml

Manufacturer NOVO NORDISK Active Ingredient Insulin Degludec (U-200) 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, Insulin
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Pharmacologic Class
Insulin analog, ultra-long-acting
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Pregnancy Category
Not available
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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 Flextouch Pen (U-200) contains a type of insulin called insulin degludec. It is a very long-acting insulin that helps your body use sugar for energy and lowers your blood sugar levels. It is given once a day by injection under the skin. The U-200 means it is twice as concentrated as standard insulin, so you will inject half the volume for the same number of units.
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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, abdominal 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, 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.

Preparing and Administering the Dose

Remove all pen needle covers before injecting a dose (you may have two covers).
If you are unsure about the type of pen needle you have or how to use it, consult your doctor.
You may hear a clicking sound when preparing the dose; however, do not rely on the clicks to determine the correct dose.
After injecting, remove the needle and do not store the device with the needle attached.
Dispose of used needles in a designated sharps disposal container. Do not reuse needles or other materials.
When the disposal container is full, follow local regulations for proper disposal. If you have questions, consult your doctor or pharmacist.

Important Administration Instructions

Do not transfer this 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.

Administration in Children

Administer this medication at the same time every day.

Storage and Disposal

Store unopened containers in the refrigerator. Do not freeze.
Do not use the medication if it has been frozen.
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, protected from heat and light.
Discard any unused medication after 8 weeks.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on proper disposal methods, including potential drug take-back programs in your area.

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.
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Lifestyle & Tips

  • Follow your healthcare provider's instructions for diet and exercise.
  • Monitor your blood sugar levels regularly as instructed.
  • Do not share your Tresiba Flextouch Pen with anyone else, even if the needle is changed, as this carries a risk of infection.
  • Always use a new needle for each injection.
  • Rotate injection sites within the same region (e.g., abdomen, thigh, upper arm) to prevent lipodystrophy (skin changes).
  • Do not mix Tresiba with other insulins or solutions.
  • Do not use if the solution is cloudy, colored, or contains particles.
  • Carry a source of fast-acting sugar (e.g., glucose tablets, fruit juice) to treat mild to moderate hypoglycemia.

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized, typically 10 units once daily for insulin-naive patients, adjusted based on blood glucose levels. Administered subcutaneously.

Condition-Specific Dosing:

Type 1 Diabetes Mellitus: Approximately one-third to one-half of the total daily insulin dose, with the remainder as short-acting insulin. Initial dose 10 units once daily or 0.2-0.4 units/kg/day.
Type 2 Diabetes Mellitus: Initial dose 10 units once daily, or 0.1-0.2 units/kg once daily. Titrate based on fasting plasma glucose (FPG) targets.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Approved for children â‰Ĩ1 year of age with Type 1 or Type 2 diabetes. Initial dose for Type 1: Approximately one-third to one-half of the total daily insulin dose. Initial dose for Type 2: 10 units once daily. Dosing must be individualized.
Adolescent: Approved for adolescents â‰Ĩ1 year of age with Type 1 or Type 2 diabetes. Initial dose for Type 1: Approximately one-third to one-half of the total daily insulin dose. Initial dose for Type 2: 10 units once daily. Dosing must be individualized.
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment generally required, but monitor glucose closely.
Moderate: No specific dose adjustment recommended, but monitor glucose closely and adjust dose as needed.
Severe: No specific dose adjustment recommended, but monitor glucose closely and adjust dose as needed. Increased risk of hypoglycemia.
Dialysis: No specific dose adjustment recommended, but monitor glucose closely and adjust dose as needed. Increased risk of hypoglycemia.

Hepatic Impairment:

Mild: No dose adjustment generally required, but monitor glucose closely.
Moderate: No specific dose adjustment recommended, but monitor glucose closely and adjust dose as needed. Increased risk of hypoglycemia.
Severe: No specific dose adjustment recommended, but monitor glucose closely and adjust dose as needed. Increased risk of hypoglycemia.

Pharmacology

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Mechanism of Action

Insulin degludec is a long-acting insulin analog that forms soluble multi-hexamers upon subcutaneous injection, resulting in a continuous, slow release of insulin degludec monomers. 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: Not available (subcutaneous administration)
Tmax: 9 hours (range 2-12 hours)
FoodEffect: No clinically relevant effect of food on absorption.

Distribution:

Vd: Approximately 10.5 L
ProteinBinding: >99% (to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 25 hours
Clearance: Not available (primarily renal and hepatic degradation)
ExcretionRoute: Primarily metabolic degradation, followed by renal excretion of metabolites.
Unchanged: Negligible
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Pharmacodynamics

OnsetOfAction: 30-90 minutes
PeakEffect: No pronounced peak (flat and stable glucose-lowering effect)
DurationOfAction: Greater than 42 hours
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor 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, 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 for treatment, 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 have mild ones, it's essential to report any concerns to your doctor. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Nose or throat irritation
Signs of a common cold
Headache
Diarrhea
Weight gain
Irritation at the injection site

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to 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 low blood sugar (hypoglycemia): sweating, dizziness, confusion, hunger, irritability, headache, blurred vision, slurred speech, tremor, anxiety, fast heartbeat. Treat immediately.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, increased urination, fatigue, blurred vision, weight loss. Contact your doctor if persistent.
  • Symptoms of serious allergic reaction: rash over your whole body, shortness of breath, wheezing, fast heartbeat, sweating, feeling faint. Seek immediate medical attention.
  • Symptoms of heart failure (if taking with certain other diabetes medicines called TZDs): unusual weight gain, swelling in your hands or feet, shortness of breath.
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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. Never start, stop, or change the dose 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.

Low blood sugar (hypoglycemia) is a potential side effect of this drug, and severe cases can lead to seizures, loss of consciousness, permanent brain damage, and even death. It is crucial to discuss this risk with your doctor. Additionally, this medication may cause low blood potassium (hypokalemia), 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, especially when used in conjunction with insulin. If you are taking one of these medications, consult your doctor to discuss the potential risks.

To ensure safe use, verify that you have the correct insulin product and are familiar with its administration. Insulin products are available in various containers, including vials, cartridges, and pens. If you have any questions or concerns about measuring or preparing your dose, contact your doctor or pharmacist.

Stressful situations, such as fever, infection, injury, or surgery, can make it more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar control. Wear a medical alert identification to ensure prompt treatment in case of an emergency.

Avoid driving if you have experienced low blood sugar, as it can increase your risk of being involved in an accident. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests to assess your condition. Consult your doctor before consuming alcohol or using products containing alcohol.

Do not share your insulin product, including pens, cartridge devices, needles, or syringes, with others, even if the needle has been changed. Sharing can transmit infections, including those you may not be aware of having.

This particular brand of insulin is twice as concentrated as other brands, so exercise caution when measuring your dose to avoid accidental overdose, which can lead to severe side effects or life-threatening low blood sugar. Consult your doctor if you have any concerns.

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 potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (low blood sugar)
  • Hypokalemia (low potassium levels)

What to Do:

Severe hypoglycemia may require parenteral glucose (intravenous dextrose) or glucagon. Mild to moderate hypoglycemia can be treated with oral glucose. Monitor potassium levels and correct if necessary. Call 1-800-222-1222 (Poison Control) or seek emergency medical attention.

Drug Interactions

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Moderate Interactions

  • Beta-blockers (may mask hypoglycemia symptoms)
  • Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure)
  • Corticosteroids (may increase insulin requirements)
  • Diuretics (may increase insulin requirements)
  • Sympathomimetics (may increase insulin requirements)
  • Growth hormone (may increase insulin requirements)
  • Danazol (may increase insulin requirements)
  • Thyroid hormones (may increase insulin requirements)
  • Oral contraceptives (may increase insulin requirements)
  • Salicylates (e.g., aspirin) (may decrease insulin requirements)
  • Sulfonamide antibiotics (may decrease insulin requirements)
  • Monoamine oxidase inhibitors (MAOIs) (may decrease insulin requirements)
  • Angiotensin-converting enzyme (ACE) inhibitors (may decrease insulin requirements)
  • Angiotensin receptor blockers (ARBs) (may decrease insulin requirements)
  • Alcohol (may potentiate or reduce hypoglycemic effect)

Monitoring

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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 glycemic control and guide initial dosing.

Timing: Prior to initiation of therapy.

Renal function (eGFR, creatinine)

Rationale: To assess kidney function, as insulin requirements may change with renal impairment.

Timing: Prior to initiation, especially in patients with known or suspected renal impairment.

Hepatic function (ALT, AST)

Rationale: To assess liver function, as insulin requirements may change with hepatic impairment.

Timing: Prior to initiation, especially in patients with known or suspected hepatic impairment.

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Routine Monitoring

Self-monitoring of Blood Glucose (SMBG)

Frequency: Multiple times daily (Type 1 DM), or as directed by healthcare provider (Type 2 DM).

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

Action Threshold: Hypoglycemia (<70 mg/dL) or persistent hyperglycemia (>180-250 mg/dL).

HbA1c

Frequency: Every 3-6 months.

Target: Individualized, typically <7% for most adults.

Action Threshold: Above target range indicates need for dose adjustment or therapy modification.

Signs/symptoms of hypoglycemia

Frequency: Daily, patient education on recognition.

Target: N/A

Action Threshold: Immediate treatment of hypoglycemia.

Injection site inspection

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

Target: N/A

Action Threshold: Presence of lipodystrophy, redness, swelling, or pain.

Potassium levels

Frequency: Periodically, especially in patients at risk for hypokalemia (e.g., on diuretics).

Target: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia (<3.5 mEq/L) requires intervention.

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, dizziness, confusion, hunger, irritability, headache, blurred vision, slurred speech, tremor, anxiety, fast heartbeat)
  • Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision, weight loss)
  • Signs of allergic reactions (e.g., rash, itching, swelling, difficulty breathing)
  • Signs of fluid retention/heart failure (e.g., unusual weight gain, swelling in ankles/feet, shortness of breath) if used with TZDs

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for diabetes in pregnancy. While animal studies have not shown direct harm, human data are limited. Careful monitoring of blood glucose is essential. The U-200 concentration should be used with caution to avoid dosing errors.

Trimester-Specific Risks:

First Trimester: No specific risks identified beyond general diabetes management.
Second Trimester: No specific risks identified beyond general diabetes management.
Third Trimester: No specific risks identified beyond general diabetes management.
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Lactation

Insulin degludec is considered compatible with breastfeeding (L3). Insulin is a normal component of breast milk and is not orally absorbed by the infant. Maternal insulin requirements may change during lactation.

Infant Risk: Low risk to infant. Monitor infant for signs of hypoglycemia (e.g., lethargy, poor feeding) if maternal doses are very high, though unlikely.
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Pediatric Use

Approved for children â‰Ĩ1 year of age with Type 1 or Type 2 diabetes. Dosing must be individualized and carefully monitored. The U-200 concentration requires careful attention to dose dialing to avoid errors, especially in younger children.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more susceptible to the hypoglycemic effects of insulin and may have age-related renal or hepatic impairment, requiring closer glucose monitoring and dose adjustment. Start low and titrate slowly.

Clinical Information

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Clinical Pearls

  • Tresiba U-200 is twice as concentrated as U-100. The dose window on the Flextouch pen shows the number of units, not the volume, simplifying dosing for patients accustomed to U-100.
  • Due to its ultra-long duration of action (>42 hours), Tresiba can be administered at any time of day, as long as it's at the same time each day, or with at least 8 hours between doses if flexibility is needed.
  • Patients transitioning from other basal insulins may require dose adjustments and close monitoring to avoid hypoglycemia.
  • Emphasize proper injection technique and site rotation to prevent lipodystrophy.
  • Educate patients on the symptoms and management of hypoglycemia, as the prolonged action means hypoglycemia can be sustained.
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Alternative Therapies

  • Other long-acting insulins (e.g., insulin glargine U-100/U-300, insulin detemir)
  • Intermediate-acting insulins (e.g., NPH insulin)
  • Oral antidiabetic agents (e.g., metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists) for Type 2 Diabetes.
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Cost & Coverage

Average Cost: Not available per 3ml pen
Insurance Coverage: Tier 3 or 4 (Non-preferred brand)
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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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.