Tresiba Flextouch Pen(u-200)inj 3ml
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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.
Before Using This Medicine
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
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.
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
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
Baseline Monitoring
Rationale: To establish baseline glycemic control and guide initial dosing.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline glycemic control and guide initial dosing.
Timing: Prior to initiation of therapy.
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.
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.
Routine Monitoring
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).
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.
Frequency: Daily, patient education on recognition.
Target: N/A
Action Threshold: Immediate treatment of hypoglycemia.
Frequency: Regularly (e.g., daily or weekly).
Target: N/A
Action Threshold: Presence of lipodystrophy, redness, swelling, or pain.
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.
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
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:
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.
Pediatric Use
Approved for children âĨ1 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.
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
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.
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.