Tresiba FlexTouch 100 Units / mL - 5x3ml
Tresiba FlexTouch 100
Insulin degludec
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Insulin degludec is an long-acting insulin, similar to the insulin produced by the pancreas in our body to lower glucose levels. It replaces the insulin normally produced in our body and acts longer than regular insulin.

By controlling glycemia control, diabetics can avoid serious complications such as nerve problems, kidney damage, blindness, loss of limbs, stroke or heart attack.

Insulin degludec is often prescribed in combination with a short-acting insulin. Your doctor may also recommend making dietary and exercise as part of your treatment.

What is Tresiba?

Tresiba (insulin degludec) is a long-acting insulin taken once daily to help improve glycemic control in patients with type 1 and type 2 diabetes over the age of 1.

Insulin degludec replaces the insulin the body normally produces. It acts longer than regular insulin and provides a low steady release throughout the day. It helps blood glucose get into the body’s cells to be used as energy.

Insulin degludec can be used along with other diabetes drugs including a shorter-acting insulin product.

What is Tresiba FlexTouch U-100?

Tresiba FlexTouch U-100 (100 units/mL) Pen is as a pre-filled disposable pen that contains 300 units of insulin.

USAGE

Insulin degludec should be used in combination with a healthy diet and regular exercise to control glycemic levels. Through proper blood sugar control, patients can avoid adverse side effects such as kidney damage, nerve problems, loss of sexual function or loss of limbs. Proper management of diabetes can help avoid heart attack or stroke.

How does the Tresiba FlexTouch U-100 work?

This medication is to be injected under the skin (subcutaneously).

Tresiba begins working several hours after injection and works continuously up to 24 hours.

At least 8 hours should elapse before patients consider 2 consecutive doses. Patients should separate doses by 3-4 days if they plan on increasing dosage.

How to use the Tresiba Flexpen?

Before injecting insulin, make sure you are using the correct medication.

Review all patients information and guides available that are provided by your pharmacist to familiarize yourself your prescription.

Inspect your insulin does not have particles or discoloration before use. If either is present do not use. Insulin should appear clear and colorless.

Before administering Tresiba, clean the area for injection with a cotton swab and alcohol.

Rotate injection sites to avoid developing problems such as lipodystrophy.

Tresiba can be injected in the upper thigh, upper arm or stomach area. Do not inject into a muscle or vein as this may cause hypoglycemia.

Do not inject into skin that is swollen, red or itchy.

Do not mix with other insulin or use with an infusion pump.

Storage

It is recommended to refrigerate all unopened insulin medication. Unopened Tresiba can also be stored at room temperature however should be thrown away after 56 days.

Storing Tresiba (in-use):

Can be kept at room temperature (below 86°F) or refrigerated (36°F to 46°F) for 8 weeks (56 days).

Should be stored away from direct sunlight and heat.

Do not freeze or use insulin that has been frozen.

Keep medication away from children and pets.

Do not dispose of medication in household trash or waste water (down sink or toilet).

Speak to your pharmacist about how to properly dispose of medication.

SIDE EFFECTS

If you experience signs of severe allergic reactions to Tresiba, seek medical attention. Symptoms of allergic reactions may include:

  • skin rash
  • itching
  • hives
  • nausea
  • wheezing
  • difficulty breathing
  • feeling you may pass out
  • tiredness
  • diarrhea
  • swelling of lips, throat, face or tongue

Contact your doctor immediately if you have:

Fluid retention:

  • swelling of hands or feet
  • difficulty breathing
  • weight gain

Low potassium:

  • irregular heartbeat
  • constipation
  • increased thirst
  • fluttering in your chest
  • leg cramps
  • numbness or tingling
  • muscle weakness
  • limp feeling

Common Tresiba side effects may include:

  • hypoglycemia (low blood sugar)
  • weight gain or swelling
  • itching, redness, thickening or hollowing at site of injection

Side Effects in Detail

Hypoglycemia (low blood sugar)

Hypoglycemia is the most common side effect with using insulin, including Tresiba.

Symptoms of hypoglycemia may include:

  • increased thirst
  • increased urination
  • drowsiness
  • flushing
  • difficulty breathing
  • fruity breath
  • confusion
  • hunger
  • blurred vision
  • tingling hands/feet
  • shaking
  • sudden sweating

To avoid severe episodes of hypoglycemia, patients should carry a glucose tablet, sugary snack (such as hard candy, raisins, table, sugar, jelly beans) or sugary drink (fruit juice, non-diet soda).

Patients who experience severe hypoglycemia may require getting an emergency glucagon kit. Family and friends should be instructed on what to do in the event a diabetic has loss consciousness and they need to administer glucagon.

To prevent hypoglycemia, eat meals on a regular schedule and do not skip meals. Inform your doctor if you experience hypoglycemia so they can tell you what to do if you miss a dose or how to manage episodes of hypoglycemia.

Hypokalemia (low potassium)

Signs of low potassium levels may include weakness, irregular heartbeat or muscle cramps.

Peripheral Edema

Tresiba, like other insulin medications, may cause sodium retention and edema. In clinical studies, it was reported that edema occurred in 0.9% of patients with type 1 diabetes and 3% of patients with type 2 diabetes.

This is not the complete list of side effects. If you would like to report side effects to the FDA call 1-800-FDA-1088.

WARNING & PRECAUTIONS

To avoid dosing errors or potential overdose, never extract insulin from a Tresiba FlexTouch pen using a syringe.

Let your doctor know if you have any important notes about your medical history, especially if you have/had liver or kidney disease. Inform your doctor if you have any allergies to insulin degludec or any of its ingredients.

Blood sugar levels my also be affected by stress, surgery, injury or fever. Inform your doctor as they may choose to make adjustments to your insulin treatment.

Before going into surgery, inform your doctor or dentist if you are currently taking insulin. This should also include other prescriptions, OTC medications, herbal supplements and vitamins.

If patients miss a dose, they should continue their insulin treatment as usual. Pediatric patients should consult their doctor if they miss a dose and should monitor their blood glucose levels closely.

If you are travelling across time zones you may require changing your insulin schedule. When travelling, be sure to bring extra insulin & diabetes supplies with you.

Never share Tresiba pens, needles or syringes with others, even if the needle has been changed, as it can lead to spreading infection or transmission of blood-borne pathogens.

Any changes to your insulin regiment should be done under medical supervision. You doctor may choose to make dosage adjustments to anti-diabetic or other prescription medications you are currently taking.

Do not use this medication, especially if you currently have any liver or kidney disease.

Do not use Tresiba if you are experiencing hypoglycemia (low blood sugar levels).

Hypoglycemia

Hypoglycemia (low blood sugar) is the most common side effect with any insulin, including Tresiba. Severe hypoglycemia can cause serious side effects such as seizures, be life-threatening or be fatal.

Repeated injections into the same area may result in lipodystrophy or localized cutaneous amyloidosis which can result in hypoglycemia. Patients who have injected into areas that have had lipodystrophy or amyloidosis should be instructed to change injection sites.

Since hypoglycemia can impair concentration or vision, it’s important to assess how your body handles hypoglycemia or consult your doctor whether its safe to operate heavy machinery or drive.

Limit your alcohol consumption wile taking Tresiba as it can increase your risk of hypoglycemia.

Hypokalemia

Tresiba, like other insulin products can impact potassium levels. If untreated, hypokalemia can lead ot potential risks such as ventricular arrhythmia, respiratory paralysis or even death. Patients may need to monitor potassium levels especially if using serum potassium concentrations or potassium-lowering medications.

Pregnancy & Breast feeding

If you are pregnant, your insulin regimen and diet may need to be adjusted. Since it may have potential risks, this medication should be used only when needed.. It’s important to be careful while taking insulin, therefore your doctor should customize a plan based on your individual needs.

There is no data available that Tresiba (insulin degludec) causes drug-associated side effects in pregnant women such as miscarriages or birth defects. Poorly controlled diabetes, however, can pose risks to mother and fetus.

It is unknown whether insulin passes through breast milk as similar drugs do. Consult your doctor if you are breast feeding or plan on breast feeding to find out whether it is safe.

Allergic Reactions & Hypersensitivity

Patients can experience mild to severe allergic reactions such as anaphylaxis while using Tresiba if they are allergic to one of its ingredients. If patients experience hypersensitivity they should discontinue their medication and consult their doctor.

Medication Errors

Before taking medication, patients should review the label on their medication. The Tresiba FlexTouch shows the number of units to be injected so no dose re-calculation is needed.

DRUG INTERACTIONS

There are certain medications that may cause significant interactions with Tresiba. These may include:

  • Drugs that may increase or decrease blood sugar levels:
    • beta-blockers
    • blondidine
    • lithium salts
    • penamidine
    • alcohol
  • Drugs that may blunt the sign of symptoms of hypoglycemia:
    • beta-blockers
    • clonidine
    • guanethidine
    • reserpine
  • Drugs that may increase the risk of hypoglycemia:
    • antidiabetic agents
    • ACE inhibitors
    • angiotensin II receptor blocking agents
    • disopyramide
    • fibrates
    • fluoxetine
    • monoamine
    • oxidase inhibitors
    • pentoxifylline
    • pramlintide
    • salicylates
    • somatostatin analog (e.g., octreotide)
    • sulfonamide antibiotics
    • GLP-1 receptor agonists
    • DPP-4 inhibitors
    • SGLT-2 inhibitors
  • Drugs that may decrease blood glucose lowering effects:
    • atypical antipsychotics (e.g., olanzapine and clozapine)
    • corticosteroids
    • danazol
    • diuretics
    • estrogens
    • glucagon
    • isoniazid
    • niacin
    • oral contraceptives
    • phenothiazines
    • progestogens (e.g., in oral contraceptives)
    • protease inhibitors
    • somatropin
    • sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline)
    • thyroid hormones