Tresiba FlexTouch 200 (insulin degludec)

What is the Tresiba 200 units/mL Pre-filled Pen (FlexTouch)?

It is used to treat type 1 and type 2 diabetes mellitus in adults, adolescents and children (over the age of 1).

It is available in the form of prefilled insulin pens known also as Tresiba FlexTouch Pens.

Tresiba can be used in combination with rapid-acting insulin, oral medications for diabetes and antidiabetic medications, other than insulin.

USAGE & STORAGE

Tresiba is injected subcutaneously (under the skin) once daily, at any time of the day.

Adult patients who notice they’ve missed a dose should inject their daily-dose during waking hours then continue their regular dosing schedule.

For pediatric patients, Tresiba should be taken at the same time daily. If they miss a dose they should contact their doctor and monitor blood sugar levels closely until their next dose.

Adult patients should ensure that at least 8 hours have elapsed between consecutive injections. Dose increases should be made within 3-4 days from last injection.

It’s important to note that Tresiba contains less than 1 mmol sodium (23 mg) per dose which means its essentially sodium-free.

How to store Tresiba FlexTouch U-200

Keep medication away from children and pets.

Do not use medication after the expiry date on the label or carton.

Before first use:

Store Tresiba FelxTouch pens in refrigerator between 36°F to 46°F. Keep the pen on to protect from direct light and away from freezing element.

After first use or if carried as spare:

You can carry your Tresiba FlexTouch pens with you and keep at away from light or within room temperature (not above 86°F). It can be refrigerated between 36°F to 46°F for up to 8 weeks (56 days).

Be sure to keep the cap on the pen at all times when not in use to protect it from direct light.

Do not dispose of medication in household trash or in wastewater (toilet, sink). Speak to your pharmacist about how to properly dispose of medication no longer used in order to protect the environment.

How to use Tresiba

Use medication exactly as instructed by your doctor or pharmacist. Let them know if you are unsure how to take insulin or have any questions.

• Your doctor will instruct you on:-your Tresiba dosage per day
• how and when to monitor your blood glucose levels
• flexibility in dosing schedule

Always follow your doctors instructions for dosage and timing. Use Tresiba once daily at the same time.

If you cannot take it at your scheduled time, make sure you take it within 8 hours between doses.

Let your doctor or pharmacist know if you decide to make dietary changes as this can impact your blood sugar level.

Always check medication labels before using medication. Your Tresiba® pre-filled pen should have the words “Tresiba® 200 units/mL” marked on the pen label and packaging. Tresiba® 200 units/mL packaging and labels are designed with a dark green to identify it compared to the Tresiba® 100 units/mL packaging and label which is light green.

If you suffer from poor eye sight or blind, get help from another person who is trained to administer the FlexTouch pre-filled pen. Use a magnifying glass if it helps you read the dose counter.

The strength of your Tresiba pre-filled pen dose is dialed in units and dose counter shows the number of units left to be injected. The pre-filled pen 200 units/mL can provide a dose of 2–160 units in one injection in steps of 2 units.

For patients > 65 years of age

Tresiba can be used in seniors however it’s recommended to monitor blood sugar levels frequently.

If you have liver or kidney problems

You may need to check your blood sugar levels frequently if you have existing liver or kidney problems. Let your doctor know of any existing issues such as kidney or liver issues as they may need to adjust your treatment.

Injecting Tresiba

Your doctor, pharmacist or nurse should show you how to administer your Tresiba pre-filled pen.

Do not use Tresiba:

• in insulin pumps
• if the pen was not stored correctly
• if the pen is damaged
• if the insulin is not colorless and clear

How to inject Tresiba

• Tresiba is administered by injection under the skin (subcutaneously). Do not inject into a muscle or vein.
• The best places to inject are the upper arm, thighs or front of waist (abdomen).
• Always use a new needle before every injection. Re-used needles may result in blocked dosing. Dispose of needles after every injection.
• Do not try to extract insulin using a syringe from a pen as this may result in a potential dosing error or overdose.
• Rotate injection sites to avoid skin complications such as developing skin pitting or lumps.

If you use more Tresiba then required this may result in low blood sugar or hypoglycemia.

If you forget to use Tresiba, inject at the earliest convenience. Do not inject a double dose if you discover you missed your previous dose. If you find out you’ve missed a dose, make sure that at least 8 hours separates doses.

Do not stop using Tresiba without speaking to your doctor first. Stopping your insulin medication can result in elevated blood sugar levels and potentially ketoacidosis (too much acid in blood).

SIDE EFFECTS

As with all medication, side effects can occur when taking insulin in regular dosages. Side effects can range from mild to severe. Typically most side effects last go away within a few days or weeks.

Hypoglycemia

Hypoglycemia (low blood sugar) is the most common side effect when taking insulin. It usually affects 1 in 10 people however if not treated can become serious.

If you experience low blood sugar be sure to consume a glucose tablet, sugar snack (such as hard candy, raisins, jelly beans, sugar packet) or beverage (fruit juice or non-diet soda).

If blood sugar levels drop too low, patients can lose consciousness and require a glucagon injection since they cannot take sugar orally. Inform family and friends that you have diabetes and educate them on what to do if you lose consciousness due to hypoglycemia.

If you lose consciousness they should:

• turn you on your side
• get medical assistance immediately
• not give you anything orally (food or drink)

Once you regain consciousness you should consume a sugary snack or beverage.

If you do not regain consciousness, you should be taken to the hospital or contact emergency response.

If severe low blood sugar is not treated promptly it may result in severe complications such as brain damage or even death.

Low blood sugar can result if:

• you drink alcohol
• exercise too much
• eat too little
• skip a meal

Warning signs of low blood sugar common on suddenly. These include:

• headache
• fast heartbeat
• cold sweats
• cool pale skin
• feeling sick
• tiredness
• weakness
• confusion
• anxiety
• difficulty concentrating
• tremors
• feeling hungry
• blurred vision

Measure blood sugar levels often and get rest. Wait until blood sugar levels have settled.

Let your doctor know if:

• you have lost consciousness due to low blood sugar
• have have used/received a glucagon injection
• you’ve experienced frequent episodes of low blood sugar

This may be the result of your insulin schedule/timing, diet and exercise.

Hyperglycemia (high blood sugar levels)

High blood sugar levels may result from:

• eating more and exercising less than usual
• drinking alcohol
• an infection or fever
• rationing insulin or not using enough
• skipping insulin doses
• stop using insulin without speaking ot your doctor

Symptoms of hyperglycemia may include:

• flushed skin
• feeling sleepy or tired
• thirst
• loss of appetite
• nausea or vomiting
• increased urination
• dry mouth
• fruity or acetone breath
• dry skin

These symptoms can lead to a very serious condition called ketoacidosis which is a build of acid in the blood. This happens as a result of the body breaking down fat instead of sugar. If not treated it can potentially lead to diabetic coma or even death.

If patients experience hyperglycemia thy should:

• test blood sugar levels
• test blood for ketones and urine
• get medical assistance immediately

If you experience any side effects not listed above, report them to your doctor or pharmacist. By reporting side effects you can help improve safety measures and information on this medication.

Allergic Reaction

If you are allergic to insulin or any ingredients in Tresiba, you may experience allergic reactions. Common signs of an allergic reaction include:

• suddenly feeling unwell and sweating
• rapid heartbeat and feeling dizzy
• local reactions spread to other parts of body
• difficulty breathing
• feeling sick (vomiting)

Skin changes at injection sites

If you inject repeatedly in the same area it may result in the fatty tissue shrinking (lipoatrophy) or thickening (lipohypertrophy). This usually affects 1 in 100 people. Signs of this may be lumps under the skin caused by a protein build-up called amyloidosis. Do not inject into skin that is lumpy or shrunken as this may affect the effectiveness of insulin delivery. Rotate injection sites to avoid this and to help further prevent skin changes.

Other side effects include:

Common (may affect 1 in 10 patients):

Local site reactions. Symptoms may include redness, hives, swelling and itching at the site of injection. Typically these skin changes go away after a few days. Consult your doctor if you find these skin complications persist and do not disappear after a few weeks.

Uncommon (may affect up to 1 in 100 patients)

When you first start using Tresiba your body may keep more water than usual and result in swelling around the joints. This is usually temporary.

Rare (may affect up to 1 in 1000 patients)

Tresiba can cause allergic reactions such as diarrhea, nausea, tiredness, swelling of the lips & tongue and hives.

WARNINGS & PRECAUTIONS

Consult your doctor before using Tresiba and be aware of the following:

• Hypoglycemia (low blood glucose levels) – if your blood sugar levels drop too low be sure to follow your doctors instructions
• Hyperglycemia (high blood glucose levels) – follow your doctors instructions if your blood sugar levels are too high
• Switching between insulin medications – your insulin dose may need to be adjusted if you switch brands or another type of insulin
• Ensure you are using the right type of insulin – always check the label before administering medication
• Eye disorders – fast improvements in blood sugar control may lead to potential eye disorders such as diabetic retinopathy. Consult with your doctor if you have any vision problems.

Limitations of Use

Tresiba® is not recommended for treating diabetic ketoacidosis.

Do not use Tresiba if you are allergic to insulin degludec or any of the ingredients in this medication.

Skin Changes at Injection Sites

Rotate injection sites regularly in order to avoid skin complications such as skin shrinking, thickening or developing lumps under the skin.

Injecting insulin into lumpy skin, shrunken or thickened skin may affect the effectiveness of Tresiba. Inform your doctor if you are injecting into affected areas as they may choose to recommend closely monitoring you blood glucose levels, adjust your insulin dosage and other antidiabetic medications.

Children & Adolescents

Tresiba can be used in children over the age of 1 and adolescents.

Other Medications & Tresiba

Inform your doctor if you are currently taking any other prescription medications, over-the-counter drugs, herbal supplements or vitamins. These may affect glycemic levels which will require your doctor to adjust your insulin treatment.

The list below are common medications which can affect your insulin treatment.

The following may cause hypoglycemia:

• other diabetes medications (oral or injectable)
• sulfonamides, for infections
• anabolic steroids (such as testosterone)
• beta-blockers (used for high blood pressure)
• mild fever
• monoamine oxidase (MAO) inhibitors
• angiotensin converting enzyme (ACE) inhibitors
• acetylsalicylic acid (and other salicylates)

Blood glucose may rise due to the following drug interactions:

• anazol (endometriosis)
• oral contraceptives (birth control pills)
• thyroid hormones (thyroid problems)
• growth hormone (growth hormone deficiency)
• glucocorticoids (ie ‘cortisone’ for inflammation)
• sympathomimetics (ie epinephrine, salbutamol or terbutaline)
• thiazides (used for high blood pressure or water retention)
• octreotide and lanreotide (treats acromegaly) and may increase or decrease blood sugar levels.
• pioglitazone (often used to treat type 2 diabetes)

Consult your doctor immediately if you are experiencing symptoms of heart failure such as rapid weight gain, unusual shortness of breath or localized swelling (edema).

Tresiba & Alcohol Consumption

If you are consuming alcohol, you may require adjusting your insulin treatment since alcohol can cause rapid increase and decrease in blood sugar levels. It’s important to monitor blood sugar levels if you consume alcohol.

Pregnancy & Breast Feeding

It is unknown whether Tresiba affects a baby during pregnancy or breast feeding. Inform your doctor if you are pregnant, considering pregnancy, breast feeding or about to breast feed. Your doctor may choose to adjust your insulin treatment depending on the patients needs. Monitoring blood sugar levels (hypoglycemia) is extremely important as it may affect the health of both mother and baby.

Driving or operating heavy machinery

Having low blood sugar levels can affect a patients ability to concentrate. This could be dangerous if a patient driving or operating machinery. Consult with your doctor if it is safe for you to perform these activities if:

• you experience low blood sugar levels often
• you find it difficult to identify low blood sugar