Tresiba 100 units/ml FlexTouch solution for injection in pre-filled pen

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tresiba 100 units/ml FlexTouch solution for injection in pre-filled pen

insulin degludec

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you personally and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Tresiba is and what it is used for
2. What you need to know before using Tresiba
3. How to use Tresiba
4. Possible side effects
5. How to store Tresiba
6. Contents of the pack and other information

1. What Tresiba is and what it is used for

Tresiba is a long-acting basal insulin called insulin degludec. It is used in adults, adolescents, and children from 1 year of age onwards to treat diabetes mellitus. Tresiba helps the body to lower blood sugar levels. It is administered once daily. If the usual administration time cannot be followed, the timing of administration may be adjusted, as Tresiba has a prolonged glucose-lowering effect (see section 3, “Flexibility in administration timing”). Tresiba may be used in combination with fast-acting insulins administered in relation to meals. In patients with type 2 diabetes mellitus, Tresiba may be used in combination with oral antidiabetic tablets or with injectable antidiabetic medicines other than insulin.

In patients with type 1 diabetes mellitus, Tresiba must always be used in combination with fast-acting insulins administered in relation to meals.

2. What you need to know before using Tresiba

Do not use Tresiba

• if you are allergic to insulin degludec or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Tresiba. It is important that you are aware of the following information:

• Low blood sugar level (hypoglycaemia) – If your blood sugar level is too low, follow the instructions in section 4.
• High blood sugar level (hyperglycaemia) – If your blood sugar level is too high, follow the instructions in section 4.
• Switching from other insulins – You may need an adjustment in your insulin dose if you switch from another type, brand, or manufacturer of insulin. Speak with your doctor.
• Use of pioglitazone together with insulin – See the “Pioglitazone” section below.
• Vision changes – A sudden improvement in blood sugar control may temporarily worsen diabetes-related vision problems. If you experience any vision problems, speak with your doctor.
• Using the correct insulin – Always check the label on your insulin before each injection to avoid confusion between different concentrations of Tresiba and with other insulins.

If you have reduced vision, see section 3.

Skin changes at the injection site

You should rotate your injection site to help prevent changes in fatty tissue, such as thickening of the skin, skin shrinkage, or lumps under the skin. Insulin may not work as well if injected into an area that is lumpy, shrunken, or thickened (see section 3 “How to use Tresiba”). Inform your doctor if you notice any changes at the injection site. Also inform your doctor if you are currently injecting into such affected areas before switching to a different injection site. Your doctor may advise you to monitor your blood sugar levels more closely and may adjust your insulin dose or the dose of your other antidiabetic medications.

Children and adolescents

Tresiba can be used in adolescents and children from 1 year of age. There is no experience with the use of Tresiba in children under 1 year of age.

Other medicines and Tresiba

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. Some medicines affect blood sugar levels, which may require changes in your insulin dose.

The following are the main medicines that may affect your insulin treatment.

Your blood sugar level may decrease (hypoglycaemia) if you take:

• other antidiabetic medicines (oral and injectable)
• sulphonamides, used to treat infections
• anabolic steroids, such as testosterone
• beta-blockers, used to treat high blood pressure. These may make it harder to recognize the warning signs of low blood sugar (see section 4 “Warning symptoms of low blood sugar”)
• acetylsalicylic acid (and other salicylates), used for pain and mild fever
• monoamine oxidase inhibitors (MAO inhibitors), used to treat depression
• angiotensin-converting enzyme (ACE) inhibitors, used to treat certain heart conditions or high blood pressure.

Your blood sugar level may increase (hyperglycaemia) if you take:

• danazol, used to treat endometriosis
• oral contraceptives (birth control pills)
• thyroid hormones, used to treat thyroid gland problems
• growth hormone, used to treat growth hormone deficiency
• glucocorticoids, such as cortisone, used to treat inflammation
• sympathomimetics, such as epinephrine (adrenaline), salbutamol, or terbutaline, used to treat asthma
• thiazides, used to treat high blood pressure or if your body retains too much fluid.

Octreotide and lanreotide: used to treat acromegaly, a rare disorder characterized by excessive production of growth hormone. These medicines may increase or decrease your blood sugar levels.

Pioglitazone: an oral antidiabetic used to treat type 2 diabetes mellitus. Some patients with long-standing type 2 diabetes mellitus and pre-existing heart disease or prior stroke who were treated with pioglitazone and insulin developed heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (oedema).

If you are in any of the above situations (or are unsure), consult your doctor, pharmacist, or nurse.

Use of Tresiba with alcohol

Drinking alcohol may alter your insulin requirement, as it can either increase or decrease your blood sugar level. Therefore, you should monitor your blood sugar level more frequently than usual.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your insulin dose may need to be adjusted during pregnancy and after childbirth. Careful control of your diabetes is necessary during pregnancy. Avoiding low blood sugar (hypoglycaemia) is especially important for your baby’s health.

Driving and using machines

Low or high blood sugar levels can affect your ability to drive or operate machinery. If your blood sugar level is too low or too high, your concentration and reaction time may be impaired. This could endanger your life or the lives of others. Ask your doctor whether you may drive if:

• you experience frequent episodes of hypoglycaemia;
• you have difficulty recognizing the signs of hypoglycaemia.

Important information about some of the ingredients of Tresiba

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How to use Tresiba

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

If you are blind or have reduced vision and cannot read the dose counter on the pen, do not use this pen without assistance. Ask for help from a person with normal vision who has been trained in the use of the prefilled pen FlexTouch.

Tresiba in the prefilled pen is available in two strengths: “Tresiba 100 units/mL” or “Tresiba 200 units/mL,” clearly indicated on the pen label and carton. Additionally, the packaging and label for Tresiba 100 units/mL are light green, while the packaging and label for Tresiba 200 units/mL are dark green with stripes and a red box highlighting the dose.

For both strengths, the required dose is selected in units. However, the dose units differ between the two Tresiba strengths.

The 100 units/mL prefilled pen can deliver a dose of 1–80 units in a single injection, in increments of 1 unit. The dose counter on the prefilled pen displays the number of insulin units to be injected. Do not perform any dose calculations.

Your doctor will decide together with you:

• how much Tresiba you need each day
• when to check your blood sugar level and whether you need a higher or lower dose.

Flexibility in administration timing

• Always follow your doctor’s instructions for use.
• Use Tresiba once daily, preferably at the same time each day.
• Occasionally, if it is not possible to use Tresiba at the same time each day, you may administer it at a different time. Ensure at least 8 hours pass between doses. There is no experience with flexible administration timing of Tresiba in children and adolescents.
• If you plan to change your usual diet, consult your doctor, pharmacist, or nurse first, as dietary changes may alter your insulin requirements.

Depending on your blood sugar levels, your doctor may adjust your dose.

When using other medications, ask your doctor whether your treatment needs adjustment.

Use in elderly patients (≥65 years)

Tresiba can be used in elderly patients. However, if you are elderly, you may need to monitor your blood sugar levels more frequently. Discuss possible dose adjustments with your doctor.

If you have renal or hepatic impairment

If you have kidney or liver problems, you may need to monitor your blood sugar levels more frequently. Discuss possible dose adjustments with your doctor.

Injecting the medicine

Before using Tresiba for the first time, your doctor or nurse will show you how to use the prefilled pen.

• Check the name and concentration on the pen label to ensure it is Tresiba 100 units/mL.

Do not use Tresiba

• in insulin infusion pumps.
• if the pen has been damaged or not stored properly (see section 5).
• if the insulin does not appear clear and colorless.

How to inject yourself

• Tresiba is injected under the skin (subcutaneous injection). Do not inject into a vein or muscle.
• The best injection sites are the front of the thigh, the upper arm, and the front of the waist (abdomen).
• Change the injection site daily within the same area to reduce the risk of developing lumps or dents in the skin (see section 4).
• Always use a new needle for each injection. Reusing needles may increase the risk of needle blockage, leading to inaccurate dosing. Dispose of the needle safely after each use.
• Do not use a syringe to withdraw solution from the pen, to avoid dosing errors and potential overdose.

Detailed instructions for use are provided on the reverse side of this leaflet.

If you use more Tresiba than you should

If you use too much insulin, your blood sugar level may become too low (hypoglycemia); see advice in section 4 “Blood sugar level too low.”

If you forget to use Tresiba

If you forget to take a dose, inject the missed dose as soon as you remember, ensuring at least 8 hours between doses. If you realize you missed a dose at the time of your next scheduled dose, do not inject a double dose; instead, take your usual daily dose.

If you stop using Tresiba

Do not stop using your insulin without consulting your doctor. Discontinuing insulin therapy may lead to very high blood sugar levels and diabetic ketoacidosis (a condition involving excessive acid in the blood); see advice in section 4 “Blood sugar level too high.”

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

When you are being treated with insulin, hypoglycaemia (blood sugar level too low) may occur very commonly (it may affect more than 1 in 10 people). It can be very serious. If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycaemia can cause brain damage and may be potentially fatal. If you experience symptoms of low blood sugar, take immediate action to raise your blood sugar level. See the advice on “Low blood sugar level”.

If you experience a severe allergic reaction (which occurs rarely) to insulin or to any of the components of Tresiba, stop using this medicine and contact your doctor immediately. Signs of a severe allergic reaction include:

• local reactions spreading to other parts of the body
• sudden feeling of being unwell with sweating
• dizziness (vomiting)
• difficulty breathing
• palpitations or feeling dizzy.

Skin changes at the injection site:

If you inject insulin in the same place repeatedly, fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy) (it may affect up to 1 in 100 people). Lumps under the skin may also occur due to accumulation of a protein called amyloid (cutaneous amyloidosis; frequency of occurrence is unknown). Insulin may not work effectively if injected into a lumpy, shrunken, or thickened area. Change your injection site regularly to help prevent these skin changes.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

Local reactions: localized reactions at the injection site may occur. Symptoms may include pain, redness, rash, swelling, and itching. These reactions usually disappear after a few days. If symptoms do not resolve within a few weeks, consult your doctor. If reactions worsen, stop treatment with Tresiba and contact your doctor immediately. For more information, see “severe allergic reaction” above.

Uncommon (may affect up to 1 in 100 people)

Joint swelling: when you start using this medicine, your body may retain more fluid than normal. This causes swelling of the ankles and other joints. This effect usually resolves quickly.

Rare (may affect up to 1 in 1,000 people)

This medicine may cause allergic reactions such as rash, swelling of the tongue and lips, diarrhoea, nausea, fatigue, and pruritus.

General effects of diabetes treatment

• Low blood sugar level (hypoglycaemia)

Low blood sugar levels may occur if you:

drink alcohol, inject too much insulin, exercise more than usual, eat too little, or skip a meal.

Warning symptoms of low blood sugar, which may appear suddenly:

headache, difficulty speaking, palpitations, cold sweat, cold and pale skin, dizziness, excessive hunger, trembling, nervousness or anxiety, unusual tiredness, weakness and drowsiness, confusion, difficulty concentrating, and temporary changes in vision.

What to do if your blood sugar level is too low

• Take glucose tablets or a sugary product such as sweets, biscuits, or fruit juice (always carry glucose tablets or sugary products with you in case you need them).
• Check your blood sugar level if possible, then rest. You may need to check your blood sugar level more than once, as recovery may be delayed, as with all basal insulins.
• Wait until symptoms of hypoglycaemia have disappeared or your blood sugar level has stabilized. Then continue your insulin treatment as usual.

What others should do if you lose consciousness

Inform people you spend time with that you have diabetes. Tell them about the possible consequences of low blood sugar, including the risk of losing consciousness.

Inform them that if you become unconscious, they should do the following:

• lay you on your side
• seek immediate medical help
• do not give you anything to eat or drink, as you could choke.

You may regain consciousness more quickly if given glucagon. Glucagon should only be administered by someone who knows how to do it.

• If glucagon is given, you should take glucose or a sugary product as soon as you regain consciousness.
• If you do not respond to glucagon treatment, you must be treated in a hospital.
• If severe hypoglycaemia is not treated, it may over time cause brain injury, which may be temporary or permanent, and may lead to death.

Talk to your doctor if:

• your blood sugar has dropped so low that you lost consciousness
• you have needed glucagon
• you have had several episodes of low blood sugar recently.

You may need to adjust the dose or frequency of your insulin injections, your diet, or your physical activity.

• High blood sugar level (hyperglycaemia)

High blood sugar levels may occur if you:

eat more or exercise less than usual, drink alcohol, have an infection or fever, do not inject enough insulin, repeatedly inject less insulin than you need, forget to inject insulin, or stop insulin treatment without talking to your doctor.

Warning symptoms of high blood sugar, which usually appear gradually:

dry and flushed skin, drowsiness or tiredness, dry mouth, fruity breath odour (acetone), increased need to urinate, thirst, loss of appetite, nausea, or vomiting.

These may be symptoms of a very serious condition called ketoacidosis. This is a build-up of acid in the blood due to the body metabolizing fat instead of sugar. If untreated, it could lead to diabetic coma and death.

What to do if your blood sugar level is too high

• Check your blood sugar level.
• Check for ketones in your urine or blood.
• Seek immediate medical help.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tresiba

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label and on the pen packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Before first use

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the freezer. Store the pen with the cap on to protect it from light.

After first use or when carried as a spare

You may carry your pre-filled Tresiba (FlexTouch) pen with you and store it at room temperature (not above 30°C) or in the refrigerator (between 2°C and 8°C) for up to 8 weeks.

Always keep the pen with the cap on when not in use to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Tresiba

• The active substance is insulin degludec. Each ml of solution contains 100 units of insulin degludec. Each pre-filled pen contains 300 units of insulin degludec in 3 ml of solution.

• The other components are glycerol, metacresol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections (see section 2).

Appearance of the product and contents of the pack

Tresiba is presented as a clear, colourless injectable solution in a pre-filled pen (300 units per 3 ml).

Pack sizes of 1 (with or without needles), 5 (without needles), and multipack of 10 (2 x 5) (without needles) 3 ml pre-filled pens. Only certain pack sizes may be marketed.

Marketing Authorization Holder

Novo Nordisk A/S
Novo Alle 1
DK-2880 Bagsvaerd, Denmark

Manufacturer

Novo Nordisk A/S
Novo Alle 1
DK-2880 Bagsvaerd
Denmark

Novo Nordisk Production SAS
45 Avenue D'Orleans
28000 Chartres
France

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

Instructions for use of Tresiba 100 units/ml FlexTouch solution for injection in pre-filled pen

Read these instructions carefully before using your FlexTouch pre-filled pen. If you do not follow the instructions carefully, you may inject too little or too much insulin, which could result in blood sugar levels that are too high or too low.

Do not use the pen without having received proper training from your doctor or nurse.

Begin by checking the pen to ensure it contains Tresiba 100 units/ml, then review the illustrations to become familiar with the different parts of the pen and the needle.

If you are blind or have reduced vision and cannot read the dose counter on the pen, do not use this pen without assistance. Seek help from a person with good eyesight who has been trained in the use of the FlexTouch pre-filled pen.

Your pen is a pre-filled insulin dosing pen containing 300 units of insulin. You can select a maximum of 80 units per dose, in increments of 1 unit. The pen is designed to be used with NovoTwist or NovoFine disposable needles up to 8 mm in length, for single use only.

Important information

Pay special attention to these notes, as they are important for the correct use of the pen.

1 Preparing the pen

• Check the name and concentration on the label of your pen to ensure it contains Tresiba 100 units/ml. This is especially important if you use more than one type of insulin. If you use the wrong type of insulin, your blood sugar level may become too high or too low.

• Remove the pen cap.

• Check that the insulin in the pen appears clear and colourless.

Look through the insulin window. If the insulin appears cloudy, do not use the pen.

• Take a new needle and remove the paper tab.

• Place the needle straight onto the pen. Screw it on tightly.

• Remove the outer needle cap and keep it for later. You will need it after the injection to remove the needle from the pen correctly.

• Remove the inner needle cap and discard it. If you try to replace it, you may accidentally prick yourself with the needle.

A drop of insulin may appear at the tip of the needle. This is normal, but you must still check the insulin flow.

Always use a new needle for each injection.

This reduces the risk of contamination, infection, insulin loss, blocked needles, and inaccurate dosing.

Never use bent or damaged needles.

2 Checking insulin flow

• Always check the insulin flow before starting.

This will help ensure you receive the full insulin dose.

• Turn the dose selector to select 2 units. Make sure a 2 appears in the dose counter.

• Hold the pen with the needle pointing upwards.

Gently tap the top of the pen several times to allow any air bubbles to rise.

• Press and hold the dose button until the dose counter returns to 0.

The 0 must align with the dose marker.

A drop of insulin should appear at the tip of the needle.

A small air bubble may remain at the needle tip, but it will not be injected.

If no drop appears, repeat steps 2A to 2C up to 6 times. If still no drop appears, change the needle and repeat steps 2A to 2C once more.

If, despite this, no drop of insulin appears, discard the pen and use a new one.

Always ensure a drop appears at the needle tip before injecting. This ensures insulin is flowing.

If no drop appears, no insulin will be injected, even if the dose counter moves. This may indicate the needle is blocked or damaged.

Always check the flow before injecting. If you do not check the flow, you may receive an insufficient or no insulin dose.

This could result in blood sugar levels that are too high.

3 Selecting the dose

• Ensure the dose counter shows 0 before starting.

The 0 must align with the dose marker.

• Turn the dose selector to select the dose you need, following your doctor’s or nurse’s instructions.

If you select the wrong dose, you can turn the dose selector forward or backward to correct it.

The pen allows selection of up to a maximum of 80 units.

The dose selector changes the number of units. Only the dose counter and dose marker show how many units you have selected for each dose.

You can select up to 80 units per dose. When less than 80 units remain in the pen, the dose counter will stop at the number of units left.

The dose selector clicks differently when turned forward, backward, or past the number of units remaining. Do not count the clicks of the pen.

Before injecting insulin, always use the dose counter and dose marker to verify how many units you have selected.

Do not count the pen clicks. If you inject the wrong dose, your blood sugar level may become too high or too low.

Do not use the insulin scale, as it only shows the approximate amount of insulin remaining in the pen.

4 Injecting the dose

• Insert the needle under the skin as instructed by your doctor or nurse.

• Ensure you can see the dose counter.

Do not touch the dose counter with your fingers. This could interrupt the injection.

• Press and hold the dose button until the dose counter returns to 0.

The 0 must align with the dose marker.

You may hear or feel a click at this point.

• Keep the needle under the skin for at least 6 seconds to ensure the full dose is delivered.

• While keeping the needle and pen straight, remove them from the skin.

If bleeding occurs at the injection site, apply light pressure with a cotton ball. Do not rub the area.

A drop of insulin may appear at the needle tip after injection. This is normal and does not affect the dose.

Always watch the dose counter to know how many units you are injecting.

The dose counter shows the exact number of units. Do not count the pen clicks. Press and hold the dose button until the dose counter returns to 0 after injection. If the dose counter stops before reaching 0, the full dose has not been delivered, which could result in blood sugar levels that are too high.

5 After the injection

• Place the needle tip into its outer cap, placed on a flat surface, without touching the needle or the outer needle cap.

• When the needle is covered, press the outer cap down firmly and carefully.

• Unscrew the needle and dispose of it carefully.

• Replace the pen cap after each use to protect the insulin from light.

Always dispose of the needle after each injection in an appropriate sharps container. This reduces the risk of contamination, infection, insulin loss, blocked needles, and inaccurate dosing. If the needle is blocked, no insulin will be injected.

When the pen is empty, discard it without the needle attached, following instructions from your doctor, nurse, pharmacist, or local authorities. Do not dispose of used needles in household waste.

Never attempt to re-cover the inner needle cap. You may prick yourself.

Always remove the needle after each injection and store your pen without a needle attached.

This reduces the risk of contamination, infection, insulin loss, blocked needles, and inaccurate dosing.

6 How much insulin remains?

• The insulin scale shows the approximate amount of insulin remaining in the pen.

• To know exactly how much insulin remains, use the dose counter:

Turn the dose selector until the dose counter stops.

If it shows 80, this means at least 80 units remain in the pen.

If it shows less than 80, the number indicates the exact number of units remaining.

• Turn the dose selector back until the dose counter shows 0.

• If you need more insulin than the remaining units in the pen, you may split the dose between two pens.

Be very careful when calculating if you split your dose.

If in doubt, inject the full dose using a new pen. If you split the dose incorrectly, you may inject too little or too much insulin, which could result in blood sugar levels that are too high or too low.

Additional important information

• Always carry the pen with you.

• Always carry a spare pen and new needles with you, in case of loss or damage.

• Always keep the pen and needles out of sight and reach of others, especially children.

• Never share the pen or needles with other people. This could cause infections.

• Never share the pen with other people. Your medicine could be harmful to their health.

• People caring for patients should exercise great care when handling used needles to reduce the risk of accidental needlestick injuries and infections.

Pen care

Handle your pen with care. Rough handling or misuse may lead to inaccurate dosing, which could result in blood sugar levels that are too high or too low.

• Do not leave the pen in the car or in any place where it could become too hot or too cold.

• Do not expose the pen to dust, dirt, or liquids.

• Do not wash, soak, or lubricate the pen. If necessary, clean it with a cloth dampened with mild detergent.

• Avoid dropping the pen or letting it hit hard surfaces.

If the pen is dropped or you suspect it may be damaged, attach a new needle and check insulin flow before injecting.

• Do not attempt to refill the pen. Once empty, it must be discarded.

• Do not attempt to repair or disassemble the pen.