Tresiba
insulin degludec
insulin degludec
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What Tresiba is and what it is used for
What you need to know before you use Tresiba
How to use Tresiba
Possible side effects
How to store Tresiba
Contents of the pack and other information
Tresiba is a long-acting basal insulin called insulin degludec. It is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Tresiba helps your body reduce your blood sugar level. It is used for once-daily dosing. On occasions when you cannot follow your regular dosing schedule, you can change the time of dosing because Tresiba has a long blood sugar-lowering effect (see section 3 for ‘Flexibility in dosing time’). Tresiba can be used with meal-related rapid-acting insulin products. In type 2 diabetes mellitus, Tresiba may be used in combination with tablets for diabetes or with injectable antidiabetic medicines, other than insulin.
In type 1 diabetes mellitus, Tresiba must always be used in combination with meal-related rapid-acting insulin medicines.
if you are allergic to insulin degludec or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor, pharmacist or nurse before using Tresiba. Be especially aware of the following:
Low blood sugar (hypoglycaemia) – if your blood sugar is too low, follow the guidance for low blood sugar in section 4.
High blood sugar (hyperglycaemia) – if your blood sugar is too high, follow the guidance for high blood sugar in section 4.
Switching from other insulin medicines – the insulin dose may need to be changed if you switch
from another type, brand or manufacturer of insulin. Talk to your doctor.
Pioglitazone used together with insulin, see ‘Pioglitazone’ below.
Eye disorder – fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder. If you experience eye problems, talk to your doctor.
Ensuring you use the right type of insulin – always check the insulin label before each injection to avoid accidental mix-ups between different strengths of Tresiba as well as other insulin
products.
If you have poor eyesight, please see section 3.
The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you
inject into a lumpy, shrunken or thickened area (see section 3 ‘How to use Tresiba’). Tell your doctor
if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check
your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.
Tresiba can be used in adolescents and children aged 1 year and above. There is no experience with the use of Tresiba in children below the age of 1 year.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Some medicines affect your blood sugar level, this may mean your insulin dose has to be
changed.
Listed below are the most common medicines which may affect your insulin treatment. Your blood sugar level may fall (hypoglycaemia) if you take:
other medicines for diabetes (oral and injectable)
sulfonamides, for infections
anabolic steroids, such as testosterone
beta-blockers, for high blood pressure. They may make it harder to recognise the warning signs of too low blood sugar (see section 4 ‘Warning signs of too low blood sugar’)
acetylsalicylic acid (and other salicylates), for pain and mild fever
monoamine oxidase (MAO) inhibitors, for depression
angiotensin converting enzyme (ACE) inhibitors, for some heart problems or high blood pressure.
Your blood sugar level may rise (hyperglycaemia) if you take:
danazol, for endometriosis
oral contraceptives (birth control pills)
thyroid hormones, for thyroid problems
growth hormone, for growth hormone deficiency
glucocorticoids such as ‘cortisone’, for inflammation
sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline, for asthma
thiazides, for high blood pressure or if your body keeps too much water (water retention).
Octreotide and lanreotide: used to treat a rare condition involving too much growth hormone (acromegaly). They may increase or decrease your blood sugar level.
Pioglitazone: oral antidiabetic medicine used to treat type 2 diabetes mellitus. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with
pioglitazone and insulin experienced the development of heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema).
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse.
If you drink alcohol, your need for insulin may change. Your blood sugar level may either rise or fall. You should therefore monitor your blood sugar level more often than usual.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes is needed in pregnancy. Avoiding too low blood sugar (hypoglycaemia) is particularly important for the health of your baby.
Having too low or too high blood sugar can affect your ability to drive or use any tools or machines. If your blood sugar is too low or too high, your ability to concentrate or react might be affected. This
could be dangerous to yourself or others. Ask your doctor whether you can drive if:
you often get too low blood sugar
you find it hard to recognise too low blood sugar.
This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that the medicine is essentially ‘sodium-free’.
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the FlexTouch pre-filled pen.
Tresiba in a pre-filled pen is available in two strengths. “Tresiba 100 units/mL” or “Tresiba
200 units/mL” is clearly marked on the pen label and packaging. In addition, Tresiba 100 units/mL packaging and label are light green, and Tresiba 200 units/mL packaging and label are dark green with
striping with a red box highlighting the formulation strength.
For both strengths, the needed dose is dialled in units. The dose steps, however, differ between the two strengths of Tresiba.
The pre-filled pen 100 units/mL can provide a dose of 1–80 units in one injection in steps of 1 unit. The dose counter of the pre-filled pen shows the number of units of insulin to be injected. Do not make any dose re-calculation.
how much Tresiba you will need each day
when to check your blood sugar level and if you need a higher or lower dose.
Always follow your doctor’s recommendation for dose.
Use Tresiba once each day, preferably at the same time every day.
On occasions when it is not possible to take Tresiba at the same time of the day, it can be taken at a different time of day. Make sure to have a minimum of 8 hours between the doses. There is
no experience with flexibility in dosing time of Tresiba in children and adolescents.
If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin.
Based on your blood sugar level, your doctor may change your dose.
When using other medicines, ask your doctor if your treatment needs to be adjusted.
Tresiba can be used in elderly, but if you are elderly, you may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.
If you have kidney or liver problems, you may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.
Before you use Tresiba for the first time, your doctor or nurse will show you how to use the pre-filled pen.
Check the name and strength on the label of the pen to make sure it is Tresiba 100 units/mL.
in insulin infusion pumps.
if the pen is damaged or has not been stored correctly (see section 5).
if the insulin does not appear clear and colourless.
Tresiba is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle.
The best places to inject are the front of your thighs, upper arms or the front of your waist (abdomen).
Change the place within the area where you inject each day to reduce the risk of developing
lumps and skin pitting (see section 4).
Always use a new needle for each injection. Re-use of needles may increase the risk of blocked needles leading to inaccurate dosing. Dispose of the needle safely after each use.
Do not use a syringe to remove the solution from the pen to avoid dosing errors and potential
overdose.
Detailed instructions for use are provided on the other side of this leaflet.
If you use too much insulin, your blood sugar may get too low (hypoglycaemia), see advice in section 4 ‘Too low blood sugar’.
If you forget a dose, inject the missed dose when discovering the mistake, ensuring a minimum of
8 hours between doses. If you discover that you missed your previous dose when it is time to take your next regular scheduled dose, do not inject a double dose, but resume your once-daily dosing schedule.
Do not stop using your insulin without talking to your doctor. If you stop using your insulin, this could lead to a very high blood sugar level and ketoacidosis (a condition with too much acid in the blood),
see advice in section 4 ‘Too high blood sugar’.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Hypoglycaemia (too low blood sugar) may occur very commonly with insulin treatment (may affect
more than 1 in 10 people). It can be very serious. If your blood sugar level falls too much, you may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If
you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately.
See advice in ‘Too low blood sugar’ below.
If you have a serious allergic reaction (seen rarely) to the insulin or any of the ingredients in Tresiba,
stop using this medicine and see a doctor straight away. The signs of a serious allergic reaction are:
the local reactions spread to other parts of your body
you suddenly feel unwell with sweating
you start being sick (vomiting)
you experience difficulty in breathing
you experience rapid heartbeat or feeling dizzy.
If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area. Change the injection site with each injection to help prevent these skin changes.
Other side effects include:
Local reactions: Local reactions at the place you inject yourself may occur. The signs may include: pain, redness, hives, swelling and itching. The reactions usually disappear after a few days. See your
doctor if they do not disappear after a few weeks. Stop using Tresiba and see a doctor straight away if
the reactions become serious. For more information, see ‘serious allergic reaction’ above.
Swelling around your joints: When you first start using your medicine, your body may keep more water than it should. This causes swelling around your ankles and other joints. This is usually only short-lasting.
This medicine can cause allergic reactions such as hives, swelling of the tongue and lips, diarrhoea, nausea, tiredness and itching.
Too low blood sugar (hypoglycaemia)
drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal.
Headache; slurred speech; fast heartbeat; cold sweat, cool pale skin; feeling sick, feeling very hungry; tremor or feeling nervous or worried; feeling unusually tired, weak and sleepy; feeling confused,
difficulty in concentrating; short-lasting changes in your sight.
Eat glucose tablets or another high sugar snack, like sweets, biscuits or fruit juice (always carry glucose tablets or a high sugar snack, just in case).
Measure your blood sugar if possible and rest. You may need to measure your blood sugar more than once, as with all basal insulin products improvement from the period of low blood sugar
may be delayed.
Wait until the signs of too low blood sugar have gone or when your blood sugar level has settled. Then carry on with your insulin as usual.
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood sugar gets too low, including the risk of passing out.
Let them know that if you pass out, they must:
turn you on your side
get medical help straight away
You may recover more quickly from passing out with an injection of glucagon. This can only be given by someone who knows how to use it.
If you are given glucagon, you will need sugar or a sugary snack as soon as you come round.
If you do not respond to a glucagon injection, you will have to be treated in a hospital.
If severe low blood sugar is not treated over time, it can cause brain damage. This can be short or long-lasting. It may even cause death.
your blood sugar got so low that you passed out
you have used an injection of glucagon
you have had too low blood sugar a few times recently.
This is because the dosing or timing of your insulin injections, food or exercise may need to be changed.
Too high blood sugar (hyperglycaemia)
eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin without talking to your doctor.
Flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting).
These may be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic coma and eventually death.
Test your blood sugar level.
Test your urine or blood for ketones.
Get medical help straight away.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pen label and carton, after ‘EXP’. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C). Do not freeze. Keep away from the freezing element. Keep the cap on the pen in order to protect it from light.
You can carry your Tresiba pre-filled pen (FlexTouch) with you and keep it at room temperature (not above 30°C) or in a refrigerator (2°C to 8°C) for up to 8 weeks.
Always keep the cap on the pen when you are not using it in order to protect it from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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 solution.
The other ingredients are glycerol, metacresol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections (see section 2).
Tresiba is presented as a clear and colourless solution for injection 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) pre-filled pens of 3 mL. Not all pack sizes may be marketed.
Novo Nordisk A/S Novo Allé
DK-2880 Bagsværd, Denmark
The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
If the second and third characters are P5, ZF or FG, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
If the second and third characters are T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d’Orléans, 28000 Chartres, France.
Start by checking your pen to make sure that it contains Tresiba 100 units/mL, then look at the illustrations below to get to know the different parts of your pen and needle.
Your pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin. You can select a maximum of 80 units per dose, in steps of 1 unit. Your pen is designed to be used with NovoTwist or NovoFine single-use disposable needles up to a length of 8 mm.
Important information
Pay special attention to these notes as they are important for correct use of the pen.
FlexTouch
Look through the insulin window. If the insulin looks cloudy, do not use the pen.
B
C
D
E
A drop of insulin may appear at the needle tip. This is normal, but you must still check the insulin flow.
F
Always use a new needle for each injection.
This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Never use a bent or damaged needle.
Turn the dose selector to select 2 units. Make sure the dose counter shows 2.
A
Hold the pen with the needle pointing up.
B
The 0 must line up with the dose pointer.
A drop of insulin should appear at the needle tip.
C
A small air bubble may remain at the needle tip, but it will not be injected.
Always make sure that a drop appears at the needle tip before you inject. This makes sure that the insulin flows.
If no drop appears, you will not inject any insulin, even though the dose counter may move. This may indicate a blocked or damaged needle.
Always check the flow before you inject. If you do not check the flow, you may get too little insulin or no insulin at all. This may lead to too high blood sugar level.
The 0 must line up with the dose pointer.
If you select a wrong dose, you can turn the dose selector forwards or backwards to the correct dose. The pen can dial up to a maximum of 80 units.
A
The dose selector changes the number of units. Only the dose counter and dose pointer will show how many units you select per dose.
You can select up to 80 units per dose. When your pen contains less than 80 units, the dose counter stops at the number of units left.
The dose selector clicks differently when turned forwards, backwards or past the number of units left. Do not count the pen clicks.
Always use the dose counter and the dose pointer to see how many units you have selected before injecting the insulin.
Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may get too high or too low.
Do not use the insulin scale, it only shows approximately how much insulin is left in your pen.
Do not touch the dose counter with your fingers. This could interrupt the injection.
The 0 must line up with the dose pointer. You may then hear or feel a click.
A
If blood appears at the injection site, press lightly with a cotton swab. Do not rub the area.
B
You may see a drop of insulin at the needle tip after injecting. This is normal and does not affect your dose.
Always watch the dose counter to know how many units you inject.
The dose counter will show the exact number of units. Do not count the pen clicks. Hold the dose button down until the dose counter returns to 0 after the injection. If the dose counter stops
before it returns to 0, the full dose has not been delivered, which may result in too high blood
sugar level.
A
Once the needle is covered, carefully push the outer needle cap completely on.
B
C
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities. Do not place the used needle in household waste.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Always remove the needle after each injection and store your pen without the needle attached.
This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
The insulin scale shows you approximately how much insulin is left in your pen.
A
If it shows 80, at least 80 units are left in your pen.
If it shows less than 80, the number shown is the number of units left in your pen.
B
Turn the dose selector back until the dose counter shows 0.
If you need more insulin than the units left in your pen, you can split your dose between two pens.
Be very careful to calculate correctly if splitting your dose.
If in doubt, take the full dose with a new pen. If you split the dose wrong, you will inject too little or too much insulin, which can lead to too high or too low blood sugar level.
Further important information
Always keep your pen and needles out of sight and reach of others, especially children.
Caregivers must be very careful when handling used needles to reduce the risk of needle injury and cross-infection.
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
If you drop it or suspect a problem, attach a new needle and check the insulin flow before you inject.