Xultophy

Основна информация

  • Търговско наименование:
  • Xultophy
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Xultophy
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Drugs used in diabetes,
  • Терапевтична област:
  • Diabetes Mellitus, Type 2
  • Терапевтични показания:
  • Xultophy is indicated for the treatment of adults with type-2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control.
  • Каталог на резюме:
  • Revision: 13

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/002647
  • Дата Оторизация:
  • 18-09-2014
  • EMEA код:
  • EMEA/H/C/002647
  • Последна актуализация:
  • 07-05-2020

Доклад обществена оценка

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United Kingdom

An agency of the European Union

Telephone

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Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

EMA/301016/2018

EMEA/H/C/002647

Xultophy (insulin degludec / liraglutide)

An overview of Xultophy and why it is authorised in the EU

What is Xultophy and what is it used for?

Xultophy is a medicine that is used for the treatment of type 2 diabetes. Together with diet and

exercise, Xultophy is added to treatment with diabetes medicines taken by mouth when these

medicines, alone or with other injections, have not controlled blood glucose (sugar) levels.

The active substances in Xultophy are insulin degludec and liraglutide.

How is Xultophy used?

Xultophy is available as pre-filled disposable pens and can only be obtained with a prescription. It is

given as an injection under the skin of the thigh, the upper arm or the abdomen (belly). The site of

injection should be changed with each injection to avoid changes to the skin (such as thickening) that

can make the medicine work less well than expected. Patients can inject themselves with Xultophy if

they have been trained appropriately.

Xultophy is given once a day, preferably at the same time each day. The dose is adjusted individually

for each patient, and the patient’s blood glucose should be regularly tested to find the lowest effective

dose.

For more information about using Xultophy, see the package leaflet or contact your doctor or

pharmacist.

How does Xultophy work?

Type 2 diabetes is a disease in which the body does not produce enough insulin to control the level of

blood glucose, or the body is unable to use insulin effectively. One of the active substances in

Xultophy, insulin degludec, is a replacement insulin that acts in the same way as naturally produced

insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the

symptoms and complications of diabetes are reduced. Insulin degludec is slightly different from human

insulin as it is absorbed more slowly and regularly by the body after an injection and it works for a long

time.

Xultophy (insulin degludec / liraglutide)

EMA/301016/2018

Page 2/3

The other active substance in Xultophy, liraglutide, belongs to the class of diabetes medicines known

as GLP-1 agonists. It acts in the same way as incretins (hormones produced in the gut) by increasing

the amount of insulin that the pancreas releases in response to food. This helps with the control of

blood glucose levels.

What benefits of Xultophy have been shown in studies?

Once-daily injection of Xultophy has been shown to be of benefit in controlling blood glucose in three

main studies involving 2,514 patients with type 2 diabetes. In all studies, the main measure of

effectiveness was the change after 6 months of treatment in the level in the blood of a substance

called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is

controlled.

The first study involved 1,663 patients whose diabetes was not adequately controlled with the

diabetes medicines metformin or metformin and pioglitazone taken by mouth. Adding Xultophy to

their treatment was compared with adding either of its active substances, insulin degludec or

liraglutide. The average HbA1c level, which was 8.3% at the start, fell to 6.4% after 26 weeks of

treatment with Xultophy, compared with 6.9% and 7.0% respectively with insulin degludec and

liraglutide.

The second study involved 413 patients whose blood glucose was not adequately controlled by

insulin and metformin with or without other diabetes medicines taken by mouth. Treatment with

Xultophy and metformin was compared with treatment using insulin degludec and metformin.

Average HbA1c at the start was 8.7% in the Xultophy group, and fell after 26 weeks of treatment

to 6.9%. In the group using insulin degludec it fell from 8.8% to 8.0%.

The third study involved 438 patients whose blood glucose was not adequately controlled by a

combination of a GLP-1 agonist (liraglutide or exenatide) and metformin with or without other

diabetes medicines taken by mouth. Patients in the study either continued with their current

treatment or received Xultophy instead of the GLP-1 agonist. Average HbA1c was 7.8% before

patients started to receive Xultophy, and fell after 26 weeks of treatment to 6.4%. In the group

that kept on receiving the GLP-1 agonist, it fell from 7.7% to 7.4%.

The majority of patients treated with Xultophy in these studies achieved control of their blood glucose

(HbA1c below 7.0%) and many achieved HbA1c below 6.5%.

What are the risks associated with Xultophy?

The most common side effect with Xultophy (which may affect more than 1 in 10 people) is

hypoglycaemia (low blood glucose). Side effects on the digestive system occurred in up to 1 in 10

patients and included nausea (feeling sick), diarrhoea, vomiting, constipation, dyspepsia (indigestion),

gastritis (inflammation of the stomach), abdominal pain (stomach ache), flatulence (wind),

gastroesophageal reflux disease (passage of stomach acid back up towards the mouth), and distension

(swelling) of the belly. For the full list of side effects and restrictions with Xultophy, see the package

leaflet.

Why is Xultophy approved?

The European Medicines Agency decided that Xultophy’s benefits are greater than its risks and it can

be authorised for use in the EU. Adding this medicine to other diabetes medicines offers better control

of blood glucose and having an alternative treatment option is valuable in individualising treatment.

Xultophy (insulin degludec / liraglutide)

EMA/301016/2018

Page 3/3

What measures are being taken to ensure the safe and effective use of

Xultophy?

The company that markets Xultophy will provide educational materials for healthcare professionals,

explaining how to use the medicine safely, so as to reduce the risk of medication errors.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Xultophy have also been included in the summary of product characteristics and

the package leaflet.

As for all medicines, data on the use of Xultophy are continuously monitored. Side effects reported

with Xultophy are carefully evaluated and any necessary action taken to protect patients.

Other information about Xultophy

Xultophy received a marketing authorisation valid throughout the EU on 18 September 2014.

Further information on Xultophy can be found on the Agency’s website: ema.europa.eu/Find

medicine/Human medicines/European public assessment reports.

This overview was last updated in 05-2018.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Xultophy 100 units/mL + 3.6 mg/mL solution for injection

insulin degludec + liraglutide

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

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 is in this leaflet

What Xultophy is and what it is used for

What you need to know before you use Xultophy

How to use Xultophy

Possible side effects

How to store Xultophy

Contents of the pack and other information

1.

What Xultophy is and what it is used for

What Xultophy is used for

Xultophy is used to improve blood glucose (sugar) levels in adult patients with type 2 diabetes

mellitus. You have diabetes because your body:

does not make enough insulin to control the level of sugar in your blood or

is not able to use the insulin properly.

How Xultophy works

Xultophy contains two active substances that help your body control your blood sugar:

insulin degludec – a long-acting basal insulin which lowers your blood sugar levels.

liraglutide – a ‘GLP-1 analogue’ that helps your body make more insulin during meals and

lowers the amount of sugar made by your body.

Xultophy and oral medicines for diabetes

Xultophy is used with oral medicines for diabetes (such as metformin, pioglitazone and sulfonylurea

medicines). It is prescribed when these medicines (used alone or with GLP-1 treatment or with basal

insulin) are not enough to control your blood sugar levels.

If you use GLP-1 treatment

You should stop your GLP-1 treatment prior to starting on Xultophy.

If you use basal insulin

You should stop your basal insulin treatment prior to starting on Xultophy.

2.

What you need to know before you use Xultophy

Do not use Xultophy:

if you are allergic to insulin degludec or liraglutide or any of the other ingredients of this

medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Xultophy.

If you are also taking a sulfonylurea (such as glimepiride or glibenclamide), your doctor may

tell you to lower your sulfonylurea dose depending on your blood sugar levels.

Do not use Xultophy if you have type 1 diabetes mellitus or if you have ‘ketoacidosis’ (a

condition with a build-up of acid in the blood).

The use of Xultophy is not recommended in patients with inflammatory bowel disease or

delayed gastric emptying (diabetic gastroparesis).

Be especially aware of the following when using Xultophy:

low blood sugar (hypoglycaemia) – if your blood sugar is low, follow the advice in section 4

‘Low blood sugar (hypoglycaemia)’.

high blood sugar (hyperglycaemia) – if your blood sugar is high, follow the advice in section 4

‘High blood sugar (hyperglycaemia)’.

Ensuring you use the right medicine – Always check the pen label before each injection to avoid

accidentally confusing Xultophy with other products.

Important things to know before you use this medicine:

Tell your doctor if you:

have eye problems. Fast improvements in blood sugar control may make diabetic eye problems

get worse for a short time. The long-term improvements in blood sugar control may ease the eye

problems.

have or have had a thyroid disease.

Important things to know while you are using this medicine:

if you have a severe stomach ache which does not go away, tell your doctor – this could be a

sign of inflamed pancreas (acute pancreatitis).

dehydration (loss of fluids from the body) can happen if you are feeling or being sick (nausea or

vomiting) or have diarrhoea – it is important to drink plenty of fluids to stop dehydration.

Children and adolescents

Do not give this medicine to children or adolescents. There is no experience with Xultophy in children

and adolescents under 18 years old.

Other medicines and Xultophy

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 Xultophy dose has to

change.

Listed below are the most common medicines, which may affect your Xultophy treatment.

Your blood sugar level may fall if you take:

other medicines for diabetes (tablets or injections)

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 low blood sugar (see section 4 ‘Warning signs of low blood sugar – these may come on

suddenly’)

acetylsalicylic acid (and medicines called ‘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 if you take:

danazol – medicine affecting ovulation

oral contraceptives – birth control pills

thyroid hormones – for thyroid disease

growth hormone – for low levels of growth hormone

medicines called ‘glucocorticoids’ such as cortisone – for inflammation

medicines called ‘sympathomimetics’ such as epinephrine (adrenaline), salbutamol or

terbutaline – for asthma

water tablets called ‘thiazides’ – for high blood pressure or if your body is holding onto too

much water (water retention).

Octreotide and lanreotide

– used for treatment of acromegaly (a rare illness with too much growth

hormone). They may increase or decrease your blood sugar level.

Pioglitazone

– tablets used for the treatment of 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 straight

away if you experience signs of heart failure such as unusual shortness of breath or rapid increase in

weight or localised swelling (oedema).

Warfarin or other blood thinners

– medicines used to prevent clotting of the blood. Tell your doctor

if you are taking warfarin or other blood thinners as you might need to have blood tests more often to

measure how thick your blood is (called ‘International Normalised Ratio’ or INR test).

Xultophy with alcohol

If you drink alcohol, your need for Xultophy may change. Your blood sugar level may either rise or

fall. You should therefore monitor your blood sugar level more often than usual.

Pregnancy and breast-feeding

Do not use Xultophy if you are pregnant or plan to become pregnant. Tell your doctor if you are

pregnant, think you might be pregnant or are planning to have a baby. It is not known if Xultophy

affects the baby.

Do not use Xultophy if you are breast-feeding. It is not known if Xultophy passes into breast milk.

Driving and using machines

Having low or high blood sugar can affect your ability to drive or use any tools or machines. If your

blood sugar is low or 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 low blood sugar

you find it hard to recognise low blood sugar.

Important information about some of the ingredients of Xultophy

Xultophy contains less than 1 mmol sodium (23 mg) per dose. This means that the medicine is

essentially ‘sodium-free’.

3.

How to use Xultophy

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 Xultophy pre-filled

pen.

Your doctor will tell you:

how much Xultophy you will need each day

when to check your blood sugar level

how to adjust the dose.

Your dose of Xultophy is administered as ‘dose steps’. The dose counter on the pen shows the number

of dose steps.

Dosing time

Use Xultophy once each day, preferably at the same time every day. Choose a time of the day

that works best for you.

If it is not possible to use Xultophy at the same time every day, it can be used at a different time

of the day. Make sure to have a minimum of 8 hours between the doses.

You do not have to use Xultophy with a meal.

Always follow your doctor’s advice for dose and dose adjustment.

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 Xultophy.

How to handle Xultophy

Xultophy is a pre-filled dial-a-dose pen.

Xultophy is administered as ‘dose steps’. The dose counter on the pen shows the number of

dose steps.

One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide.

The maximum daily dose of Xultophy is 50 dose steps (50 units of insulin degludec and 1.8 mg

of liraglutide).

Carefully read the ‘Instructions on how to use’ on the other side of this leaflet and use the pen as

described.

Always check the pen label before you inject your medicine to ensure that you use the correct pen.

How to inject

Before you use Xultophy for the first time, your doctor or nurse will show you how to inject.

Xultophy is given as an injection under the skin (subcutaneously). 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 on the other side of this leaflet.

Do not use Xultophy:

If the pen is damaged or has not been stored correctly (see section 5).

If the liquid you can see through the pen window does not look clear and colourless.

Use in elderly patients (65 years old or over)

Xultophy can be used in elderly patients 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

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.

If you use more Xultophy than you should

If you use more Xultophy than you should, your blood sugar may get low (hypoglycaemia) or you

may feel or be sick (nausea or vomiting). If your blood sugar gets low, see the advice in section 4

‘Low blood sugar (hypoglycaemia)’.

If you forget to use Xultophy

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 take a double dose.

If you stop using Xultophy

Do not stop using Xultophy without talking to your doctor. If you stop using Xultophy this could lead

to a very high blood sugar level, see the advice in section 4 ‘High blood sugar (hyperglycaemia)’.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The

following serious side effects may happen with this medicine:

Low blood sugar (very common: may affect more than 1 in 10 people).

If your blood sugar level gets low you may pass out (become unconscious). Serious

hypoglycaemia may cause brain damage and may be life-threatening. If you have signs of low

blood sugar, take actions to increase your blood sugar level straight away. See advice in ‘Low

blood sugar (hypoglycaemia)’ further down in this section.

Serious allergic reaction (anaphylactic reaction) (not known: frequency cannot be estimated

from the available data).

If you have a serious allergic reaction to any of the ingredients in Xultophy, stop using

Xultophy and see a doctor straight away. The signs of a serious allergic reaction are:

local reactions spread to other parts of your body

you suddenly feel unwell with sweating

you have difficulty breathing

you get a fast heartbeat or feel dizzy.

Other side effects include:

Common

(may affect up to 1 in 10 people)

Lower appetite, feeling or being sick (nausea or vomiting), diarrhoea, constipation, indigestion

(dyspepsia), inflamed lining of the stomach (gastritis), stomach ache, heartburn or bloating –

these usually go away after a few days or weeks.

Injection site reactions. The signs may include bruising, bleeding, pain, redness, hives, swelling

or itching – these usually go away after a few days. See your doctor if they do not disappear

after a few weeks. Stop using Xultophy and see a doctor straight away if they become serious.

Increase of pancreatic enzymes, such as lipase and amylase.

Uncommon

(may affect up to 1 in 100 people)

Hives (red bumps on your skin that are sometimes itchy).

Allergic reactions (hypersensitivity) such as rash, itching and swelling of the face.

Dehydration (loss of fluid from the body) – it is important to drink plenty of fluids to stop

dehydration.

Belching (eructation) and wind (flatulence).

Rash.

Itching.

Skin changes where you give the injection (‘lipodystrophy’) – the fatty tissue under the skin

may shrink (‘lipoatrophy’) or get thicker (‘lipohypertrophy’). Changing the place where you

inject each time may reduce the risk of these skin changes. If you notice these skin changes, tell

your doctor or nurse. If you keep injecting in the same place, these changes can become more

severe and affect the amount of medicine your body gets from the pen.

Increased heart rate.

Gallstones.

Inflamed gallbladder.

Not known

(frequency cannot be estimated from the available data)

Inflamed pancreas (pancreatitis).

Swelling of arms or legs (peripheral oedema) – 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.

General effects from diabetes treatment

Low blood sugar (hypoglycaemia)

Low blood sugar may happen if you:

drink alcohol

exercise more than usual

eat too little or miss a meal

use too much Xultophy.

Warning signs of low blood sugar – these may come on suddenly

Headache, slurred speech, fast heartbeat, cold sweat, cool pale skin, feeling sick (nausea), feeling very

hungry, shaking, feeling nervous or worried, unusually tired, weak and sleepy or confused, difficulty

concentrating, short-lasting changes in your sight.

What to do if you get low blood sugar:

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. This is because improvement in your blood sugar may not happen straight away.

Wait until the signs of low blood sugar have gone or when your blood sugar level has settled.

Then carry on with your medicine as usual.

What others need to do if you pass out:

Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood

sugar gets 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

not

give you any food or drink – because you may choke.

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.

Talk to your doctor if:

your blood sugar got so low that you passed out

you have had an injection of glucagon

you have had low blood sugar a few times recently.

This is because the dosing of your Xultophy injections, food or exercise may need to be changed.

High blood sugar (hyperglycaemia)

High blood sugar may happen if you:

drink alcohol

exercise less than usual

eat more than usual

get an infection or a fever

have not used enough Xultophy, keep using less Xultophy than you need, forget to use

Xultophy or stop using Xultophy without talking to your doctor.

Warning signs of high blood sugar – these normally appear gradually

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.

What to do if you get high blood sugar:

Test your blood sugar level.

Test your blood or urine for ketones.

Get medical help straight away.

Reporting of side effects

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.

5.

How to store Xultophy

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.

Before opening

Store in a refrigerator (2°C to 8°C). Keep away from the freezing element. Do not freeze.

During use

Do not freeze. You can carry Xultophy with you and keep it at room temperature (no more than 30°C)

or in a refrigerator (2°C to 8°C) for up to 21 days. The product should be thrown away 21 days after

first opening.

Always keep the cap on the pre-filled 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.

6.

Contents of the pack and other information

What Xultophy contains

The active substances are insulin degludec and liraglutide. Each mL of solution contains

100 units of insulin degludec and 3.6 mg liraglutide. Each unused pre-filled pen (3 mL) contains

300 units of insulin degludec and 10.8 mg liraglutide.

The other ingredients are glycerol, phenol, zinc acetate, hydrochloric acid and sodium

hydroxide (for pH adjustment), and water for injections. See also section 2 ‘Important

information about some of the ingredients of Xultophy’ for information on sodium.

What Xultophy looks like and contents of the pack

Xultophy is a clear and colourless solution.

Pack sizes of 1, 3, 5 and a multipack containing 10 (2 packs of 5) pens of 3 mL. Not all pack sizes may

be marketed.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd, Denmark

Now turn over for information on how to use your pre-filled pen.

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu

Instructions on how to use Xultophy 100 units/mL + 3.6 mg/mL solution for injection

Please read these instructions carefully

before using your Xultophy pre-

filled pen.

Do not use the pen without proper training

from your doctor or nurse.

Start by checking your pen to

make sure that it contains Xultophy

100 units/mL + 3.6 mg/mL,

then look at the illustrations below to get to know

the different parts of your pen and needle.

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 Xultophy pre-filled pen.

Xultophy is a medicine that contains insulin degludec and liraglutide.

Xultophy is administered as ‘dose steps’.

One dose step contains 1 unit

insulin degludec + 0.036 mg liraglutide.

Your pen is a pre-filled dial-a-dose pen. It contains 3 mL of Xultophy solution.

It delivers doses from:

1 dose step

to a

maximum of

50 dose steps

(50 units insulin degludec + 1.8 mg

liraglutide)

Your pen delivers doses in increments of 1 dose step.

Do not do any conversion of your dose. The dose steps dialled equal the

number shown in the dose counter.

Your pen is designed to be used with NovoTwist or NovoFine disposable

needles up to a length of 8 mm and as thin as 32G. Needles are not included in

the pack.

Important information

Pay special attention to these notes as they are important for safe use of the

pen.

Xultophy pre-filled pen and

needle (example)

Pen cap

Outer

needle cap

Inner

needle cap

Needle

Paper tab

Pen scale

Pen window

Pen label

Dose counter

Dose pointer

Dose

button

with

smooth

surface

Dose

selector

Dose

button

1 Prepare your pen with a new needle

Check the name and coloured label

of your pen, to make sure that it

contains Xultophy.

This is especially important if you take more than one type of injectable

medicine. Taking the wrong medicine could be harmful to your health.

Pull off the pen cap.

A

Check that the solution in your pen is clear

and colourless. Look

through the pen window. If the solution looks cloudy, do not use the

pen.

B

Take a new needle,

and tear off the paper tab.

C

Push the needle straight onto the pen. Turn until it is on tight.

D

Pull off the outer needle cap and keep it for later.

You will need it

after the injection, to safely remove the needle from the pen.

E

Pull off the inner needle cap and throw it away.

If you try to put it

back on, you may accidentally stick yourself with the needle.

A drop of solution may appear at the needle tip. This is normal, but you

must still check the flow.

Do not attach a new needle

to your pen until you are ready to take your

injection.

Always use a new needle for each injection.

This may prevent blocked needles, contamination, infection and

inaccurate dosing.

Never use a bent or damaged needle.

F

2 Check the flow

Turn the dose selector to

select 2 dose steps.

Make sure the dose

counter shows 2.

The dose counter and the dose pointer show how many dose steps of

Xultophy you select.

A

2

dose steps

selected

Hold the pen with the needle pointing up.

Tap the top of the pen gently

a few times to let any air bubbles rise to

the top.

B

Press and hold in the dose button

until the dose counter returns to 0.

The 0 must line up with the dose pointer.

A drop of solution should appear at the needle tip.

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

If no drop appears,

repeat steps

2A

2C

up to 6 times. If there is still

no drop, change the needle and repeat steps

2A

2C

once more.

If a drop of solution still does not appear,

dispose of the pen and use a

new one.

Always make sure that a drop appears

at the needle tip before you

inject. This makes sure that the solution flows.

If no drop appears, you will

not

inject any medicine, even though the

dose counter may move.

This may indicate a blocked or damaged

needle.

It is important always to check the flow before you inject.

If you do

not check the flow, you may get too little medicine, or no medicine at

all. This may lead to high blood sugar level.

C

3 Select your dose

Turn the dose selector to select the dose you need.

The dose counter shows the dose in dose steps.

If you select a wrong dose, you can turn the dose selector forward or

backward to the correct dose.

The pen can dial up to a maximum of 50 dose steps.

The dose selector changes the number of dose steps.

Only the dose counter and dose pointer will show how many dose steps

you select per dose.

You can select up to 50 dose steps per dose. When your pen contains

less than 50 dose steps, the dose counter stops at the number of dose

steps left.

The dose selector clicks differently when turned forward, backward or

past the number of dose steps left. Do not count the pen clicks.

Always use the dose counter and the dose pointer to see how many

dose steps you have selected before injecting the medicine.

Do not count the pen clicks. If you select and inject the wrong dose,

your blood sugar level may get high or low.

Do not use the pen scale, it only shows approximately how much

solution is left in your pen.

A

Examples

5

dose steps

selected

24

dose steps

selected

How much solution is left?

pen scale

shows you

approximately

how much solution is left in

your pen.

A

Approx.

how much

solution is

left

To see precisely how much solution is left,

use the dose counter:

Turn the dose selector until the

dose counter stops.

If it shows 50,

at least 50

dose steps are left in your pen. If it shows

less

than 50,

the number shown is the number of dose steps left in your pen.

If you need more medicine than what is 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

wrongly, you will inject too little or too much medicine. This may make

your blood sugar level high or low.

B

Example

Dose

counter

stopped: 42

dose steps

left

4 Inject your dose

Insert the needle into your skin

as your doctor or nurse has shown

you.

Make sure you can see the dose counter.

Do not cover it with your

fingers. This could interrupt the injection.

A

Press and hold down the dose button until the dose counter shows 0.

The 0 must line up with the dose pointer. You may then hear or feel a

click.

B

Keep the needle in your skin after

the dose counter has returned to 0

count slowly to 6.

If the needle is removed earlier, you may see a stream of solution

coming from the needle tip. If so, the full dose will not be delivered, and

you should increase the frequency of checking your blood sugar level.

C

Count slowly:

1-2-3-4-5-6

Remove the needle from your skin.

If blood appears at the injection site, press lightly. Do not rub the area.

You may see a drop of solution at the needle tip after injecting. This is

normal and does not affect your dose.

Always watch the dose counter to know how many dose steps you

inject.

Hold the dose button down until the dose counter shows 0. If the

dose counter does not return to 0, the full dose has not been delivered,

which may lead to high blood sugar level.

How to identify a blocked or damaged needle?

If 0 does not appear in the dose counter after continuously

pressing the dose button, you may have used a blocked or

damaged needle.

In this case - you have

not

received

any

medicine - even though

the dose counter has moved from the original dose that you have

set.

How to handle a blocked needle?

Change the needle as described in section 5 and repeat all steps starting

with section 1: Prepare your pen with a new needle. Make sure you

select the full dose you need.

Never touch the dose counter when you inject.

This can interrupt the

injection.

D

5 After your injection

Lead the needle tip into the outer needle cap

on a flat surface without

touching the needle or the outer cap.

A

Once the needle is covered,

carefully push the outer needle cap

completely on.

Unscrew the needle

and dispose of it carefully as instructed by your

doctor or nurse.

B

Put the pen cap on

your pen after each use to protect the solution from

light.

Always dispose of the needle after each injection

to ensure the use of

a sharp needle and prevent blocked needles. If the needle is blocked,

you will

not

inject any medicine.

When the pen is empty, throw it away

without

a needle on as instructed

by your doctor, nurse, pharmacist or local authorities.

Never try to put the inner needle cap back on the needle.

You may

stick yourself with the needle.

Always remove the needle from your pen after each injection.

This may prevent blocked needles, contamination, infection, leakage of

solution and inaccurate dosing.

C

Further important information

Always keep an extra pen and new needles

, in case of loss or damage.

Always keep your pen and needles

out of sight and reach of others,

especially children.

Never share your pen

with other people. Your medicine might be

harmful to their health.

Never share

your needles

with other people. It might lead to cross-

infection.

Caregivers must

be very careful when handling used needles

– to

prevent needle injury and cross-infection.

Caring for your pen

Do not leave the pen in a car

or other place where it can get too hot or

too cold.

Do not store your pen at temperatures above 30°C.

Do not expose your pen to dust, dirt or liquid.

Do not wash, soak or lubricate your pen.

If necessary, clean it with

mild detergent on a moistened cloth.

Do not drop your pen

or knock it against hard surfaces.

If you drop it or suspect a problem, attach a new needle and check the

flow before you inject.

Do not try to refill your pen.

Once empty, it must be disposed of.

Do not try to repair your pen

or pull it apart.