ADTRALZA 150 mg Injectable Solution

Зміст інструкції

1. Adtralza 150 mg injectable solution in pre-filled syringe
   1. What is Adtralza and what is it used for
   2. What you need to know before using Adtralza
   3. How to use Adtralza
   4. Possible side effects
   5. How to store Adtralza
   6. Contents of the pack and other information
2. Adtralza

Adtralza 150 mg injectable solution in pre-filled syringe

tralokinumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. 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 only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Adtralza and what is it used for

Adtralza contains the active substance tralokinumab.
Tralokinumab is a monoclonal antibody (a type of protein) that blocks the action of a protein
called IL-13. IL-13 plays an important role as a cause of the symptoms of atopic dermatitis.
Adtralza is used to treat adult and adolescent patients aged 12 years and older with
moderate to severe atopic dermatitis, also known as atopic eczema. Adtralza can be used together
with topical medications for eczema or can be used alone.
The use of Adtralza for atopic dermatitis may improve eczema and reduce the itching associated with it
and skin pain.

2. What you need to know before using Adtralza

Do not use Adtralza:

• if you are allergic to tralokinumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, or if you are not sure, ask your doctor, pharmacist or nurse before using Adtralza.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Adtralza.

Allergic reactions
Very rarely, medicines can cause allergic reactions (hypersensitivity) and severe allergic reactions
called anaphylaxis. While using Adtralza, check if you experience signs of these
reactions (such as difficulty breathing, swelling of the face, mouth and tongue, fainting,
dizziness, feeling faint due to low blood pressure, hives, itching and
rash).
If you notice any signs of an allergic reaction, stop using Adtralza and tell your doctor or seek
immediate medical attention. These signs are listed at the beginning of section 4.
Intestinal parasitic infection
Adtralza may reduce resistance to infections caused by parasites. Any parasitic infection
must be treated before starting treatment with Adtralza. Tell your doctor if you have diarrhoea, gas,
stomach discomfort, greasy stools and dehydration, which may be signs of a parasitic
infection. If you live in a region where these infections are common, or if you travel to such areas,
tell your doctor.
Eye problems
Talk to your doctor if you develop new eye problems or a worsening of existing
ones, including eye pain or changes in vision.

Children and adolescents
Do not give this medicine to children under 12 years of age because the safety and benefits of
Adtralza are not yet known in this population.

Other medicines and Adtralza
Tell your doctor or pharmacist

• if you are taking, have recently taken or might take any other medicines
• if you have recently received a vaccination or are due to receive one.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor for advice before using this medicine. The effects of Adtralza on
pregnant women are not known; therefore, it is preferable to avoid use during pregnancy unless on
medical advice.
If applicable, you and your doctor will decide whether to breastfeed or use Adtralza. You should not do
both.

Driving and using machines
It is unlikely that Adtralza will reduce your ability to drive or operate machinery.

Adtralzacontains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 150 mg, i.e. essentially ‘sodium-free’.

3. How to use Adtralza

Use this medicine following the instructions of your doctor, pharmacist or
nurse exactly. If you have any doubts, ask your doctor, pharmacist or nurse.
Each pre-filled syringe contains 150 mg of tralokinumab.

How much Adtralza is administered and for how long
Recommended dose in adults and adolescents with atopic dermatitis:

• Your doctor will decide how much Adtralza you need to be administered and for how long.
• The recommended starting dose is 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every 2 weeks. Based on how well the medicine works, your doctor may decide to administer the dose every 4 weeks.

Adtralza is administered by an injection under the skin (subcutaneous injection). You and your
doctor or nurse must decide whether you will be able to inject Adtralza yourself.
Inject Adtralza yourself only after being trained by your doctor or nurse. Adtralza
may also be administered by a caregiver, after appropriate training.
Do not shake the syringe.
Before administering Adtralza, read the “Instructions for Use”.

If you use more Adtralza than you should
If you use more medicine than you should or if the dose was administered too early, contact your
doctor, pharmacist or nurse.

If you forget to use Adtralza
If you forget to administer a dose at the right time, administer Adtralza as soon as possible.
The next dose should be administered on the normally scheduled date.

If you stop using Adtralza
Do not stop treatment with Adtralza without first talking to your doctor.
If you have any further questions about 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.
Adtralza may cause serious side effects, including allergic reactions (hypersensitivity) such as
anaphylaxis, whose signs may include:

• breathing problems
• swelling of the face, mouth and tongue
• fainting, dizziness, feeling lightheaded (low blood pressure)
• hives
• itching
• skin rash Stop using Adtralza and see your doctor immediately or seek medical attention if you develop an allergic reaction.

Other side effects

Very common(may affect more than 1 in 10 people)

• upper respiratory tract infections (such as common cold and sore throat)

Common(may affect up to 1 in 10 people)

• redness and itching of the eyes
• eye infection
• reactions at the injection site (such as redness, swelling)

Uncommon(may affect up to 1 in 100 people)

• eye inflammation, which may cause eye pain or decreased vision

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Adtralza

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 label and on the packaging after
Expiry/EXP. The expiry date refers to the last day of that month.
Keep in the original packaging to protect the medicine from light.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
If necessary, Adtralza can be stored at room temperature up to 25 °C in the original packaging
for a maximum of 14 days. Do not store at a temperature above 25 °C. Discard
Adtralza if it is not used within 14 days of storage at room temperature.
If the pack needs to be removed permanently from the refrigerator, write on the pack itself the date on
which it was removed and use Adtralza within 14 days. Adtralza must not be returned to the
refrigerator during this period of time.
Do not use this medicine if you notice that it is cloudy, contains particles or if the colour is changed.
Do not dispose of any medicine in wastewater or household waste. Ask your doctor, your
pharmacist or your nurse how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What Adtralza contains

• The active substance is tralokinumab.
• Each pre-filled syringe contains 150 mg of tralokinumab in 1 mL of injectable solution.
• The other components are sodium acetate trihydrate (E262), acetic acid (E260), sodium chloride, polysorbate 80 (E433) and water for injections.

Description of the appearance of Adtralza and contents of the pack
Adtralza is a solution from clear to opalescent, from colourless to pale yellow, supplied in a
pre-filled glass syringe equipped with a needle shield.
Adtralza is available in packs containing 2 pre-filled syringes or in multiple packs
containing 4 (2 packs of 2) or 12 (6 packs of 2) pre-filled syringes.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
LEO Pharma N.V./S.A
Tél/Tel: +32 3 740 7868

Lietuva
LEO Pharma A/S
Tel: +45 44 94 58 88

България
LEO Pharma A/S
Teл.: +45 44 94 58 88

Luxembourg/Luxemburg
LEO Pharma N.V./S.A
Tél/Tel: +32 3 740 7868

Česká republika
LEO Pharma s.r.o.
Tel: +420 734 575 982

Magyarország
LEO Pharma A/S
Tel: +45 44 94 58 88

Danmark
LEO Pharma AB
Tlf: +45 70 22 49 11

Malta
LEO Pharma A/S
Tel: +45 44 94 58 88

Deutschland
LEO Pharma GmbH
Tel: +49 6102 2010

Nederland
LEO Pharma B.V.
Tel: +31 205104141

Eesti
LEO Pharma A/S
Tel: +45 44 94 58 88

Norge
LEO Pharma AS
Tlf: +47 22514900

Ελλάδα
LEO Pharmaceutical Hellas S.A.
Τηλ: +30 210 68 34322

Österreich
LEO Pharma GmbH
Tel: +43 1 503 6979

España
Laboratorios LEO Pharma, S.A.
Tel: +34 93 221 3366

Polska
LEO Pharma Sp. z o.o.
Tel.: +48 22 244 18 40

France
Laboratoires LEO
Tél: +33 1 3014 4000

Portugal
LEO Farmacêuticos Lda.
Tel: +351 21 711 0760

Hrvatska
LEO Pharma A/S
Tel: +45 44 94 58 88

Ireland
LEO Laboratories Ltd
Tel: +353 (0) 1 490 8924

România
LEO Pharma A/S
Tel: +45 44 94 58 88

Slovenija
LEO Pharma A/S
Tel. +45 44 94 58 88

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
LEO Pharma s.r.o.
Tel: +420 734 575 982

Italia
LEO Pharma S.p.A
Tel: +39 06 52625500

Suomi/Finland
LEO Pharma Oy
Puh/Tel: +358 20 721 8440

Κύπρος
The Star Medicines Importers Co. Ltd.
Τηλ: +357 2537 1056

Sverige
LEO Pharma AB
Tel: +46 40 3522 00

Latvija
LEO Pharma A/S
Tel: +45 44 94 58 88

United Kingdom (Northern Ireland)
LEO Laboratories Ltd
Tel: +44 (0) 1844 347333
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .

information on how to inject Adtralza.
Instructions for use:

Adtralza

tralokinumab
Solution for injection in pre-filled syringe
Read these instructions before you start using the Adtralza pre-filled syringes and each time you
receive a new pack because they may contain new information. Consult your doctor
regarding your medical condition or treatment.
Keep these instructions for use for future reference if needed.

Each pre-filled syringe contains 150 mg of tralokinumab.
Adtralza pre-filled syringes are for single use only.
IMPORTANT INFORMATION
Important information you should know before injecting Adtralza

• Before injecting Adtralza for the first time, the healthcare professional will show you how to prepare and inject Adtralza using the pre-filled syringes.
• Do notinject Adtralza until you have been shown how to inject it correctly.
• Ask your healthcare professional if you have any questions about how to inject Adtralza correctly.
• To receive the full dose, you will need to administer 2 injections of Adtralza (1 set ofinjections). It is recommended to use a different injection site for each new set ofinjections.
• Adtralza pre-filled syringes are equipped with a needle guard that will automatically cover the needle at the end of the injection.
• Do notremove the needle cap until just before you are ready to give the injection.
• Do notshare or reuse Adtralza pre-filled syringes.

Parts of the Adtralza pre-filled syringe:

Before useAfter use
How to store Adtralza

• Keep this medicine out of the sight and reach of children.
• Store Adtralza pre-filled syringes in a refrigerator at a temperature between 2 °C and 8 °C.
• Store Adtralza pre-filled syringes in the original packaging to protect the medicine from light until you are ready to use them.
• Do notfreeze Adtralza pre-filled syringes. Do notuse them if they have been frozen.
• Adtralza can be stored in its original packaging at room temperature up to 25 °C for a maximum of 14 days. If the box needs to be permanently removed from the refrigerator,

write the date it was removed on the box itself. Discard the syringes if they have been
left out of the refrigerator for more than 14 days.

Step 1: Preparing the Adtralza injection

1a. Collect the necessary materials for the injection
You will need the following for each dose of Adtralza:

• a flat, clean and well-lit work surface, such as a table
• Adtralza box with 2 Adtralza pre-filled syringes.
• an alcohol swab (not included in the box)
• clean cotton balls or gauze (not included in the box)
• a puncture-resistant sharps container (not included in the box)

1b. Remove the box of Adtralza pre-filled syringes from the refrigerator

• Check the expiration date (Exp.) on the box. Do notuse if the expiration date on the box has passed.
• Check that the seal on the Adtralza box is intact. Do notuse the Adtralza pre-filled syringes if the seal on the box is broken.

Do not usethe Adtralza pre-filled syringes if the syringes have been stored at room
temperature for more than 14 days.

min

1c. Allow the Adtralza pre-filled syringes to reach room temperature
Place the Adtralza box on the flat surface and wait 30 minutes before injecting the medicine,
to allow the pre-filled syringes to reach room temperature (20 ºC-25 ºC). This
will make injecting Adtralza more comfortable.

• Do notheat the pre-filled syringes in any way.
• Do notshake the syringes.
• Do notremove the needle cap on the syringes until you reach Step 3, when you are ready to administer the injection.
• Do notput the syringes back in the refrigerator after they have reached room temperature.

1d. Remove the Adtralza pre-filled syringes from the box
Remove the 2Adtralza pre-filled syringes from the box one at a time by holding them by the body (not
by the plunger rod).

• Do nottouch the clips of the needle guard to avoid premature activation of the safety device (needle guard).
• Do notremove the needle cap on the syringes until you reach Step 3, when you are ready to administer the injection.

1e. Inspect the 2 Adtralza pre-filled syringes

• Check that the labels show the correct medicine name, Adtralza.
• Check the expiration date on the syringes.
• Check the medicine through the inspection windows. The medicine should be from clear to opalescent, from colorless to light yellow.
• Do not use the Adtralza pre-filled syringes if: o the expiration date on the syringes has passed o the medicine is cloudy, contains particles, or if the color is altered

o the pre-filled syringes appear damaged or have been dropped
If you cannot use the syringes, dispose of them in a puncture-resistant container and use new syringes.

• You may notice air bubbles in the liquid. This is normal. No action is required.

Step 2. Choosing and preparing the injection site

2a. Choose the injection site

• You can administer the injections: o in the abdominal area (abdomen) o in the thighs o in the upper arm. Injections in the upper arm should be administered by someone assisting the patient.
• Do notinject into areas where the skin is sore or bruised, scaly, scarred, injured, hardened or has eczema.
• Do notinject within 5 cm around the navel.

2b. Wash your hands thoroughly and prepare the skin

• Wash your hands with soap and water.
• Clean the injection area for both injections with an alcohol swab using a circular motion. o Allow the area to dry completely. o Do notblow or touch the cleaned area before administering the injection.

Step 3. Injecting Adtralza

3a. Remove the needle cap from Adtralza
Hold the body of the Adtralza pre-filled syringe with one hand, use the other hand to
remove the needle cap and discard it in the puncture-resistant container.

• Do nottry to recap the Adtralza pre-filled syringes.
• Do nothold the plunger rod or the plunger head while removing the needle cap.
• You may notice a drop of liquid at the end of the needle. This is normal.
• Do nottouch the needle or let it come into contact with any surface.

3b. Insert the needle
With one hand, gently pinch and lift a fold of skin in the cleaned injection area.
With the other hand, insert the needle completely into the skin, at an angle of 45-90 degrees.

3c. Inject the medicine
Use your thumb to push the plunger head firmly all the way down. The medicine will have been
injected completely when you can no longer push the plunger head any further.

3d. Release and remove
Remove your thumb from the plunger head. The needle will automatically retract into the body of the syringe and
lock into place.

• Press a cotton ball or gauze on the injection area for a few seconds. Do not rub the injection area. If necessary, cover the injection area with a small bandage.
• There may be a small amount of blood or fluid at the injection site. This is normal. Dispose of the used Adtralza pre-filled syringe in a puncture-resistant container. SeeStep 5 “Disposing of Adtralza”.

Step 4. Injection with the second syringe

repeat
To receive the prescribed full dose, you will need to administer a second injection.
Take a new Adtralza pre-filled syringe and repeat Steps 3 and 5.
Note
Make sure that the second injectionis administered in the same area of the body, but at
least 3 cm away from the first.

Step 5. Disposing of Adtralza

• Immediately after use, place the used Adtralza pre-filled syringes in a puncture-resistant container. o Do notthrow the Adtralza pre-filled syringes into household waste.
• If you do not have a puncture-resistant container, you can use a household container that: o is made of sturdy plastic,

o can be closed with a tight, puncture-resistant lid, without
the possibility of sharp objects leaking out,
o is in an upright and stable position during use,
o is leak-proof and
o is appropriately labeled to warn that the contents consist of hazardous waste.

• When the puncture-resistant container is almost full, you will need to follow local guidelines for proper disposal.
• Do notrecycle the used sharps container.