Prospect: information for the patient

Adtralza 300 mg injectable solution in pre-filled pen

tralokinumab

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

Adtralza contains the active ingredient tralokinumab.

Tralokinumab is a monoclonal antibody (a type of protein) that blocks the action of a protein called IL-13. IL-13 plays a key role in the appearance of 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 alone or in combination with other eczema medications applied to the skin.

The use of Adtralza to treat atopic dermatitis may improve your eczema and reduce skin itching and pain associated with it.

No use Adtralza

• if you are allergic to tralokinumab or any of the other components of this medication (listed in section 6).

Consult your doctor, pharmacist, or nurse if you think you might be allergic, or if you are unsure, before using Adtralza.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Adtralza.

Allergic reactions

In rare cases, medications can cause allergic reactions (hypersensitivity) and severe allergic reactions called anaphylactic reactions. While using Adtralza, you must observe signs of these reactions (i.e., respiratory problems, facial swelling, mouth and tongue swelling, dizziness, nausea, feeling of low blood pressure, hives, itching, and skin rash). Stop using Adtralza and inform your doctor or seek medical help immediately if you notice any sign of an allergic reaction. These signs are indicated at the beginning of section 4.

Intestinal parasitic infection

Adtralza may reduce your resistance to parasite infections. Any parasitic infection should be treated before starting treatment with Adtralza. Consult your doctor if you have diarrhea, gas, stomach discomfort, greasy stools, and dehydration, which could be signs of a parasitic infection. If you live in a region where these infections are common or if you travel to that region, consult your doctor.

Eye problems

Consult your doctor if you have new or worsening eye problems, including eye pain or changes in vision.

Children

The safety and benefits of Adtralza in children under 12 years of age are unknown, so do not administer this medication to this population.

Other medications and Adtralza

Inform your doctor or pharmacist

• If you are using, have used recently, or may need to use any other medication.
• If you have recently received or will receive any vaccine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medication. The effects of Adtralza on pregnant women are unknown, so it is best to avoid its use during pregnancy unless your doctor advises you to use it.

If you proceed, you and your doctor should decide whether to breastfeed or use Adtralza. Do not do both at the same time.

Driving and operating machines

It is unlikely that Adtralza will reduce your ability to drive and operate machines.

Adtralza contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 300 mg dose; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

Each pre-filled pen contains 300 mg of tralokinumab.

Amount of Adtralza to be administered and treatment duration

• Your doctor will decide the amount of Adtralza you need and the treatment duration.
• The recommended initial dose is 600 mg (two injections of 300 mg), followed by 300 mg (one injection of 300 mg) administered every 2 weeks. Depending on your response to treatment, your doctor will decide if you can be administered a dose every 4 weeks.

Adtralza is administered by subcutaneous injection. Your doctor or nurse and you can decide if you can inject Adtralza yourself.

Inject Adtralza only after your doctor or nurse has taught you how to do it correctly. A caregiver can also inject Adtralza after receiving proper training.

Do not shake the pen.

Read the “Instructions for use” carefully before injecting Adtralza.

If you use more Adtralza than you should

If you use more medication than you should or if the dose is administered too soon, consult your doctor, pharmacist, or nurse.

If you forget to use Adtralza

If you have forgotten to inject a dose at the right time, inject Adtralza as soon as possible.

Subsequently, the next dose should be injected according to the established schedule.

If you interrupt treatment with Adtralza

Do not stop treatment with Adtralza without consulting your doctor first.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adtralza may cause severe adverse effects, including allergic reactions (hypersensitivity) such as anaphylactic reactions; symptoms may include:

• Respiratory problems
• Swelling of the face, mouth, and tongue
• Dizziness, fainting, sensation of low blood pressure
• Hives
• Itching
• Skin rash

Stop using Adtralza and contact your doctor or seek immediate medical help if you notice any signs of an allergic reaction.

Other Adverse Effects

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

• Upper respiratory tract infections (i.e., 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 (i.e., redness, swelling)

Rare(may affect up to 1 in 100 people)

• Eye inflammation that may cause eye pain or vision loss

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the packaging after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Store in the refrigerator (between 2 °C and 8 °C). Do not freeze.

If necessary, Adtralza can be stored at room temperature of up to 30 °C in the original packaging for a maximum period of 14 days. Do not store at a temperature above 30 °C. Dispose of Adtralza if it is not used within a maximum period of 14 days of storage at room temperature.

If you need to remove the packaging from the refrigerator permanently, write the date when you remove it from the refrigerator on the packaging and use Adtralza within 14 days. Adtralza should not be refrigerated again during this period.

Do not use this medication if you observe that it is cloudy, discolored, or contains particles.

Medicines should not be thrown down the drain or in the trash. Ask your doctor, pharmacist, or nurse how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Adtralza

• The active ingredient is tralokinumab.
• Each pre-filled syringe contains 300 mg of tralokinumab in 2 ml of injectable solution.
• The other components are sodium acetate trihydrate (E262), acetic acid (E260), sodium chloride, polisorbate 80 (E433), and water for injection.

Appearance of Adtralza and contents of the package

Adtralza is a transparent to opalescent, colorless to pale yellow solution, supplied in a pre-filled syringe.

Adtralza is available in single-unit packs containing 2 pre-filled syringes or in multiple packs containing 6 (3 packs of 2) pre-filled syringes.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

Instructions for use with information on how to administer Adtralza are available on the other side of this leaflet.

Instructions for use:

Adtralza 300 mg solution for injection in pre-filled syringe

tralokinumab

Read these instructions before starting to use the pre-filled syringes of Adtralza and each time you acquire a new pack, as it may include new information. You should also consult your healthcare professional about your disease or treatment.

Keep these instructions for use for future reference.

Each pre-filled syringe contains 300 mg of tralokinumab.

The pre-filled syringes of Adtralza are for single use only.

IMPORTANT INFORMATION

Important information you need to know before injecting Adtralza

• Before injecting Adtralza for the first time, your healthcare professional will show you how to prepare and inject Adtralza using the pre-filled syringe.
• Do not inject Adtralza until you have been shown how to inject it correctly.
• Speak to your healthcare professional if you have any questions about how to inject Adtralza correctly.
• To receive the full dose, you must administer 1 injection of Adtralza.
• It is recommended that you use a different injection site for each new injection.
• The pre-filled syringe of Adtralza has a needle guard that will automatically cover the needle at the end of the injection.
• Do not remove the cap until just before administering the injection.
• Do not share or re-use the pre-filled syringes of Adtralza.

Parts of the pre-filled syringe of Adtralza:

Storage of Adtralza

• Keep Adtralza and all medicines out of the sight and reach of children.
• Store the pre-filled syringes of Adtralza in the refrigerator at 2-8°C.
• Store the pre-filled syringes of Adtralza in the original pack to protect them from light until you are ready to use them.
• Do not freeze the pre-filled syringes of Adtralza.Do not use them if they have been frozen.
• Adtralza can be stored in the original pack at room temperature (up to 30°C) for a maximum of 14 days. If you need to take the pack out of the refrigerator permanently, write the date on which you take it out on the pack and use Adtralza within 14 days. Dispose of the pre-filled syringes if they have been out of the refrigerator for more than 14 days.

Step 1: Preparation of the injection of Adtralza

1a: Gather all the materials needed for the injection

To administer each dose of Adtralza, you will need:

• A flat, clean, and well-lit work surface, such as a table
• 1 pre-filled syringe of Adtralza
• Alcohol wipe (not included in the pack)
• Clean gauze or cotton balls (not included in the pack)
• A sharps container for the disposal of needles (not included in the pack).

1b: Take the Adtralza pack out of the refrigerator

• Check the expiration date (EXP) on the pack. Do not use the pre-filled syringe if the expiration date has passed.
• When you use the first pre-filled syringe from the pack, check that the pack seal is intact.Do not use the pre-filled syringes of Adtralza if the pack seal is broken.

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

1c: Remove the pre-filled syringe of Adtralza from the pack

Remove1pre-filled syringe from the pack. When you use the first pre-filled syringe, put the pack with the remaining pre-filled syringe back in the refrigerator.

• Do not remove the cap until you reach step 3 and you are ready to administer the injection.

1d: Let the pre-filled syringe of Adtralza reach room temperature

Leave the pre-filled syringe on a flat surface and wait at least 45 minutes before injecting Adtralza, to let the pre-filled syringe reach room temperature (between 20°C and 30°C).

This will help make the injection more comfortable.

• Do not heat the pre-filled syringe in any way.
• Do not shake the pre-filled syringe.
• Do not put the pre-filled syringe back in the refrigerator once it has reached room temperature.

1e: Check the pre-filled syringe of Adtralza

• Make sure the label indicates the correct name of the medicine, Adtralza.
• Check the expiration date on the label of the pre-filled syringe.
• Observe the medicine through the viewing window. The medicine should be transparent to opalescent, colorless to pale yellow.
• You may see small air bubbles in the liquid. This is normal; do nothing about it.

• Do not use the pre-filled syringe of Adtralza if:

• the expiration date on the pre-filled syringe has passed
• the medicine appears cloudy, discolored, or contains particles
• the pre-filled syringe appears damaged or has fallen

If you cannot use the pre-filled syringe, dispose of it in a sharps container and use a new pre-filled syringe.

Step 2: Choosing and preparing the injection site

2a: Choose the injection site

• You can do it in:

• the abdominal area
• the thigh
• the upper arm, only when the caregiver is administering the injection.

• Do not inject the medicine into sensitive skin, with bruises, scaly, with scars, hardened or with eczema.
• Do not administer the injection less than 5 cm from the navel.
• It is recommended that you use a different injection site for each new injection. Do not use the same body area twice in a row.

2b: Wash your hands and prepare the skin

• Wash your hands with water and soap.
• Clean the chosen area with an alcohol wipe, making a circular motion.

• Let the area dry completely.
• Do not blow on or touch the cleaned area before the injection.

Step 3: Injection of Adtralza

3a: Remove the cap from Adtralza

Hold the pre-filled syringe with one hand, and with the other, pull the cap out and throw it away in a sharps container. At this point, the needle guard will be exposed to prevent the needle from touching your skin.

• Do not try to put the cap back on the pre-filled syringe.This could cause the injection to happen too soon or damage the needle.
• Do not try to touch or press the needle guard with your finger. This could cause a needlestick injury.

3b: Place the pre-filled syringe of Adtralza on the injection site to see the viewing window

You can pinch the previously cleaned skin gently or administer the injection without pinching the skin.

Follow the instructions for healthcare professionals on how to administer the injection,

• Place the needle guard of the pre-filled syringe at skin level (90-degree angle) on the cleaned injection site that you have cleaned previously. Make sure you can see the viewing window.

• Do not change the position of the pre-filled syringe after the injection has started.

If the pre-filled syringe is withdrawn too soon, you may see some of the medicine coming out of the pre-filled syringe. If this happens, you may not have received the full dose. Call your doctor, pharmacist, or nurse.

3c: Press the pre-filled syringe of Adtralza and keep the pressure

Press the pre-filled syringe firmly and keep it in place. You will hear a“click”that will tell you that the injection has started and the yellow plunger will start moving.

The yellow plunger will move to the bottom of the viewing window as the medicine is injected.

The full dose may take up to 15 seconds to administer.

You will hear a second“click”when the yellow plunger fills the viewing window.

Keep pressing.

3d: Keep pressing for another 5 seconds

When you have heard the second“click”, keep pressing the pre-filled syringe firmly against your skin for 5 seconds to make sure you administer the full dose.

3e: Remove the pre-filled syringe of Adtralza

Remove the pre-filled syringe from the injection site. The needle guard will slide and fit into the needle.

• Place a cotton ball or a gauze pad over the injection site for a few seconds.Do not rub the injection site.
• You may see a small amount of blood or liquid at the injection site. This is normal. If necessary, cover the injection site with a small dressing.

3f: Check the viewing window

Check the viewing window to make sure all the liquid has been injected. If the yellow plunger does not cover the viewing window, you may not have received the full dose. If this happens or if you have any doubts, call your doctor, pharmacist, or nurse.

Step 4: Disposal of the used pre-filled syringe of Adtralza

• Dispose of the used pre-filled syringe of Adtralza in a sharps container immediately after use.

• Do not throw the used pre-filled syringe of Adtralza in household waste.

• If you do not have a sharps container, you can make a homemade one that:

• is made of puncture-resistant plastic;
• can be closed with a tight-fitting lid that is resistant to punctures, so that no sharp objects protrude;
• is upright and stable during use;
• is leak-proof;
• is correctly labeled to warn of the hazardous waste it contains.

• When the sharps container is almost full, you should follow the guidelines for your area for the immediate disposal of sharps containers.
• Do not recycle the sharps container.