Patient Information Leaflet

Adtralza150mg pre-filled syringe

tralokinumab

This medicine is subject to additional monitoring, which will help speed up the detection of any new safety information. You can contribute by reporting any side effects you may experience. The final part of section4includes information on how to report these side effects.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

1.What Adtralza is and what it is used for

2.What you need to know before using Adtralza

3.How to use Adtralza

4.Possible side effects

5.Storage of Adtralza

6. Contents of the pack and additional information

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‑13plays a key rolein 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 section6).

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

Warnings and precautions

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

Allergic reactions

In very 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, sensation 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 section4.

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 an area where these infections are common or if you travel to that area, consult your doctor.

Eye problems

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

Children and adolescents

The safety and benefits of Adtralza in children under12years 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 been given or will be given any vaccine.

Pregnancy, breastfeeding, and fertility

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 1mmol of sodium (23 mg) per dose of150mg; this 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 syringe contains 150 mg of tralokinumab.

Amount of Adtralza to be administered and duration of treatment

Recommended dose in adults and adolescents with atopic dermatitis:

• Your doctor will decide the amount of Adtralza you need and the duration of treatment.
• The recommended initial dose is 600 mg (four injections of 150 mg), followed by 300 mg (two injections of 150 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. The caregiver can also inject Adtralza after receiving proper training.

Do not shake the syringe.

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. Then, 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 using this medication, ask your doctor, pharmacist, or nurse.

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

Adtralza can 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, dizziness, feeling of low blood pressure
• Hives
• Itching
• Skin rash

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

Other Adverse Effects

Very Common(may affect more than1in every10people)

• Upper respiratory tract infections (i.e., common cold and sore throat)

Common(may affect up to1in every10people)

• Redness and itching of the eyes
• Eye infection
• Reactions at the injection site (i.e., redness, swelling)

Rare(may affect up to1in every100people)

• Inflammation of the eyes 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 that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendixV. 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 25°C in the outer packaging for a maximum period of 14 days. Do not store at a temperature higher than 25°C. Discard 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 packaging and use Adtralza within a period of 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 away through the drains 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 contains150mg of tralokinumab in1ml of injectable solution.
• The other components are sodium acetate trihydrate (E262), acetic acid (E260), sodium chloride, polisorbate80(E433), and water for injection.

Appearance of Adtralza and contents of the pack

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

Adtralza is available in single unit packs containing2pre-filled syringes or in multiple packs containing4(2packs of2) or12(6packs of2) pre-filled syringes.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Responsible Person

LEO Pharma A/S

Industriparken55

DK‑2750Ballerup

Denmark

For further information about this medicinal product, please consult the representative of the marketing authorization holder in your country:

Last update of this leaflet: October 2022

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

tralokinumab

Pre-filled syringe for injection

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

Keep these instructions for use for future reference.

Each pre-filled syringe contains150mg of tralokinumab.

The Adtralza pre-filled syringes 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 syringes.
• Noinject 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.
• For a complete dose, you must administer2injections of Adtralza (1set of injections). It is recommended that you use a different injection site for each new set of injections.
• The Adtralza pre-filled syringes have a needle protection that will automatically cover the needle at the end of the injection.
• Noremove the needle cap until just before administering the injection.
• Noshare or re-use the Adtralza pre-filled syringes.

Parts of the Adtralza pre-filled syringe:

Storage of Adtralza

• Keep Adtralza and all medicines out of the sight and reach of children.
• Store the Adtralza pre-filled syringes in the refrigerator between2°C and8°C.
• Store the Adtralza pre-filled syringes in the original pack to protect them from light until you are ready to use them.
• Nofreeze the Adtralza pre-filled syringes.Nouse them if they have been frozen.
• Adtralza can be stored in the original pack at room temperature up to25°C for a maximum of14días. If you need to take the pack out of the refrigerator permanently, write the date on the pack when you take it out and use Adtralza within 14 days. Dispose of the syringes if they have been out of the refrigerator for more than14días.

Step1: Preparation of the Adtralza injection

1a: Gather all the materials needed for the injection

For each dose of Adtralza, you will need:

• A flat, clean, and well-lit work surface, such as a table
• Adtralza pack with2pre-filled syringes of Adtralza
• Alcohol wipe (not included in the pack)
• Clean cotton balls or gauze (not included in the pack)
• Sharps container for disposing of needles (not included in the pack).

1b: Take the Adtralza pre-filled syringe pack out of the refrigerator

• Nouse the syringe if the expiration date (EXP) on the pack has passed.
• Check that the pack seal is intact.Nouse the Adtralza pre-filled syringes if the pack seal is broken.

Nouse the Adtralza pre-filled syringes that have been stored at room temperature for more than 14 days.

1c: Allow the Adtralza pre-filled syringes to reach room temperature

Leave the Adtralza pack on a flat surface and wait30minutes before injecting Adtralza, to allow the pre-filled syringes to reach room temperature (between20°C and25°C). This will help make the injection more comfortable.

• Noheat the Adtralza pre-filled syringes in any way.
• Noshake the syringes.
• Noremove the needle cap from the Adtralza pre-filled syringes until you reach step3and you are ready for the injection.
• Noput the syringes back in the refrigerator once they have reached room temperature.

1d: Remove the Adtralza pre-filled syringe from the pack

Remove the2Adtralza pre-filled syringes from the pack one by one, holding them by the middle of the body (not the plunger rod).

• Notouch the needle protection clips to avoid activating the needle protection too soon.
• Noremove the needle cap from the Adtralza pre-filled syringes until you reach step3and you are ready for the injection.

1e: Check the2Adtralza pre-filled syringes

• Make sure the labels indicate the correct name of the medicine, Adtralza.
• Check the expiration date on the syringes.
• Observe the medicine through the viewing windows. The medicine should be transparent to opalescent, colorless to pale yellow.
• Nouse the Adtralza pre-filled syringes if:
• • the expiration date on the syringes has passed
  • the medicine appears cloudy, discolored, or contains particles
  • the syringes appear damaged or have been dropped

If you cannot use the syringes, dispose of them in a sharps container and use new syringes.

• You may observe small air bubbles in the liquid. This is normal; do nothing about it.

Step2: Choose and prepare the injection site

2a: Choose the injection site

• You can do it in:
• • the abdomen
  • the thigh
  • the upper arm, only when the caregiver administers the injections.
• Noinject the medicine into sensitive skin, with hematomas, scaly, with scars, hardened, or with eczema.
• Noadminister the injection less than5cm from the navel.

2b: Wash your hands and prepare the skin

• Wash your hands with water and soap.
• Clean the chosen area for the2injections with an alcohol wipe, making a circular motion.
• • Let the area dry completely.
  • Nosigh on it or touch the cleaned area before the injection.

Step3: Inject Adtralza

3a: Remove the needle cap from Adtralza

Hold the body of the Adtralza pre-filled syringe with one hand, and with the other, pull the needle cap off and throw it away in a sharps container.

• Notry to put the needle cap back on the Adtralza pre-filled syringes.
• Nosustain the plunger rod or the plunger head while removing the needle cap.
• You may see a drop of liquid at the end of the needle. This is normal.
• Notouch the needle or let it come into contact with any surface.

3b: Insert the needle

With one hand, gently pinch and hold a fold of previously cleaned skin. With the other hand, insert the needle completely into the skin at an angle of between45and90degrees.

3c: Inject the medicine

Push the plunger firmly with your thumb. The entire medicine will have been injected when you can push the plunger no further.

3d: Release and remove the needle

Release your thumb from the plunger. The needle will automatically retract back into the body of the syringe and remain inside the syringe.

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

Dispose of the used Adtralza pre-filled syringe in a sharps container.See step5“Disposal of Adtralza”.

Step4: Inject the second syringe

For a complete dose, you must administer a second injection. Take the second Adtralza pre-filled syringe and repeat steps3and5.

Note

Make sure to administer thesecond injectionin the same area of the body, but at a minimum distance of3cm from the first one.

Step5: Disposal of Adtralza

• Dispose of the used Adtralza pre-filled syringes in a sharps container immediately after use.
• • Nodispose of the Adtralza pre-filled syringes with 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 and is resistant to punctures, so that no sharp objects protrude,
  • is upright and stable during use,
  • is leak-proof and
  • is correctly labeled to warn of the hazardous waste it contains.
• When the sharps container is almost full, you must follow the guidelines of your local area for the immediate disposal of sharps containers.
• Norecycle the puncture-resistant container.