ADTRALZA 150 mg PRE-FILLED SYRINGE SOLUTION FOR INJECTION

Introduction

Package Leaflet: Information for the Patient

Adtralza150mg solution for injection in pre-filled syringe

tralokinumab

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

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.

Contents of the pack

1. What is Adtralza and what is it used for
2. What you need to know before you use Adtralza
3. How to use Adtralza
4. Possible side effects
5. Storage of Adtralza
6. Contents of the pack and further 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 a key role in the occurrence of symptoms of atopic dermatitis.

Adtralza is used to treat adult and adolescent patients from 12 years of age with moderate to severe atopic dermatitis, also known as atopic eczema. Adtralza can be used alone or in combination with other medicines for atopic eczema that are applied to the skin.

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

2. What you need to know before you use 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 are unsure, consult your doctor, pharmacist, or nurse before using Adtralza.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Adtralza.

Allergic reactions

Very rarely, medicines may cause allergic reactions (hypersensitivity) and severe allergic reactions called anaphylactic reactions. While using Adtralza, you should look out for signs of these reactions (i.e., breathing problems, swelling of the face, mouth, and tongue, fainting, dizziness, feeling of dizziness (due to low blood pressure), hives, itching, and skin rash).

Stop using Adtralza and contact your doctor or seek immediate medical attention 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 infections caused by parasites. 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 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 and adolescents

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

Other medicines and Adtralza

Tell your doctor or pharmacist

• if you are using, have recently used, or might use any other medicines.
• if you have recently been given or are to be given any vaccine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. The effects of Adtralza on pregnant women are unknown; therefore, it is preferable to avoid its use during pregnancy unless your doctor advises you to use it.

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

Driving and using machines

It is unlikely that Adtralza will affect your ability to drive and use machines.

Adtralza contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 150 mg dose; this is essentially "sodium-free".

3. How to use Adtralza

Follow exactly the administration instructions of this medicine given by your doctor, pharmacist, or nurse. In case of 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 first recommended dose is 600 mg (four injections of 150 mg), followed by 300 mg (two injections of 150 mg) administered every 2 weeks. Depending on how you respond to treatment, your doctor will decide if you can be administered a dose every 4 weeks.

Adtralza is administered by an injection under your skin (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 medicine 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. The next dose should then be injected according to the established schedule.

If you stop treatment with Adtralza

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

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.

Adtralza can cause serious side effects, including allergic reactions (hypersensitivity) such as anaphylactic reactions; the signs may include:

• breathing problems
• swelling of the face, mouth, and tongue
• fainting, dizziness, feeling of dizziness (low blood pressure)
• hives
• itching
• skin rash

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

Other side 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)

Uncommon(may affect up to 1 in 100 people)

• inflammation of the eyes that can cause eye pain or decreased vision

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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. Storage of 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 carton after EXP. The expiry date is the last day of the month shown.

Store in the original package to protect from light.

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

If necessary, Adtralza can be stored at room temperature up to 25°C in the outer carton for a maximum of 14 days. Do not store above 25°C. Discard Adtralza if not used within 14 days of storage at room temperature.

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

Do not use this medicine if you notice it is cloudy, discolored, or contains particles.

Medicines should not be disposed of via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Adtralza

• The active ingredient 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 injectable preparations.

Appearance of Adtralza and Container Contents

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

Adtralza is available in single-unit containers containing 2 pre-filled syringes or in multiple containers containing 4 (2 units of 2) or 12 (6 units of 2) pre-filled syringes.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet: October 2022

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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

Instructions for Use

Adtralza

tralokinumab

Injectable Solution in Pre-filled Syringe

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

Keep these instructions for use to be able to consult them again if needed.

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.
• Do notinject Adtralza until you have been shown how to inject it correctly.
• Talk to your healthcare professional if you have any questions about how to inject Adtralza correctly.
• To receive the full dose, you must administer2injections ofAdtralza(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 shield that will automatically cover the needle after injection.
• Do notremove the needle cap until just before administering the injection.
• Do notshare or reuse 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 between 2°C and 8°C.
• Keep the Adtralza pre-filled syringes in the original container to protect them from light until you are ready to use them.
• Do notfreeze the Adtralza pre-filled syringes. Do notuse them if they have been frozen.
• Adtralza can be stored in the original container at room temperature up to 25°C for a maximum of 14 days. If you need to remove the container from the refrigerator permanently, write the date you removed it on the container and use Adtralza within 14 days. Discard the syringes if they have been out of the refrigerator for more than 14 days.

Step1: Preparation of the Adtralza Injection

1a: Gather all the necessary materials for the injection

For each dose of Adtralza, you will need:

• A flat, clean, and well-lit work surface, such as a table
• Adtralza container with 2 pre-filled syringes of Adtralza
• An alcohol swab (not included in the container)
• Cotton balls or clean gauze (not included in the container)
• A sharps container for disposal of needles (not included in the container).

1b: Remove the Adtralza pre-filled syringe from the refrigerator

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

Do not usethe 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 container on a flat surface and wait 30 minutes before injecting Adtralza, to allow the pre-filled syringes to reach room temperature (between 20°C and 25°C). This will help make the Adtralza injection more comfortable.

• Do notheat the pre-filled syringes in any way.
• Do notshake the syringes.
• Do notremove the needle cap from the pre-filled syringes until you reach step 3 and you are ready for the injection.
• Do notput the syringes back in the refrigerator once they have reached room temperature.

1d: Remove the Adtralza pre-filled syringes from the container

Remove the 2 Adtralza pre-filled syringes from the container one at a time, holding them by the middle of the body (not the plunger rod).

• Do nottouch the needle shields to avoid activating the needle shield too early.
• Do notremove the needle cap from the pre-filled syringes until you reach step 3 and 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.
• Look at the medicine through the viewing windows. The medicine should be transparent to opalescent, colorless to pale yellow.
• Do not usethe Adtralza pre-filled syringes if:
• • the expiration date on the syringes has passed
  • the medicine looks cloudy, discolored, or contains particles
  • the pre-filled syringes appear damaged or have been dropped

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

• You may see small air bubbles in the liquid. This is normal; you do not need to do anything about it.

Step2: Choosing and Preparing the Injection Site

2a: Choose the area where the injections will be administered

• You can do it in:
• • the abdominal area (abdomen)
  • the thigh
  • the upper arm, only when the caregiver administers the injections.
• Do notinject the medicine into sensitive skin, with bruises, scaly, with scars, hardened, or with eczema.
• Do notadminister the injection within 5 cm around the navel.

2b: Wash your hands and prepare the skin

• Wash your hands with water and soap.
• Clean the chosen area for the 2 injections with an alcohol swab, making a circular motion.
• • Let the area dry completely.
  • Do notblow on it or touch the cleaned area before the injection.

Step3: Injecting 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 straight off and throw it away in a sharps 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 see 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 hold a skin fold at the cleaned injection site. With the other hand, insert the needle completely into the skin at an angle of 45 to 90 degrees.

3c: Inject the medicine

Push the plunger head firmly with your thumb. You will have injected all the medicine when you can no longer push the plunger.

3d: Release and remove the needle

Lift your thumb off the plunger head. The needle will automatically retract into the body of the syringe and remain inside the body of the syringe.

• Place a cotton ball or a dry gauze 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.

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

Step4: Injection of the Second Syringe

To receive the full prescribed dose, you must administer a second injection. Take the second Adtralza pre-filled syringe and repeat steps3and5.

Note

Make sure to administer the second injectionin the same area of the body, but at a minimum distance of 3 cm from the first injection.

Step5: Disposal of Adtralza

• Discard the used Adtralza pre-filled syringes in a sharps container immediately after use.
• • Do notthrow the Adtralza pre-filled syringes away with household waste.

• If you do not have a sharps container, you can make a homemade one that:
• • is made of sturdy plastic;
  • can be closed with a tight-fitting, puncture-resistant lid, so that sharp objects do not protrude;
  • is upright and stable during use;
  • is leak-proof and
  • is properly labeled to warn of the hazardous waste it contains.
• When the puncture-resistant container is almost full, you should follow your local guidelines for the immediate disposal of sharps containers.
• Do notrecycle the puncture-resistant container.