Adtralza 300 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Adtralza 300 mg solution for injection in pre-filled pen

tralokinumab

Read all of 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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. How to store Adtralza
6. Contents of the pack and other information

1. What Adtralza is and what it is 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 development 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 medications for atopic eczema that are applied to the skin.

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

2. What you need to know before using Adtralza

Do not use Adtralza

• if you are allergic to tralokinumab or to 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

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

Allergic reactions

Very rarely, medicines can cause allergic reactions (hypersensitivity) and severe allergic reactions called anaphylactic reactions. While using Adtralza, you should watch for signs of these reactions (i.e., breathing problems, swelling of the face, mouth, and tongue, fainting, dizziness, feeling lightheaded (due to low blood pressure), hives, itching, and skin rash). Stop using Adtralza and contact your doctor or seek immediate medical help if you notice any signs of an allergic reaction. These signs are described 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 diarrhoea, gas, stomach discomfort, greasy stools, or dehydration, which could be signs of a parasitic infection. If you live in or travel to areas where such infections are common, speak with your doctor.

Eye problems

Consult your doctor if you develop new eye problems or if existing eye problems worsen, including eye pain or changes in vision.

Children

The safety and benefits of Adtralza in children under 12 years of age are currently unknown; therefore, do not administer this medicine to this population.

Other medicines and Adtralza

Inform your doctor or pharmacist

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

Pregnancy and breastfeeding

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

If applicable, 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 reduce your ability to drive or use machines.

Adtralza contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 300 mg dose; essentially “sodium-free”.

Adtralza contains polysorbate (E 433)

This medicine contains 0.2 mg of polysorbate 80 in each pre-filled syringe, equivalent to 0.1 mg/ml.

Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Adtralza

Follow exactly the instructions for administering this medicine as given by your doctor, pharmacist, or nurse. If you are unsure, consult your doctor, pharmacist, or nurse again.

Each pre-filled pen contains 300 mg of tralokinumab.

Dose of Adtralza to be administered and duration of treatment

• Your doctor will decide the dose of Adtralza you need and how long your treatment should last.
• The recommended starting 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 whether you can switch to receiving a dose every 4 weeks.

Adtralza is administered as an injection under the skin (subcutaneous injection). Your doctor or nurse and you may decide whether you can self-inject Adtralza.

Only self-inject Adtralza after your doctor or nurse has shown you how to do it correctly. A caregiver may also administer Adtralza to you after receiving appropriate 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 medicine than you should, or if you have administered the dose too soon, consult your doctor, pharmacist, or nurse.

If you forget to use Adtralza

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

Afterwards, the next dose should be administered according to the established schedule.

If you stop treatment with Adtralza

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

Stop using Adtralza and contact your doctor or seek immediate medical help if you notice any sign 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
• injection site reactions (i.e., redness, swelling)

Uncommon (may affect up to 1 in 100 people)

• inflammation of the eyes which may cause eye pain or decreased vision

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse 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 stated on the label and on the carton after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

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

If necessary, Adtralza may be stored at room temperature up to 30 °C inside the outer carton for a maximum of 14 days. Do not store above 30 °C. Discard Adtralza if not used within 14 days of storage at room temperature.

If you need to remove the container from the refrigerator permanently, write the date of removal on the container and use Adtralza within 14 days. Adtralza must not be refrigerated again during this period.

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

Medicines must not be disposed of via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Adtralza

• The active substance is tralokinumab.
• Each pre-filled pen contains 300 mg of tralokinumab in 2 ml of injectable solution.

The other components are sodium acetate trihydrate (E 262), acetic acid (E 260), sodium chloride, polysorbate 80 (E 433), and water for injections.

Appearance of Adtralza and contents of the pack

Adtralza is a solution ranging from clear to opalescent and from colourless to pale yellow, supplied in a pre-filled pen.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Responsible

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

For more information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

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

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

Instructions for use:

Adtralza 300 mg solution for injection in a pre-filled pen

tralokinumab

Read these instructions before starting to use the Adtralza pre-filled pens and each time you get a new pack, as they may contain new information. You may also consult your healthcare professional about your condition or treatment.

Keep these instructions for use so you can refer to them again if needed.

Each pre-filled pen contains 300 mg of tralokinumab.

Adtralza pre-filled pens 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 pen.
• Do not inject Adtralza until you have been shown how to administer it correctly.
• Speak with your healthcare professional if you have any questions about how to correctly inject Adtralza.
• 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 Adtralza pre-filled pen has a needle shield that will automatically cover the needle at the end of the injection.
• Do not remove the cap until immediately before administering the injection.
• Do not share or reuse Adtralza pre-filled pens.

Parts of the Adtralza pre-filled pen:

Storage of Adtralza

• Keep Adtralza and all medicines out of the sight and reach of children. Contains small parts.
• Store Adtralza pre-filled pens in the refrigerator between 2 °C and 8 °C.
• Keep Adtralza pre-filled pens in their original packaging to protect them from light until ready for use.
• Do not freeze pre-filled pens of Adtralza. Do not use if they have been frozen.
• Adtralza may be stored in the original packaging at room temperature up to 30 °C for a maximum of 14 days. If you need to remove the pack from the refrigerator permanently, write the date you removed it on the packaging and use Adtralza within 14 days. Dispose of the pens if they have been outside the refrigerator for more than 14 days.

Step 1: Preparing the Adtralza injection

1a: Gather all materials needed for the injection

For each dose of Adtralza, you will need:

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

1b: Remove the Adtralza pack from the refrigerator

• Check the expiry date (EXP) on the pack. Do not use the pre-filled pen if the expiry date has passed.
• When using the first pre-filled pen from the pack, check that the pack seal is intact. Do not use Adtralza pre-filled pens if the pack seal is broken.

Do not use Adtralza pre-filled pens that have been stored at room temperature for more than 14 days.

1c: Remove the Adtralza pre-filled pen from the pack

Remove 1 pre-filled pen from the pack. When using the first pre-filled pen, return the pack with the remaining pre-filled pen to the refrigerator.

• Do not remove the cap from the pre-filled pen until you reach step 3 and are ready for injection.

1d: Allow the Adtralza pre-filled pen to reach room temperature

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

This will help make the Adtralza injection more comfortable.

• Do not heat the pre-filled pen in any way.
• Do not shake the pre-filled pen.
• Do not return the pre-filled pen to the refrigerator once it has reached room temperature.

1e: Check the Adtralza pre-filled pen

• Make sure the label shows the correct medicine name, Adtralza.

• Check the expiry date on the label of the pre-filled pen.

• View the medicine through the inspection window. The solution should be from clear to opalescent, colourless to pale yellow.

• Small air bubbles in the liquid may be visible. This is normal; no action is required.

• Do not use the Adtralza pre-filled pen if:

• the expiry date on the pre-filled pen has passed

• the solution appears cloudy, discoloured, or contains particles

• the pre-filled pen appears damaged or has been dropped

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

Step 2: Choosing and preparing the injection site

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

• You may administer the injection in:

• the abdominal area (abdomen)

• the thigh

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

• Do not inject the medicine into skin that is tender, bruised, scaly, scarred, hardened, or affected by eczema.

• Do not administer the injection within 5 cm of the navel.

• It is recommended to use a different injection site for each new injection. Do not use the same body area two times in a row.

2b: Wash your hands and prepare the skin

• Wash your hands with water and soap.

• Clean the selected area with an alcohol wipe, using a circular motion.

• Allow the area to dry completely.

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

Step 3: Injecting Adtralza

3a: Remove the closure cap from Adtralza

Hold the pre-filled pen with one hand, and with the other, pull the closure cap straight off and dispose of it in a sharps container. At this point, the needle shield will be exposed to prevent touching the needle.

• Do not attempt to recap the pre-filled pen. This could cause the injection to start too early or damage the needle.
• Do not touch or press the needle shield with your finger. This could result in a needlestick injury.

3b: Position the Adtralza pre-filled pen on the injection site so the viewing window is visible

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

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

• Place the needle shield of the pre-filled pen flat against the skin (at a 90-degree angle) on the previously cleaned injection site. Make sure you can see the viewing window.

• Do not move the position of the pre-filled pen once the injection has started.

If the pre-filled pen is removed too early, you may see some medicine leaking from the pen. If this happens, you may not have received the full dose. Contact your doctor, pharmacist, or nurse.

3c: Press firmly on the Adtralza pre-filled pen and maintain pressure

Press firmly on the pre-filled pen and hold it in place. You will hear a “click” indicating that the injection has started, and the yellow plunger will begin to move.

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

It may take up to 15 seconds to inject the full dose.

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

Continue pressing.

3d: Continue pressing for an additional 5 seconds

After hearing the second “click”, continue to firmly press the pen against your skin for 5 seconds to ensure the full dose is delivered.

3e: Remove the Adtralza pre-filled pen

Remove the pre-filled pen from the injection site. The needle shield will slide and lock over the needle.

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

3f: Check the viewing window

Check the viewing window to make sure that 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 occurs, or if you have any other concerns, contact your doctor, pharmacist, or nurse.

Step 4: Disposal of the Adtralza pre-filled pen

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

• Do not throw the Adtralza pre-filled pen into household waste.

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

• is made of strong plastic;

• can be closed with a tight, puncture-resistant lid so that sharp items cannot protrude,

• remains upright and stable during use,

• is leak-proof, and

• is properly labeled to warn of the hazardous waste contained within.

• When the puncture-resistant container is nearly full, follow your local guidelines for the immediate disposal of sharps containers.

• Do not recycle the sharps container.