Adtralza 150 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Adtralza 150 mg solution for injection in a pre-filled syringe

tralokinumab

Read this entire 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 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 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 discomfort.

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 might 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 known as 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 dizzy (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. Talk to 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, consult your doctor.

Eye problems

Talk to 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 150 mg dose; i.e., essentially “sodium-free”.

Adtralza contains polysorbate (E 433)

This medicine contains 0.1 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 administration instructions for this medicine given 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.

Dose of Adtralza to be administered and duration of treatment

• Your doctor will decide the dose 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 whether you can switch to a dose every 4 weeks.

Adtralza is administered by 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 properly trained you to do so. A caregiver may also administer Adtralza to you after receiving appropriate 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 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 injected 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 problems
• swelling of the face, mouth, and tongue
• fainting, dizziness, lightheadedness (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
• reactions at the injection site (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 type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide further 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 packaging 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 packaging for a maximum of 14 days. Do not store above 30 °C. Discard Adtralza if not used within a maximum of 14 days of storage at room temperature.

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

Do not use this medicine if you notice that 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 that you no longer need. 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 syringe contains 150 mg of tralokinumab in 1 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 that ranges from clear to opalescent and from colourless to pale yellow, supplied in a glass pre-filled syringe with a needle protection cap.

Adtralza is available in single 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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LEO Pharma A/S

Industriparken 55

DK‑2750 Ballerup

Denmark

More information on this medicinal product is available by contacting the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium LEO Pharma N.V./S.A Tel/Tel: +32 3 740 7868	Lithuania LEO Pharma A/S Tel: +45 44 94 58 88
	Luxembourg/Luxembourg LEO Pharma N.V./S.A Tél/Tel: +32 3 740 7868
Czech Republic LEO Pharma s.r.o. Tel: +420 734 575 982	Hungary LEO Pharma Tel: +45 44 94 58 88
Denmark LEO Pharma AB Tlf: +45 70 22 49 11	Malta LEO Pharma A/S Tel: +45 44 94 58 88
Germany LEO Pharma GmbH Tel: +49 6102 2010	Netherlands LEO Pharma B.V. Tel: +31 205104141
Estonia LEO Pharma A/S Tel: +45 44 94 58 88	Norway LEO Pharma AS Tlf: +47 22514900
Greece LEO Pharmaceutical Hellas S.A. Tel: +30 212 222 5000	Austria LEO Pharma GmbH Tel: +43 1 503 6979
Spain Laboratorios LEO Pharma, S.A. Tel: +34 93 221 3366	Poland 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
Croatia Remedia d.o.o Tel: +385 1 3778 770 Ireland LEO Laboratories Ltd Tel: +353 (0) 1 490 8924	Romania LEO Pharma A/S Tel: +45 44 94 58 88 Slovenia LEO Pharma A/S Tel: +45 44 94 58 88
Iceland Vistor hf. Tel: +354 535 7000	Slovakia LEO Pharma s.r.o. Tel: + 420 734 575 982
Italy LEO Pharma S.p.A Tel: +39 06 52625500	Finland LEO Pharma Oy Tel/Tel: +358 20 721 8440
Cyprus The Star Medicines Importers Co. Ltd. Tel: +357 2537 1056	Sweden LEO Pharma AB Tel: +46 40 3522 00
Latvia LEO Pharma A/S Tel: +45 44 94 58 88

Date of the most recent review of this leaflet:

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

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

Instructions for use:

Adtralza

tralokinumab

Injectable solution in a pre-filled syringe

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

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

Each pre-filled syringe contains 150 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 syringes.
• Do not inject Adtralza until you have been shown how to do so correctly.
• Speak with your healthcare professional if you have any questions about how to inject Adtralza correctly.
• To receive the full dose, you must administer 2 injections of Adtralza (1 set of injections). It is recommended that you use a different injection site for each new set of injections.
• The pre-filled syringes of Adtralza have a needle shield that will automatically cover the needle at the end of the injection.
• Do not remove the needle cap until immediately before administering the injection.
• Do not share or reuse the pre-filled syringes of Adtralza.

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 pre-filled syringes of Adtralza in the refrigerator at 2 °C to 8 °C.
• Keep the pre-filled syringes of Adtralza in the original packaging to protect them from light until ready for use.
• Do not freeze the pre-filled syringes of Adtralza. Do not use them 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 permanently remove the pack from the refrigerator, write the date of removal on the pack and use Adtralza within 14 days. Discard the syringes 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
• Adtralza pack containing 2 pre-filled syringes of Adtralza
• An alcohol swab (not included in the pack)
• Clean gauze or cotton balls (not included in the pack)
• A sharps disposal container for needle disposal (not included in the pack).

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

• Check the expiry date (EXP) on the pack. Do not use the syringe if the expiry date has passed.
• Check that the seal on the Adtralza pack is intact. Do not use the pre-filled syringes of Adtralza if the pack seal is broken.

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

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

Place the Adtralza pack on a flat surface and wait 30 minutes before injecting Adtralza, allowing the pre-filled syringes to reach room temperature (between 20 °C and 25 °C). This will help make the injection more comfortable.

• Do not heat the pre-filled syringes in any way.
• Do not shake the syringes.
• Do not remove the needle cap from the pre-filled syringes until you reach step 3 and are ready for injection.
• Do not return the syringes to the refrigerator once they have reached room temperature.

1d: Remove the pre-filled syringes of Adtralza from the pack

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

• Do not touch the needle safety clips to avoid premature activation of the needle shield.
• Do not remove the needle cap from the pre-filled syringes until you reach step 3 and are ready for injection.

1e: Check the 2 pre-filled syringes of Adtralza

• Ensure the labels indicate the correct medicine name, Adtralza.
• Check the expiry date on the syringes.
• View the medicine through the viewing windows. The medicine should be from clear to opalescent, colourless to pale yellow.
• Do not use the pre-filled syringes of Adtralza if:
  • the expiry date on the syringes has passed
  • the medicine appears cloudy, discoloured, 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.

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

Step 2: Choosing and preparing the injection site

2a: Choose where the injections will be given

• You may administer the injection in:
  • the abdominal area (abdomen)
  • the thigh
  • the upper arm, only when the caregiver is administering the injections.
• Do not inject the medicine into sensitive, bruised, scaly, scarred, hardened, or eczematous skin.
• Do not administer the injection within 5 cm around the navel.

2b: Wash your hands and prepare the skin

• Wash your hands with soap and water.
• Clean the chosen site for the 2 injections with an alcohol swab 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 needle cap from Adtralza

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

• Do not recap the pre-filled syringes of Adtralza.
• Do not hold the plunger rod or plunger head while removing the needle cap.
• A drop of liquid at the tip of the needle may be visible. This is normal.
• Do not touch the needle or allow it to come into contact with any surface.

3b: Insert the needle

With one hand, gently pinch and hold a clean skin fold. With the other hand, insert the needle completely into the skin at an angle between 45 and 90 degrees.

3c: Inject the medicine

Firmly push the plunger head with your thumb. The medicine will be fully injected when you can no longer push the plunger.

3d: Release and remove the needle

Lift your thumb from the plunger head. The needle will automatically retract into the syringe barrel and remain inside the barrel.

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

Dispose of the used Adtralza pre-filled syringe in a sharps container. See step 5 “Disposal of Adtralza”.

Step 4: Injecting the second syringe

To receive the full prescribed dose, you must administer a second injection. Take the second pre-filled syringe of Adtralza and repeat steps 3 and 5.

Note

Make sure to administer the second injection in the same body area, but at least 3 cm away from the first injection.

Step 5: Disposal of Adtralza

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

  • Do not dispose of Adtralza pre-filled syringes in household waste.

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

  • is made of sturdy plastic;
  • has a tightly sealed, puncture-resistant lid so sharp objects do not protrude;
  • remains upright and stable during use;
  • is leak-proof; and
  • is properly labelled to warn of the hazardous waste it contains.

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

• Do not recycle the sharps container.