Adtralza 150 mg solution for injection in pre-filled syringe

• 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.

1. What Adtralza^® is and what it is used for
2. What you need to know before you use Adtralza^®
3. How to use Adtralza^®
4. Possible side effects
5. How to store Adtralza^®
6. Contents of the pack and other information

• 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 you are not sure, ask your doctor, pharmacist or nurse for advice before using Adtralza.

Talk to your doctor, pharmacist or nurse before using Adtralza.

Allergic reactions

Very rarely, medicines can cause allergic (hypersensitivity) reactions and severe allergic reactions called anaphylaxis. You must look out for signs of these reactions (such as breathing problems, swelling of the face, mouth, and tongue, fainting, dizziness, feeling lightheaded (because of low blood pressure), hives, itching and skin rash) while you are using Adtralza.

Stop using Adtralza and tell your doctor or get medical help immediately if you notice any signs of an allergic reaction. Such signs are listed in the beginning of section 4.

Parasitic infection in the intestines

Adtralza may reduce your resistance to infections caused by parasites. Any parasitic infection should be treated before you start treatment with Adtralza. Tell your doctor if you have diarrhoea, gas, upset stomach, 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 are travelling to such a region, tell your doctor.

Eye problems

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

Do not give this medicine to children below the age of 12 years because the safety and benefits of Adtralza are not yet known in this population.

Tell your doctor or pharmacist

• If you are using, have recently used or might use any other medicines.
• If you have recently had a vaccination or are due to have one.

If you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby, ask your doctor for advice before using this medicine. The effects of Adtralza in pregnant women are not known; therefore, it is preferable to avoid using it during pregnancy unless your doctor advises you to use it.

If applicable, you and your doctor should decide if you will breast-feed or use Adtralza. You should not do both.

Adtralza is unlikely to reduce your ability to drive and use machines.

This medicine contains less than 1 mmol sodium (23 mg) per 150 mg that is to say essentially “sodium-free”.

• Your doctor will decide how much Adtralza you need and for how long.
• The recommended first dose is 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) given every 2 weeks. Based on how well the medicine works, your doctor may decide that you can have a dose every 4 weeks.

Adtralza is given by injection under your skin (subcutaneous injection). You and your doctor or nurse can decide if you can inject Adtralza yourself.

Inject Adtralza yourself only after you have been trained by your doctor or nurse. A caregiver may also give you your Adtralza injection after proper training.

Do not shake the syringe.

Read the “Instructions for Use” before injecting Adtralza.

If you use more of this medicine than you should or the dose has been given too early, talk to your doctor, pharmacist or nurse.

If you miss injecting a dose at the right time, inject Adtralza as soon as possible. Then the next dose should be injected at the regular scheduled time.

Do not stop using Adtralza without speaking to your doctor first.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is tralokinumab.
• Each pre-filled syringe contains 150 mg of tralokinumab in 1 mL solution for injection.
• The other ingredients are sodium acetate trihydrate (E262), acetic acid (E260), sodium chloride, polysorbate 80 (E433) and water for injections.

Adtralza is a clear to opalescent, colourless to pale yellow solution, supplied in a glass pre-filled syringe with a needle guard.

Adtralza is available in unit packs containing 2 pre-filled syringes or in multipacks containing 4 (2 packs of 2) or 12 (6 packs of 2) pre-filled syringes.

Not all pack sizes may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Important information you need to know before injecting Adtralza:

• Before you inject 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 inject it the right way.
• Talk to your healthcare professional if you have any questions about how to inject Adtralza the right way.
• To receive your full dose, you will need to have 2 Adtralza injections (1 set of injections). It is recommended that you use a different injection area for each new set of injections.
• The Adtralza pre-filled syringes have a needle guard that will automatically cover the needle after the injection is finished.
• Do not remove the needle cover until just before you give the injection.
• Do not share or reuse your Adtralza pre-filled syringes.

• Keep this medicine out of the sight and reach of children.
• Store Adtralza pre-filled syringes in a refrigerator between 2 ºC and 8 ºC.
• Store Adtralza pre-filled syringes in the original package and protect from light until you are ready to use them.
• Do not freeze Adtralza pre-filled syringes. Do not use if they have been frozen.
• Adtralza can be stored in the original package at room temperature up to 30 °C for up to 14 days. If removed permanently from the refrigerator, write down the date of removal on the carton, and use Adtralza within 14 days. Discard syringes if left out of the refrigerator for more than 14 days.

1a: Gather the supplies needed for your injection

For each Adtralza dose you will need:

• A clean, flat, well-lit work surface, like a table
• Adtralza carton with 2 Adtralza pre-filled syringes
• An alcohol swab (not included in the carton)
• Clean gauze pads or cotton balls (not included in the carton)
• A puncture-resistant sharps disposal container (not included in the carton)

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

• Check the expiry date (EXP) on the carton. Do not use if the expiry date on the carton has passed.
• Check to make sure the seal on the Adtralza carton is intact. Do not use the Adtralza pre-filled syringes if the seal on the carton is broken.

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

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

Place the Adtralza carton on the flat surface and wait 30 minutes before you inject Adtralza to let the pre-filled syringes reach room temperature (20 ºC to 30 ºC). This will help to make injection of Adtralza more comfortable.

• Do not heat the pre-filled syringes in any way.
• Do not shake the syringes.
• Do not remove the needle cover on the pre-filled syringes until you have reached Step 3 and are ready to inject.
• Do not put the syringes back in the refrigerator once they have reached room temperature.

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

Remove the 2 Adtralza pre-filled syringes one by one from the carton by grasping the body (not the plunger rod) of the Adtralza pre-filled syringes.

• Do not touch the needle guard clips to keep from activating the needle guard too soon.
• Do not remove the needle cover on the pre-filled syringes until you have reached Step 3 and are ready to inject.

1e: Inspect the 2 Adtralza pre-filled syringes

• Make sure the labels show the correct name of the medicine, Adtralza.
• Check the expiry date on the syringes.
• Check the medicine through the viewing windows. The medicine should be clear to opalescent, colourless to pale yellow.
• Do not use the Adtralza pre-filled syringes if:
  • the expiry date on the syringes has passed
  • the medicine is cloudy, discoloured, or has particles in it
  • the pre-filled syringes look damaged or have been dropped

If you cannot use the syringes, dispose of them in a puncture-resistant 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.

2a: Choose the area for your injections

• You may inject into:
  • your stomach area (abdomen)
  • your thighs
  • your upper arm. To inject into your upper arm, you will need a caregiver to give you the injections.
• Do not inject where the skin is tender, bruised, scaly, scarred, damaged, hard or covered with eczema.
• Do not inject within 5 cm of your belly button (navel).

2b: Wash your hands and prepare your skin

• Wash your hands with soap and water.
• Clean the injection area for the 2 injections with an alcohol swab using a circular motion.
  • Let the area dry completely.
  • Do not blow on or touch the cleaned area before injecting.

3a: Pull off the Adtralza needle cover

Hold the Adtralza pre-filled syringe body with one hand, pull the needle cover straight off with your other hand and throw it into the puncture-resistant container.

• Do not try to recap the Adtralza pre-filled syringes.
• Do not hold the plunger rod or plunger head while removing the needle cover.
• You may see a drop of liquid at the end of the needle. This is normal.
• Do not touch the needle, or let it touch any surface.

3b: Insert the needle

With one hand, gently pinch and hold a fold of skin where you cleaned the injection area. With the other hand, insert the needle completely into your skin at a 45-90 degree angle.

3c: Inject the medicine

Use your thumb to firmly push the plunger head all the way down. All the medicine is injected when you cannot push the plunger head any further.

3d: Release and remove

Lift your thumb off the plunger head. The needle will automatically move back inside the syringe body and lock into place.

• Place a dry cotton ball or gauze pad over the injection area for a few seconds. Do not rub the injection area. If needed, cover the injection area with a small bandage.
• There may be a small amount of blood or liquid where you injected. This is normal.

Throw away the used Adtralza pre-filled syringe in a puncture-resistant container. See Step 5 “Disposing of Adtralza”.

To get your full prescribed dose, you will need to give a second injection. Get a new Adtralza pre-filled syringe and repeat Steps 3 and 5.

Note

Make sure you give your second injection in the same body area, but at least 3 cm away from the first one.

• Put the used Adtralza pre-filled syringes in a puncture-resistant container straight away after use.
  • Do not throw the Adtralza pre-filled syringes in your household trash.
• If you do not have a puncture-resistant container, you may use a household container that is:
  • made of heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labelled to warn of hazardous waste inside the container.
• When your puncture-resistant container is almost full, you will need to follow your community guidelines for the right way to dispose of your puncture-resistant container.
• Do not recycle your used puncture-resistant container.