Taltz 80 mg solution for injection in pre-filled syringe

XPIL (Text-only Patient Information Leaflet)

Source: Taltz_PIL_TA054_Jun25_IE_MT.pdf

Note: This XPIL text version is intended for accessibility (screen readers / large print).

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Package leaflet: Information for the patient

Taltz® 80 mg solution for injection in pre-filled syringe

ixekizumab

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.

What is in this leaflet

1. What Taltz is and what it is used for

2. What you need to know before you use Taltz

3. How to use Taltz

4. Possible side effects

5. How to store Taltz

6. Contents of the pack and other information

1. What Taltz is and what it is used for

Taltz contains the active substance ixekizumab.

Taltz is intended for the treatment of the inflammatory diseases described below:

- Plaque psoriasis in adults

- Plaque psoriasis in children from the age of 6 and with a body weight of at least 25 kg and in adolescents

- Psoriatic arthritis in adults

- Radiographic axial spondyloarthritis in adults

- Non-radiographic axial spondyloarthritis in adults

Ixekizumab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by blocking the activity of a protein called IL-17A, which promotes psoriasis and inflammatory disease of the joints and the spine.

Plaque psoriasis

Taltz is used to treat a skin condition called “plaque psoriasis” in adults and in children from the age of 6 years and with a body weight of at least 25 kg and in adolescents with moderate to severe disease. Taltz reduces the signs and symptoms of the disease.

Using Taltz will benefit you by improvements of skin clearance and reducing your symptoms such as scaling, itching and pain.

Psoriatic arthritis

Taltz is used to treat a condition called “psoriatic arthritis” in adults, an inflammatory disease of the joints, often accompanied by psoriasis. If you have psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines or in case of intolerance, you will be given Taltz to reduce the signs and symptoms of the disease. Taltz can be used alone or with another medicine named methotrexate.

Using Taltz will benefit you by reducing the signs and symptoms of the disease, improving physical function (ability to do normal daily activities), and slowing down the damage to the joints.

Axial spondyloarthritis

Taltz is used to treat adults with an inflammatory disease primarily affecting the spine which causes inflammation of the spinal joints, called axial spondyloarthritis. If the condition is visible using X-rays, it is referred to as “radiographic axial spondyloarthritis”; if it occurs in patients with no visible signs on X-rays, it is referred to as “non-radiographic axial spondyloarthritis”. If you have axial spondyloarthritis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Taltz to reduce the signs and symptoms of the disease, reduce inflammation and improve your physical function.

2. What you need to know before you use Taltz

Do not use Taltz

- if you are allergic to ixekizumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice before using Taltz.

- if you have an infection which your doctor thinks is important (for example, active tuberculosis).

Warnings and precautions

Talk to your doctor before using Taltz:

- if you currently have an infection or if you have long-term or repeated infections.

- if you have an inflammatory disease affecting the gut named Crohn’s disease.

- if you have an inflammation of the large intestine named ulcerative colitis.

- if you are receiving any other treatment for psoriasis (such as immunosuppressant or phototherapy with ultraviolet light) or for psoriatic arthritis.

Inflammatory bowel disease (Crohn's disease or ulcerative colitis)

Stop using Taltz and tell your doctor or seek medical help immediately if you notice abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (any signs of bowel problems).

If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Taltz.

Look out for infections and allergic reactions

Taltz can potentially cause serious side effects, including infections and allergic reactions. You must look out for signs of these conditions while you are using Taltz.

Stop using Taltz and tell your doctor or seek medical help immediately if you notice any signs of a serious infection or an allergic reaction. Such signs are listed under “Serious side effects” in section 4.

Children and adolescents

- Do not use this medicine for the treatment of plaque psoriasis in children under 6 years of age because it has not been studied in this age group.

- Do not use this medicine for the treatment of psoriatic arthritis in children and adolescents under 18 years of age because it has not been studied in this age group.

Other medicines and Taltz

Tell your doctor, pharmacist or nurse:

- if you are using, have recently used or might use any other medicines.

- if you have recently had or are due to have a vaccination. You should not be given certain types of vaccines while using Taltz.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

It is preferable to avoid the use of Taltz in pregnancy. The effects of this medicine in pregnant women are not known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use effective contraception while using Taltz and for at least 10 weeks after the last Taltz dose.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. You and your doctor should decide if you can breast-feed or use Taltz. You should not do both.

Driving and using machines

Taltz is unlikely to influence your ability to drive and use machines.

Taltz contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 80 mg dose, that is to say essentially “sodium-free”.

Taltz contains polysorbate

This medicine contains 0.30 mg of polysorbate 80 in each 80 mg pre-filled syringe, which is equivalent to 0.30 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How to use Taltz

Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much Taltz is given

- Your doctor will decide how much Taltz you need and for how long.

- Each injection contains 80 mg ixekizumab.

- The recommended dose is different depending on the disease being treated, your age, and your body weight (in children).

- Refer to the package leaflet instructions given by your doctor or nurse for your specific condition.

Method and route of administration

- Taltz is given as an injection under the skin (subcutaneous injection).

- You and your doctor or nurse should decide if you can inject Taltz yourself.

- Always use Taltz exactly as your doctor or nurse has told you.

- Do not shake the pre-filled syringe.

- Instructions for use are included at the end of the leaflet (in the full product pack).

- If you inject yourself, read and follow the “Instructions for Use” carefully.

If you use more Taltz than you should

- If you have received more Taltz than you should or the dose has been given sooner than prescribed, tell your doctor immediately.

If you forget to use Taltz

- If you miss an injection, inject the next dose as soon as you remember. Then talk to your doctor to discuss when you should inject the next dose.

- Do not take a double dose to make up for a forgotten dose.

If you stop using Taltz

- Do not stop using Taltz without talking to your doctor first. If you stop treatment, your symptoms may come back.

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.

Serious side effects

Tell your doctor or seek medical help immediately if you notice any of the following:

- Serious allergic reactions (may affect up to 1 in 1,000 people): difficulty breathing, swelling of the face, lips, mouth or throat, severe itching, rash or hives.

- Serious infections (frequency not known): high fever, flu-like symptoms, night sweats, feeling tired or short of breath, cough, persistent weight loss, diarrhoea, abdominal pain, blood in stools.

Other side effects

Common (may affect up to 1 in 10 people):

- upper respiratory tract infections with symptoms such as sore throat and stuffy nose

- nausea

- injection site reactions (such as redness, pain)

Uncommon (may affect up to 1 in 100 people):

- oral thrush (white patches in the mouth)

- athlete’s foot (skin peeling between the toes)

- stye (painful swelling on eyelid)

- hives

- influenza (flu)

Rare (may affect up to 1 in 1,000 people):

- serious allergic reactions

Not known (frequency cannot be estimated from available data):

- inflammatory bowel disease (Crohn’s disease or ulcerative colitis)

Reporting of side effects

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:

Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie  

Malta: ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal  

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

5. How to store Taltz

- 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 carton and syringe label after “EXP”. The expiry date refers to the last day of that month.

- Store in a refrigerator (2°C–8°C). Do not freeze.

- Keep the pre-filled syringe in the outer carton in order to protect from light.

- Do not shake.

- If necessary, Taltz can be kept at room temperature (up to 30°C) for up to 5 days. After this time, the syringe must not be returned to the refrigerator and must be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Taltz contains

- The active substance is ixekizumab. Each pre-filled syringe contains 80 mg of ixekizumab in 1 ml solution.

- The other ingredients are sodium chloride, polysorbate 80, citric acid monohydrate, sodium citrate, and water for injections.

What Taltz looks like and contents of the pack

- Taltz is a clear to slightly opalescent and colourless to slightly yellow solution.

- It is supplied in a pre-filled syringe containing 1 ml solution.

- The pack contains either 1 or 2 pre-filled syringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Manufacturer

Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019 Sesto Fiorentino, Florence, Italy

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

Ireland

Eli Lilly and Company (Ireland) Limited  

Tel: +353-(0)1 661 4377  

Malta

Charles de Giorgio Ltd.  

Tel: +356 25600 500  

This leaflet was last revised in June 2025.  

TA054  

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