Taltz 80 mg solution for injection in pre-filled pen

• 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 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

• 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).

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.

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.

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.

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.

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 adequate 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.

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

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

Your doctor will explain to you how much Taltz you need and for how long.

Plaque psoriasis in adults

• The first dose is 160 mg (2 pens with 80 mg each) by subcutaneous injection. This may be given by your doctor or nurse.
• After the first dose, you will use an 80 mg dose (1 pen) at weeks 2, 4, 6, 8, 10, and 12. From week 12, you will use an 80 mg dose (1 pen) every 4 weeks.

Plaque psoriasis in children (age 6 years and above and at least 25 kg body weight) and in adolescents.

The recommended dose given by subcutaneous injection in children is based on the following weight categories:

Children’s body weight: Greater than 50 kg

Recommended starting dose (week 0): 160 mg (2 pens)

Recommended dose every 4 weeks (Q4W) thereafter: 80 mg (1 pen)

Children’s body weight: 25 to 50 kg

Recommended starting dose (week 0): 80 mg (1 pen)

Recommended dose every 4 weeks (Q4W) thereafter: 40 mg (dose preparation required)

Ixekizumab doses of 40 mg must be prepared and administered by a qualified healthcare professional using the commercial Taltz 80 mg/1 ml pre-filled syringe.

Use the Taltz 80 mg pre-filled pen only in those children that require a dose of 80 mg. Do not use the Taltz 80 mg pre-filled pen for the preparation of the 40 mg dose.

Taltz is not recommended for use in children with a body weight below 25 kg.

Psoriatic arthritis

For psoriatic arthritis patients who also have moderate to severe plaque psoriasis:

• The first dose is 160 mg (2 pens with 80 mg each) by subcutaneous injection. This may be given by your doctor or nurse.
• After the first dose, you will use an 80 mg dose (1 pen) at weeks 2, 4, 6, 8, 10, and 12. From week 12, you will use an 80 mg dose (1 pen) every 4 weeks.

For other psoriatic arthritis patients

• The first dose is 160 mg (2 pens with 80 mg each) by subcutaneous injection. This may be given by your doctor or nurse.
• After the first dose you will use an 80 mg dose (1 pen) every 4 weeks.

Axial spondyloarthritis

The recommended dose is 160 mg (2 pens with 80 mg each) by subcutaneous injection at week 0, followed by 80 mg (1 pen) every 4 weeks.

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

If you have forgotten to inject a dose of Taltz, talk to your doctor.

You should not stop using Taltz without speaking to your doctor first. If you stop treatment, symptoms of psoriasis or psoriatic arthritis may come back.

Stop using Taltz and tell your doctor or seek medical help immediately if you get any of the following side effects. Your doctor will decide if and when you may restart the treatment:

Possible serious infection (may affect up to 1 in 100 people) - the signs may include:

• fever, flu-like symptoms, night sweats
• feeling tired or short of breath, cough which will not go away
• warm, red and painful skin, or a painful skin rash with blisters

Serious allergic reaction (may affect up to 1 in 1,000 people) - the signs may include:

• difficulty breathing or swallowing
• low blood pressure, which can cause dizziness or light-headedness
• swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised bumps

Very common (may affect more than 1 in 10 people)

• upper respiratory tract infections with symptoms such as sore throat and stuffy nose.
• injection site reactions (e.g. red skin, pain).

Common (may affect up to 1 in 10 people)

• nausea.
• fungal infections such as athlete’s foot.
• pain in the back of the throat.
• cold sores of mouth, skin and mucous membranes (herpes simplex, mucocutaneous)

Uncommon (may affect up to 1 in 100 people)

• oral thrush (oral candidiasis).
• influenza.
• runny nose.
• bacterial skin infection.
• hives.
• discharge from the eye with itching, redness and swelling (conjunctivitis).
• signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections (neutropenia).
• low blood platelet count (thrombocytopenia).
• eczema
• rash
• rapid swelling of the tissues of the neck, face, mouth or throat (angioedema)
• abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems).

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

• fungal infection of the oesophagus (oesophageal candidiasis)

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, website: 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 ixekizumab.
  Each pre-filled pen contains 80 mg of ixekizumab in 1 ml solution.
• The other ingredients are sucrose; polysorbate 80; water for injections. In addition, sodium hydroxide may have been added for pH adjustment.

Taltz is a solution in a clear glass syringe. Its colour may vary from colourless to slightly yellow.

The syringe is encased in a disposable, single-dose pen.

Pack sizes of 1, 2, 3 pre-filled pens. Not all pack sizes may be available in your country.

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