TALTZ 80 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Introduction

Package Leaflet: Information for the Patient

Taltz 80mg solution for injection in pre-filled pen

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 experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Taltz and what is it used for

Taltz contains the active substance ixekizumab.

Taltz is used to treat the following inflammatory diseases:

• Plaque psoriasis in adults
• Plaque psoriasis in children from 6 years of age and with a body weight of at least 25 kg and in adolescents
• Psoriatic arthritis in adults
• Ankylosing spondylitis in adults
• Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults

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

Plaque Psoriasis

Taltz is used to treat a skin condition called plaque psoriasis in adults and in children from 6 years of age 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 because it improves the appearance of skin lesions and reduces 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 receive other medicines. If you do not respond well enough or do not tolerate these medicines, you will receive Taltz to reduce signs and symptoms of the disease. Taltz can be used alone or with another medicine called methotrexate.

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

Axial Spondyloarthritis

Taltz is used to treat adults with an inflammatory disease that mainly affects the spine and causes inflammation of the joints of the spine, called axial spondyloarthritis. If the condition is visible on X-rays, it is called ankylosing spondylitis or radiographic axial spondyloarthritis; if it occurs in patients without visible signs on X-rays, it is called non-radiographic axial spondyloarthritis. If you have axial spondyloarthritis, you will first receive other medicines. If you do not respond well enough to these medicines, you will receive Taltz to reduce signs and symptoms of the disease, decrease 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, consult your doctor before using Taltz.
• if you have any infection that your doctor thinks is important (for example, active tuberculosis).

Warnings and precautions

Talk to your doctor before starting Taltz:

• if you currently have an infection or if you get repeated or prolonged infections.
• if you have a gut condition called Crohn's disease.
• if you have inflammation of the large intestine called ulcerative colitis.
• if you are receiving any other treatment for psoriasis (such as immunosuppressants or ultraviolet light therapy) or for psoriatic arthritis.

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

Stop using Taltz and tell your doctor or seek medical attention immediately if you notice abdominal cramps and pain, diarrhea, weight loss, or blood in your stools (any sign of bowel problems).

If you are not sure if you are in any of the above situations, consult your doctor or nurse before using Taltz.

Watch for signs of infections and allergic reactions

Taltz may potentially cause serious side effects, including infections and allergic reactions. You should watch for signs of these conditions while using Taltz.

Stop treatment with Taltz and tell your doctor or seek medical attention immediately if you notice any signs of serious infection or an allergic reaction. These signs are listed in section 4 “Serious side effects”.

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 been vaccinated recently or are going to be vaccinated. You should not receive certain types of vaccines while using Taltz.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. It is recommended that you avoid using Taltz during pregnancy. The effects of this medicine in pregnant women are not known. If you are a woman of childbearing age, you are advised to avoid becoming pregnant and must use adequate contraception while using Taltz and for at least 10 weeks after the last dose of Taltz.

If you are breastfeeding, ask your doctor for advice before taking this medicine. You and your doctor will decide whether you can breastfeed or use Taltz. You should not do both.

Driving and using machines

Taltz is unlikely to affect your ability to drive or use machines.

Taltz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 80 mg dose; this is essentially “sodium-free”.

3. How to use Taltz

Follow the instructions for administration of this medicine exactly as told by your doctor or nurse. If you are not sure, consult your doctor, nurse, or pharmacist again.

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

For use in children with a body weight of 25-50 kg, the dose of 40 mg of ixekizumab should be prepared and administered by a qualified healthcare professional.

Use the Taltz 80 mg pre-filled pen only in those children who require a dose of 80 mg and do not require dose preparation.

It is important that you do not try to inject the medicine until you have been trained on how to do it by your doctor or nurse. A caregiver can also give you your Taltz injection if they have been properly trained.

Use a reminder method such as notes on a calendar or a planner to help you remember when your next dose is due and avoid missing or duplicating doses.

Taltz is a long-term treatment. Your doctor or nurse will periodically check the status of your disease to see if the treatment is having the desired effect.

Each pen contains one dose of Taltz (80 mg). Each pen provides only one dose. The pen should not be shaken.

Read the “Instructions for use” of the pen carefully before using Taltz.

How much Taltz to use and for how long

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

Plaque psoriasis in adults

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

Plaque psoriasis in children (6 years of age or older and a minimum body weight of 25 kg) and in adolescents.

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

Doses of 40 mg of ixekizumab should be prepared and administered by a qualified healthcare professional using the Taltz 80 mg/1 ml pre-filled syringes.

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

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

Psoriatic Arthritis

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

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

For other patients with psoriatic arthritis

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

Axial Spondyloarthritis

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

If you use more Taltz than you should

If you have received more Taltz than you should or the dose has been given before it was due, tell your doctor.

If you forget to use Taltz

If you have missed injecting a dose of Taltz, talk to your doctor.

If you stop using Taltz

Do not stop using Taltz without talking to your doctor first. If you stop treatment, the symptoms of your psoriasis or psoriatic arthritis may come back.

If you have any other 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

Stop treatment with Taltz and talk to your doctor or seek medical attention immediately if you notice any of the following side effects. Your doctor will decide if you should and when you can restart treatment:

Severe infection(may affect up to 1 in 100 people) – signs may include:

• fever, flu-like symptoms, night sweats
• feeling tired or having difficulty breathing, persistent cough
• painful, red, or hot skin, or skin rash with blisters

Severe allergic reaction(may affect up to 1 in 1000 people) – signs may include:

• difficulty breathing or swallowing
• low blood pressure, which can cause dizziness or fainting
• swelling of the face, lips, tongue, or throat
• intense itching of the skin with rash or hives

Other side effects reported:

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

• upper respiratory tract infections with symptoms such as sore throat and nasal congestion.
• 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.
• mouth ulcers, skin, and mucous membrane ulcers (herpes simplex, mucocutaneous).

Uncommon(may affect up to 1 in 100 people)

• white patches in the mouth (oral candidiasis).
• flu.
• nasal congestion.
• bacterial skin infection.
• hives.
• watery, itchy, red, and swollen eyes (conjunctivitis).
• signs of low white blood cell count, such as fever, sore throat, or mouth ulcers due to infection (neutropenia).
• low platelet count in the blood (thrombocytopenia).
• eczema.
• rash.
• rapid swelling of the tissues of the neck, face, mouth, or throat (angioedema).
• abdominal cramps and pain, diarrhea, weight loss, or blood in the stools (signs of bowel problems).

Rare(may affect up to 1 in 1000 people)

• fungal infection of the esophagus (esophageal candidiasis)

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 label of the pen and on the carton after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (2°C to 8°C). Do not freeze. Do not push to the back of the fridge.

Store in the original package to protect from light.

Taltz can be left out of the refrigerator for up to 5 days at a temperature not above 30°C.

Do not use this medicine if you notice that the pen is damaged or the medicine appears cloudy, is clearly brown, or has particles in it.

This medicine is for single use only.

Medicines should not be disposed of via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to dispose of the pen and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Taltz Composition

• The active ingredient is ixekizumab.

Each pre-filled pen contains 80 mg of ixekizumab in 1 ml of solution.

• The other components are sucrose, polysorbate 80, and water for injectable preparations. Additionally, sodium hydroxide may have been added to adjust the pH.

Product Appearance and Container Contents

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

The syringe is inserted into a disposable pen for a single dose.

Packages of 1, 2, 3 pre-filled pens. Only some pack sizes may be marketed.

Marketing Authorization Holder

Eli Lilly and Company (Ireland) Limited, Dunderrow, Kinsale, Co. Cork, Ireland.

Manufacturer

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/, and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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