TALTZ 80 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the Patient

Taltz 80mg 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.

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
• Non-radiographic axial spondyloarthritis 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.

The use of 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 the 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 considers important (e.g. active tuberculosis).

Warnings and precautions

Consult your doctor before starting to use Taltz:

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

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

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

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

Monitor for infections and allergic reactions

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

Interrupt treatment with Taltz and inform your doctor or seek medical attention immediately if you notice any sign of serious infection or allergic reaction. These signs are included in section 4 "Serious side effects).

Children and adolescents

Do not use this medicine to treat plaque psoriasis in children under 6 years of age because it has not been studied in this age group.

Do not use this medicine to treat 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

Inform your doctor, pharmacist, or nurse:

• if you are using, have recently used, or might use any other medicine.
• 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 plan to become pregnant, consult your doctor before using 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 or plan to breastfeed, consult your doctor before using this medicine. You and your doctor must decide whether you can breastfeed or use Taltz. You must not do both at the same time.

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; i.e. it is essentially "sodium-free).

3. How to use Taltz

Follow exactly the instructions for administration of this medicine given by your doctor or nurse. If you are unsure, consult your doctor, nurse, or pharmacist again.

Taltz is administered 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.

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

Use a reminder method such as notes on a calendar or diary to help you remember when your next dose is due and avoid forgetting or taking extra 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 syringe contains a dose of Taltz (80 mg). Each syringe provides only one dose. The syringe should not be shaken.

Read carefully the "Instructions for use" of the syringe 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 syringes of 80 mg each) by subcutaneous injection. This dose may be administered by your doctor or nurse.
• After the first dose, you will use a dose of 80 mg (1 syringe) at week 2, 4, 6, 8, 10, and 12. From week 12 onwards, you will use a dose of 80 mg (1 syringe) 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:

Preparation of40mgofixekizumabinchildren

Doses of ixekizumab 40 mg should be prepared and administered by a qualified healthcare professional.

It is not recommended to use Taltz 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 syringes of 80 mg each) by subcutaneous injection. This dose may be administered by your doctor or nurse.
• After the first dose, you will use a dose of 80 mg (1 syringe) at week 2, 4, 6, 8, 10, and 12. From week 12 onwards, you will use a dose of 80 mg (1 syringe) every 4 weeks.

For other patients with psoriatic arthritis

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

Axial Spondyloarthritis

The recommended dose is 160 mg (2 syringes of 80 mg each) by subcutaneous injection at week 0, followed by 80 mg (1 syringe) 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 administered before it was indicated, inform your doctor.

If you forget to use Taltz

If you have forgotten to inject 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 psoriasis or psoriatic arthritis may return.

If you have any other questions about 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

Interrupt treatment with Taltz and consult 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:

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

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

Severe allergic reaction(may affect up to 1 in 1000 people) – the 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 accompanied by a rash or hives

Other reported side effects:

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

• upper respiratory tract infections with symptoms such as sore throat and nasal congestion.
• reactions at the injection site (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 (simple herpes, mucocutaneous).

Uncommon(may affect up to 1 in 100 people)

• white patches in the mouth (oral candidiasis).
• flu.
• nasal congestion.
• bacterial skin infection.
• hives.
• teary, itchy, red, and swollen eyes (conjunctivitis).
• signs of low white blood cell count in the blood, 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 stool (signs of intestinal 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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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 syringe and on the carton after EXP. The expiry date is the last day of the month shown.

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 outside 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 syringe is damaged or the medicine appears cloudy, is clearly brown, or contains particles.

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 packaging 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 syringe contains 80 mg of ixekizumab in 1 ml of solution.

• The other components are sucrose, polysorbate 80, 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 transparent glass syringe. Its color may vary from transparent to slightly yellow.

Packages of 1, 2, 3 pre-filled syringes. 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 medication 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 medicinal product 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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The following information is intended for healthcare professionals only:

Preparation of 40 mg of ixekizumab for children weighing 25 to 50 kg

The 40 mg doses of ixekizumab should be prepared and administered by a qualified healthcare professional. Use only the Taltz 80 mg solution for injection pre-filled syringe when preparing the prescribed pediatric doses of 40 mg.

1. Expel all the contents of the pre-filled syringe into a sterile and transparent glass vial. DO NOT shake or turn the vial.
2. Use a 0.5 ml or 1 ml disposable syringe and a sterile needle to withdraw the prescribed dose (0.5 ml for 40 mg) from the vial.
3. Change the needle and use a sterile 27-gauge needle to inject the patient. Discard any unused ixekizumab remaining in the vial.

The preparation of ixekizumab should be administered within 4 hours of puncturing the sterile vial at room temperature.