Prescribing Information for the Patient

Taltz 80 mg pre-filled syringe solution for injection

ixekizumab

Read this entire prescribing information carefully before starting to use this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prescribing information. See section 4.

Taltz contains the active ingredient ixekizumab.

Taltz is used for the treatment of the following inflammatory diseases:

• Plaque psoriasis in adults
• Plaque psoriasis in children aged 6 years and older 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 for the treatment of a skin disorder known as "plaque psoriasis" in adults and in children aged 6 years and older 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 produces improvements in the appearance of skin lesions and a decrease in symptoms such as scaling, itching, and pain.

Psiatic Arthritis

Taltz is used for the treatment of a disorder known as "psoriatic arthritis" in adults, an inflammatory joint disease, often accompanied by psoriasis. If you have psoriatic arthritis, you will first receive other medicines. If you do not respond sufficiently well or do not tolerate these medicines, you will receive Taltz to reduce the 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 daily normal 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 spine joints, 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 be given other medicines. If you do not respond sufficiently well to these medicines, you will be given Taltz to reduce the signs and symptoms of the disease, decrease inflammation, and improve your physical function.

Do not use Taltz

• If you are allergic to ixekizumab or any of the other components of this medication (listed in section6). If you think you may be allergic, consult your doctor before using Taltz.
• If you have any infection that your doctor considers important (for example, 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 diseasethat affects the intestinecalled Crohn's disease.
• If you have aninflammationof 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.

Intestinal inflammatory 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 the stool (any sign of intestinal problems).

If you are unsure if you are in any of the above situations, consult your doctor or nurse before using Taltz.

Watch for the appearance of infections and allergic reactions

Taltz may potentially cause severe side effects, including infections and allergic reactions. You must watch for the 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 severe infection or an allergic reaction. These signs are listed in section4 “Severe side effects”.

Children and adolescents

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

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

Other medications and Taltz

Inform your doctor, pharmacist, or nurse:

• If you are using, have used recently, or may need to use any other medication.
• If you have been vaccinated recently or are going to be vaccinated. You should not receive some 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 medication. It is preferable to avoid using Taltz during pregnancy. The effects of this medication on pregnant women are unknown. If you are a fertile woman, it is recommended that you avoid becoming pregnant and use an appropriate contraceptive while using Taltz and for at least 10weeks after the last dose of Taltz.

If you are breastfeeding or plan to breastfeed, consult your doctor before using this medication. You and your doctor must decide if you can breastfeed or use Taltz. You should not do both at the same time.

Driving and operating machines

It is unlikely that Taltz will affect your ability to drive or operate machines.

Taltz contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or nurse. If in doubt, consult your doctor, nurse, or pharmacist again.

Taltz is administered by subcutaneous injection. You and your doctor or nurse should decide whether you should inject Taltz yourself.

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

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

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

Use a reminder method such as notes in a calendar or agenda to help you remember when you have your next dose and avoid missed or repeated doses.

Taltz is a long-term treatment. Your doctor or nurse will monitor your disease state periodically to check if the treatment is effective.

Each pen contains a 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 should be administered and for how long

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

Psoriasis in adults

• The first dose is 160 mg (2 pens 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 pen) every week at weeks 2, 4, 6, 8, 10, and 12. From week 12 onwards, you will use a dose of 80 mg (1 pen) every 4 weeks.

Psoriasis in children (6 years or older and a minimum of 25 kg body weight) and adolescents

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

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

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

It is not recommended to use Taltz in children with a body weight less than 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 administered by your doctor or nurse.
• After the first dose, you will use a dose of 80 mg (1 pen) every week at weeks 2, 4, 6, 8, 10, and 12. From week 12 onwards, you will use a dose of 80 mg (1 pen) every 4 weeks.

For the rest of patients with psoriatic arthritis

• The first dose is 160 mg (2 pens 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 pen) every 4 weeks.

Ankylosing spondylitis

The recommended dose is 160 mg (2 pens of 80 mg each) by subcutaneous injection in 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 administered before the indicated time, inform your doctor.

If you forget to use Taltz

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

If you interrupt treatment with Taltz

You should not interrupt the use of Taltz without speaking with your doctor first. If you stop treatment, the symptoms of psoriasis or psoriatic arthritis may reappear.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Stop treatment with Taltz and consult your doctor or seek immediate medical assistance if you notice any of the following side effects. Your doctor will decide whether you should and when you can resume treatment:

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

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

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

• difficulty breathing or swallowing
• low blood pressure, which may cause dizziness or lightheadedness
• swelling of the face, lips, tongue, or throat
• intense itching of the skin accompanied by rash or hives

Other reported side effects:

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

• 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 1in 10people)

• nausea.
• fungal infections such as athlete's foot.
• posterior throat pain.
• mouth ulcers, on the skin, and on mucous membranes (herpes simplex, mucocutaneous).

Uncommon(may affect up to 1in 100people)

• white patches in the mouth (oral candidiasis).
• influenza.
• nasal congestion.
• skin bacterial infection.
• urticaria.
• eyes with tearing, itching, redness, and swelling (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 inflammation 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 1000people)

• esophageal fungal infection (esophageal candidiasis)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the pen label and on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

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

Do not use this medication if you observe that the pen is deteriorated or the medication appears cloudy, is clearly brown in color, or has particles inside.

This medication is for single use only.

Medications should not be disposed of through drains. Ask your doctor, pharmacist, or nurse how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Taltz

• The active ingredient is ixekizumab.

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

• The other components are sucrose, polisorbate 80, water for injection. Additionally, sodium hydroxide may have been added to adjust the pH.

Appearance of the product and contents of the pack

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

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

Packs 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.

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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