Taltz 80 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Taltz 80 mg solution for injection in pre-filled pen

ixekizumab

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Taltz is and what it is used for
2. What you need to know before using 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 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
• Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis in patients from 6 years of age or older and with a body weight of at least 25 kg

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 diseases of the joints and spine.

Plaque psoriasis

Taltz is used to treat a skin disorder known as "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.

Taking Taltz will benefit you by improving the appearance of skin lesions and reducing symptoms such as scaling, itching, and pain.

Psoriatic arthritis

Taltz is used to treat a disorder known as "psoriatic arthritis" in adults, an inflammatory joint disease often accompanied by psoriasis. If you have psoriatic arthritis, you will first be given other medications. If you do not respond adequately or cannot tolerate these medications, you will be given Taltz to reduce the signs and symptoms of the disease. Taltz can be used alone or in combination with another medicine called methotrexate.

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

Axial spondyloarthritis

Taltz is used to treat adults with an inflammatory disease that primarily affects the spine and causes inflammation of the spinal 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 treated with other medications. If you do not respond adequately to these treatments, Taltz will be administered to reduce the signs and symptoms of the disease, decrease inflammation, and improve your physical function.

Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis

Taltz is used in patients from 6 years of age or older and with a body weight of at least 25 kg to treat juvenile idiopathic arthritis conditions known as "juvenile psoriatic arthritis" and "enthesitis-related arthritis". These diseases are inflammatory conditions affecting the joints and the sites where tendons attach to bone.

Using Taltz will benefit you by reducing disease symptoms and improving physical function.

2. What you need to know before using Taltz

Do not use Taltz

• if you are allergic to ixekizumab or to 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 an infection that your doctor considers serious (for example, active tuberculosis).

Warnings and precautions

Talk to your doctor before starting Taltz:

• if you currently have an infection or suffer from repeated or prolonged infections.
• if you have an inflammatory bowel disease 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 phototherapy) or for psoriatic arthritis.

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

Stop using Taltz and inform your doctor or seek immediate medical attention if you experience abdominal cramps and pain, diarrhoea, weight loss, or blood in your stools (any signs of intestinal problems).

If you are unsure whether any of the above apply to you, consult your doctor or nurse before using Taltz.

Monitor for infections and allergic reactions

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

Stop treatment with Taltz and contact your doctor or seek immediate medical assistance if you notice any signs of a serious infection or an allergic reaction. These signs are listed in section 4, “Serious adverse effects”.

Children and adolescents

Do not use this medicine for the treatment of plaque psoriasis or juvenile idiopathic arthritis (juvenile psoriatic arthritis and enthesitis-related arthritis) in children under 6 years of age and weighing less than 25 kg, as it has not been studied in this age group.

Other medicines and Taltz

Inform your doctor, pharmacist, or nurse:

• if you are taking, have recently taken, or might need to take any other medicines.
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines should not be administered while you are 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 preferable to avoid using Taltz during pregnancy. The effects of this medicine in pregnant women are unknown. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and should use an effective method of 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 will breastfeed or use Taltz. You should not do both at the same time.

Driving and using machines

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

Taltz contains sodium

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

Taltz contains polysorbate

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

3. How to use Taltz

Follow exactly the administration instructions for 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 whether you should self-inject Taltz.

For use in children with a body weight of 25–50 kg, if the 40 mg pre-filled syringe is not available, the 40 mg dose of ixekizumab must be prepared and administered by a qualified healthcare professional.

It is important that you do not attempt to inject the medicine yourself until you have been trained in how to do so by your doctor or nurse. A caregiver may also 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, thus avoiding missed or repeated doses.

Taltz is a long-term treatment. Your doctor or nurse will periodically monitor your condition to check whether the treatment is having the desired effect.

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

Read carefully the "Instructions for Use" leaflet 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 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 at week 2, 4, 6, 8, 10, and 12. From week 12 onwards, you will use a dose of 80 mg every 4 weeks.

Plaque psoriasis in patients 6 years of age or older and weighing at least 25 kg.

Juvenile idiopathic arthritis in patients 6 years of age or older and weighing at least 25 kg.

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

Preparation of 40 mg of ixekizumab in children

If the 40 mg pre-filled syringe is not available, ixekizumab doses of 40 mg must be prepared and administered by a qualified healthcare professional.

The use of Taltz is not recommended in children weighing 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 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 at week 2, 4, 6, 8, 10, and 12. From week 12 onwards, you will use a dose of 80 mg every 4 weeks.

For all other patients with psoriatic arthritis:

• The first dose is 160 mg 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 every 4 weeks.

Axial spondyloarthritis

The recommended dose is 160 mg by subcutaneous injection in week 0, followed by 80 mg every 4 weeks.

If you use more Taltz than you should

If you have received more Taltz than you should, or if the dose was administered earlier than instructed, 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 stop using Taltz

You must not stop using Taltz without first talking to your doctor. If you discontinue treatment, symptoms of psoriasis or psoriatic arthritis may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

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

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

• fever, flu-like symptoms, night sweats
• feeling tired or short of breath, persistent cough
• painful, red, or warm skin, or painful skin rash with blisters

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

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

Other reported adverse effects:

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., redness, 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, skin, and mucous membrane ulcers (herpes simplex, mucocutaneous)

Uncommon (may affect up to 1 in 100 people)

• white lesions in the mouth (oral candidiasis)
• influenza
• nasal congestion
• bacterial skin infection
• hives
• watery, 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
• painful, itchy, fluid-filled blisters (dyshidrosis)
• rash
• rapid swelling of tissues in 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 1,000 people)

• fungal infection of the esophagus (esophageal candidiasis)
• skin redness and peeling (exfoliative dermatitis)

Other adverse effects in children and adolescents

Common (may affect up to 1 in 10 people)

• influenza
• nasal congestion
• hives
• watery, itchy, red, and swollen eyes (conjunctivitis)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the syringe label and packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Keep in the original packaging to protect from light.

Taltz may be kept outside the refrigerator for up to 5 days at a temperature not exceeding 30 °C.

Do not use this medicine if you notice that the syringe is damaged or if the medicine appears cloudy, clearly brown in colour, or contains particles.

This medicine is for single use only.

Medicines should not be disposed of via wastewater. Ask your doctor, pharmacist, or nurse how to dispose of any medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Taltz

• The active substance 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 injections. Sodium hydroxide may also have been added to adjust the pH (see section 2 “Taltz contains sodium” and “Taltz contains polysorbate”).

Nature of the product and contents of the pack

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

Pack sizes of 1, 2, or 3 pre-filled syringes. Only certain pack sizes may be marketed.

Marketing Authorisation 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.

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

The following information is intended for healthcare professionals only:

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

If the 40 mg pre-filled syringe is not available, doses of ixekizumab 40 mg must be prepared and administered by a qualified healthcare professional. Use only the Taltz 80 mg pre-filled syringe for injection when preparing the prescribed pediatric doses of 40 mg.

1. Expel the entire content of the pre-filled syringe into a sterile, transparent glass vial. DO NOT shake or rotate the vial.
2. Use a disposable 0.5 ml or 1 ml 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 into the patient. Discard any unused ixekizumab remaining in the vial.

The prepared ixekizumab solution must be administered within 4 hours after puncturing the sterile vial, at room temperature.