Taltz 80 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Taltz 80 mg solution for injection in a 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; 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; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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 adverse reactions
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 do not tolerate these medications, you will be given Taltz to reduce 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 signs and symptoms of the disease, improving physical function (ability to perform normal daily activities), and slowing 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-ray, it is called "ankylosing spondylitis or radiographic axial spondyloarthritis"; if it occurs in patients without visible signs on X-ray, it is called "non-radiographic axial spondyloarthritis". If you have axial spondyloarthritis, you will first be given other medications. If you do not respond adequately to these medications, you will be given Taltz to reduce signs and symptoms of the disease, reduce 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.

Taking Taltz will benefit you by reducing disease symptoms and improving your 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 components 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 significant (for example, active tuberculosis).

Warnings and precautions

Talk to your doctor before starting to use 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, diarrhea, weight loss, or blood in the stool (any sign of intestinal problems).

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

Watch 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 help 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 due 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. Women of childbearing potential are advised to avoid becoming pregnant and should use an effective contraceptive method 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 should 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; essentially "sodium-free".

Taltz contains polysorbate

This medicine contains 0.30 mg of polysorbate 80 in each 80 mg pre-filled pen, 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 instructions for administering this medicine as given by your doctor or nurse. If in doubt, 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, the 40 mg dose of ixekizumab must be prepared and administered by a qualified healthcare professional.

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

It is important that you do not attempt to inject the medicine 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 in an agenda to help you remember when your next dose is due, so as to avoid 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 pen contains one dose of Taltz (80 mg). Each pen provides only one dose. Do not shake the pen.

Carefully read the “Instructions for Use” of the pen 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.

Plaque 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) 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.

Plaque psoriasis in patients 6 years of age or older and with a minimum body weight of 25 kg.

Juvenile idiopathic arthritis in patients 6 years of age or older and with a minimum body weight of 25 kg.

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

If the 40 mg pre-filled syringe is not available, the 40 mg doses of ixekizumab must be prepared and administered by a qualified healthcare professional using the commercially available Taltz 80 mg pre-filled syringes.

Use the Taltz 80 mg pre-filled pen only for children who require an 80 mg dose. Do not use the Taltz 80 mg pre-filled pen for preparing the 40 mg dose.

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 (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) at week 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 all other 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.

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 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 should 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 help 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
• skin that is painful, red, or warm to the touch, 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 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 (oral herpes, mucocutaneous)

Uncommon (may affect up to 1 in 100 people)

• whitish 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 neck, face, mouth, or throat tissues (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)
• redness and peeling of the skin (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 listed 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 label of the pen and on the carton 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 place at 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 pen is damaged or if the medicine appears cloudy, clearly brownish 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 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 pen 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”).

Appearance 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.

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

Pack sizes of 1, 2, or 3 pre-filled pens. Not all 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.

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

Pen Components Guide