Package leaflet: Information for the patient

Taltz 40 mg solution for injection in pre-filled syringe

ixekizumab
Please 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 questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Taltz is and what it is used for
What you need to know before using Taltz
How to use Taltz
Possible side effects
How to store Taltz
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 indicated for the treatment of the following inflammatory diseases:

plaque psoriasis in adults
plaque psoriasis in children from 6 years of age and weighing at least 25 kg, and in adolescents
psoriatic arthritis in adults
radiographic axial spondyloarthritis in adults
non-radiographic axial spondyloarthritis in adults
juvenile idiopathic arthritis, including juvenile psoriatic arthritis and enthesitis-related arthritis, in patients aged 6 years and older weighing 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 contributes to the development of psoriasis and inflammatory diseases of the joints and spine.

Plaque psoriasis
Taltz is used to treat a skin condition called “plaque psoriasis” of moderate to severe degree in adults, children from 6 years of age and weighing at least 25 kg, and in adolescents. Taltz reduces the signs and symptoms of the disease.
The use of Taltz will benefit you by improving skin manifestations and reducing symptoms such as scaling, itching, and pain.

Psoriatic arthritis
Taltz is used in adults to treat a condition called “psoriatic arthritis”, an inflammatory joint disease often accompanied by psoriasis. If you have psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines or if you experience intolerance, Taltz will be prescribed to reduce the signs and symptoms of the disease. Taltz may be used alone or in combination with another medicine called methotrexate.
The use of Taltz will benefit you by reducing the signs and symptoms of the disease, improving physical function (ability to perform normal daily activities), and slowing joint damage.

Axial spondyloarthritis
Taltz is used in adults to treat an inflammatory disease primarily affecting the spine, causing inflammation of the spinal joints, called “axial spondyloarthritis”.
If the disease is visible on X-rays, it is defined as "radiographic axial spondyloarthritis"; if it occurs in patients without visible signs on X-rays, it is defined as "non-radiographic axial spondyloarthritis". If you have axial spondyloarthritis, you will first be treated with other medicines. If you do not respond adequately to these treatments, Taltz will be given to reduce the signs and symptoms of the disease, reduce inflammation, and improve physical function.

Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis
Taltz is used in patients aged 6 years and older weighing at least 25 kg for the treatment of conditions falling under the categories of juvenile idiopathic arthritis called “juvenile psoriatic arthritis” and “enthesitis-related arthritis”. These conditions are inflammatory diseases affecting the joints and the sites where tendons attach to bone.
The use of Taltz will benefit you by reducing disease symptoms and improving physical function.

2. What you should 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, ask your doctor for advice 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 using Taltz:

if you currently have an infection or have repeated or long-lasting 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 type of treatment for psoriasis (such as an immunosuppressant or ultraviolet light phototherapy) or for psoriatic arthritis.

Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Stop using Taltz and contact your doctor or seek immediate medical help if you experience
abdominal pain and cramps, diarrhoea, weight loss or blood in your stools (any sign of intestinal problems).
If you are unsure whether any of the above conditions apply to you, discuss this with your doctor or
nurse before using Taltz.
Be aware of infections and allergic reactions
Taltz may potentially cause serious side effects, including infections and allergic reactions.
You should pay attention to signs of these conditions while being treated with Taltz.
Stop using Taltz and inform your doctor or seek immediate medical help if you notice any sign
indicating a serious infection or an allergic reaction. These signs are listed in section 4 under “Serious side 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 currently using, have recently used, or might use any other medicines.
if you have recently been vaccinated or are due to be vaccinated. Certain types of vaccines should not be administered while you are using Taltz.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning 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 age, you will be advised to avoid pregnancy and to use an effective method of contraception during treatment with Taltz and for at least 10 weeks after the last dose of Taltz.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using this medicine.
You and your doctor will need to decide whether you can breastfeed or use Taltz. You should not do both.
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 (23 mg) of sodium per 40 mg dose, i.e.
essentially "sodium-free".
Taltz contains polysorbate
This medicine contains 0.15 mg of polysorbate 80 in each 40 mg pre-filled syringe, equivalent to 0.30 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Taltz

Use this medicine exactly as instructed by your doctor or nurse. If you have
any doubts, consult your doctor, nurse, or pharmacist.
Taltz is administered via an injection under the skin (subcutaneous injection). You and your
doctor or nurse should decide whether you can self-inject Taltz.
For use in children with a body weight of 25–50 kg, a dose of ixekizumab 40 mg should be administered. The 40 mg dose should be given using the 40 mg pre-filled syringe, or it should be prepared from an 80 mg pre-filled syringe by a qualified healthcare professional.
It is important that you do not attempt to self-inject the medicine until you have received adequate
instructions from your doctor or a nurse. A caregiver may also inject Taltz for you after receiving adequate
instructions.
Use a reminder method, such as a note on a calendar or diary, to help you remember the next dose to avoid forgetting or repeating administration of the medicine.
Taltz is used for long-term treatment. Your doctor or nurse will regularly monitor your condition to ensure the treatment is having the desired effect.
Each syringe contains one dose of Taltz (40 mg). Each syringe delivers a single dose. The syringe must not be shaken.
Carefully read the “Instructions for Use” for the syringe before using Taltz.
How much Taltz is administered and for how long
Your doctor will explain to you how much Taltz you need and for how long.
Plaque psoriasis in adults

The initial dose is 160 mg via subcutaneous injection. This injection may be administered by your doctor or nurse.
After the initial dose, you will use an 80 mg dose at weeks 2, 4, 6, 8, 10, and 12. From week 12 onwards, you will use an 80 mg dose every 4 weeks.

Plaque psoriasis in patients aged 6 years and older with a body weight of at least 25 kg.
Juvenile idiopathic arthritis in patients aged 6 years and older with a body weight of at least 25 kg.
The recommended dose administered by subcutaneous injection in children is based on the following body weight categories:
Child’s body weight Recommended initial dose Recommended subsequent dose
(week 0) every 4 weeks (Q4W)
Greater than 50 kg 160 mg 80 mg
25 to 50 kg 80 mg 40 mg
The use of Taltz is not recommended 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 initial dose is 160 mg via subcutaneous injection. This injection may be administered by your doctor or nurse.
after the initial dose, you will use an 80 mg dose at weeks 2, 4, 6, 8, 10, and 12. From week 12 onwards, you will use an 80 mg dose every 4 weeks.

For other patients with psoriatic arthritis:

the initial dose is 160 mg via subcutaneous injection. This injection may be administered by your doctor or nurse.
after the initial dose, you will use an 80 mg dose every 4 weeks.

Axial spondyloarthritis
The recommended dose is 160 mg via subcutaneous injection at week 0, followed by 80 mg every 4 weeks.
If you use more Taltz than you should
If you have received more Taltz than prescribed or the dose was administered earlier than scheduled, inform your doctor.
If you forget to use Taltz
If you have missed an injection of Taltz, inform your doctor.
If you stop using Taltz
You must not stop treatment with Taltz without first discussing it with your doctor. If you stop treatment, symptoms of psoriasis or psoriatic arthritis may return.
If you have any questions about the use of this medicine, consult 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 using Taltz and contact your doctor or seek immediate medical help if you experience any of the following side 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 warm, red and painful, or a painful blistering rash

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, with redness or raised bumps

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 runny nose
reactions at the injection site (for example, 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
oral, skin and mucosal herpes (herpes simplex, mucocutaneous)

Uncommon (may affect up to 1 in 100 people)

oral thrush (oral candidiasis)
influenza
runny nose
bacterial skin infection
hives
itchy, watery, red and swollen eyes (conjunctivitis)
signs of low white blood cell count, such as fever, sore throat or mouth ulcers, due to infections (neutropenia)
low platelet count in the blood (thrombocytopenia)
eczema
painful, itchy, fluid-filled blisters (dyshidrotic eczema)
rash
rapid swelling of the tissues in the neck, face, mouth or throat (angioedema)
abdominal pain and cramps, diarrhoea, weight loss or blood in the stools (signs of intestinal problems)

Rare (may affect up to 1 in 1,000 people)

fungal infection of the oesophagus (oesophageal candidiasis)
red, peeling skin (exfoliative dermatitis)

Additional side effects in children and adolescents
Common (may affect up to 1 in 10 people)

influenza
runny nose
hives
eye discharge with itching, redness and swelling (conjunctivitis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 syringe label and on the
carton after “Exp”. The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C – 8 °C). Do not freeze. Do not place against the back panel of the
refrigerator.
Keep in the original packaging to protect the medicine from light.
Taltz may be kept out of the refrigerator for up to 5 days at a temperature not exceeding 30 ºC.
Do not use this medicine if you notice that the syringe is damaged or if the solution is cloudy, clearly
brown, or contains particles.
This medicine is for single use only.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Taltz contains

The active substance is ixekizumab. Each pre-filled syringe contains 40 mg of ixekizumab in 0.5 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”).

Description of the appearance of Taltz and contents of the pack
Taltz is a solution in a clear glass syringe. The colour may vary from colourless to slightly yellow.
Pack containing 1 pre-filled syringe.

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.

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Instructions for use

Taltz 40 mg solution for injection in pre-filled syringe

ixekizumab

Illustration of a horizontal medical device with a transparent body showing an internal green piston and two white ends with handles

Before using the pre-filled syringe:
Important information to know

Before using Taltz pre-filled syringe, read and carefully follow all instructions step by step. Keep these Instructions for Use and refer to them as needed.
The pre-filled syringe contains 1 dose of Taltz. The syringe is for single use only.
Do not shake the syringe.
Your doctor, pharmacist, or nurse can help you decide where on your body to give the injection.
Read the Package Leaflet inside this package for more information about the medicine.

INSTRUCTIONS FOR USE
Before using Taltz pre-filled syringe, read and carefully follow all instructions step by step.
Guide to components
Thumb
Green plunger
Grip
1 PREPARATION
1a Take the syringe out of the refrigerator. Leave the needle cap on the syringe
Syringe barrel Grey plunger
with medicine of syringe
Needle
Needle cap

Gray circular icon with a thick border and four tick marks indicating time division into two equal halves with one white and one gray section

until you are ready to give the injection. Wait 30 minutes to allow the syringe to reach room temperature before use.
DO NOT use any external heat source to warm the medicine, for example: a microwave oven, hot water, or direct sunlight.
1b Prepare the items needed for the injection:

1 alcohol swab
1 cotton ball or gauze pad
1 sharps disposal container for proper disposal of the syringe.

A hand holding a cylindrical medical device with a black indicator highlighted by a red circle and a black arrow pointing downward

1c Inspect the pre-filled syringe to make sure
it is not damaged externally. Leave the needle cap on the syringe until you are ready to give the injection. Check the label. Make sure the label shows the name Taltz.
The medicine inside should be clear. Its color may vary from colorless to slightly yellow.
DO NOT USE the syringe and dispose of it as instructed if you notice any of the following:

the expiry date has passed.
the syringe appears damaged.
the medicine is cloudy, clearly brown, or contains small particles.

1d Wash your hands before injecting the medicine.
1e Choose the injection site.

Diagram of two human figures showing orange application areas on arms, abdomen, and thighs with directional arrows for medical treatment

You may inject the medicine into the abdomen (stomach area), thigh, or the back of the upper arm. To inject into the upper arm, you will need someone to help you.
DO NOT inject into areas where the skin is tender, bruised, red, hard, scarred, or has stretch marks. DO NOT inject within 2.5 cm of the navel.
Rotate the injection site. DO NOT inject exactly in the same spot each time.
For example, if your last injection was in the left thigh, your next injection should be in the right thigh, abdomen, or back of an arm.
Abdomen
Thigh
1f Prepare the skin. Clean the skin with the alcohol swab. Allow the injection site to dry naturally before injecting the medicine.
2 INJECTION

Two hands holding a syringe with a white plunger being pulled to the right, indicated by a red arrow, to aspirate liquid

2a Remove and discard the needle cap.
DO NOT replace the needle cap – doing so may damage the needle or cause accidental injury.
DO NOT touch the needle.
2b
Gently pinch and hold the area of skin
where you will give the injection.

A hand pinching the skin of the arm between two red arrows pointing inward

A hand holding a syringe to insert it into the buttock at a 45-degree angle indicated by a diagonal red line and a black 90-degree reference line

Insert the needle at a 45-degree angle to administer the medicine under the skin (subcutaneous injection). Then gently release the skin. Make sure to keep the needle in place.
Release the skin before
pressing the plunger.

A hand holding a syringe with needle pointing toward the side of a nude torso for an injection

A hand holding a syringe for an injection

2d Push the plunger.
Slowly push the plunger all the way down until all the medicine has been injected. The grey plunger of the syringe must be fully depressed to the end of the syringe barrel. Gently remove the needle from the skin.
Press a cotton ball or gauze pad over the injection site. DO NOT rub the injection site, as this may cause bruising. Mild bleeding may occur. This is normal.
Green plunger
At the end of the injection, you should see the
rod
grey plunger of the syringe fully depressed at the end of the syringe barrel.
Grey plunger
of syringe
3 COMPLETION
3a Dispose of the pre-filled syringe.

A hand holding a syringe with needle preparing to dispose of it into a biohazard waste container with a biological risk symbol

DO NOT replace the needle cap. Dispose of the syringe in a sharps disposal container or as instructed by your doctor, pharmacist, or nurse.
When disposing of syringes and the sharps disposal container:

Dispose of the syringe in a shar游戏副本

Patient information leaflet

Taltz 80 mg solution for injection in pre-filled syringe

ixekizumab
Please read this entire leaflet carefully before using this medicine, as 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Taltz is and what it is used for
What you need to know before using Taltz
How to use Taltz
Possible side effects
How to store Taltz
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 indicated for the treatment of 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
radiographic axial spondyloarthritis in adults
non-radiographic axial spondyloarthritis in adults
juvenile idiopathic arthritis, including juvenile psoriatic arthritis and enthesitis-related arthritis, in patients aged 6 years and older with a body weight of at least 25 kg

Plaque psoriasis
Taltz is used to treat a skin condition called "plaque psoriasis" of moderate to severe degree in adults, in children from 6 years of age and with a body weight of at least 25 kg, and in adolescents. Taltz reduces the signs and symptoms of the disease.
Treatment with Taltz will benefit you by improving skin manifestations and reducing symptoms such as scaling, itching, and pain.

Psoriatic arthritis
Taltz is used in adults for the treatment of a condition called "psoriatic arthritis", an inflammatory joint disease, often associated with psoriasis. If you have psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines or if you experience intolerance, Taltz will be prescribed to reduce the signs and symptoms of the disease. Taltz may be used alone or in combination with another medicine called methotrexate.
Treatment with Taltz will benefit you by reducing the signs and symptoms of the disease, improving physical function (ability to perform normal daily activities), and slowing joint damage.

Axial spondyloarthritis
Taltz is used in adults for the treatment of an inflammatory disease that primarily affects the spine, causing inflammation of the spinal joints, called "axial spondyloarthritis".
When the disease is visible on X-rays, it is defined as "radiographic axial spondyloarthritis"; when it occurs in patients without visible signs on X-rays, it is defined as "non-radiographic axial spondyloarthritis". If you have axial spondyloarthritis, you will first be treated with other medicines. If you do not respond adequately to these treatments, Taltz will be prescribed to reduce the signs and symptoms of the disease, reduce inflammation, and improve physical function.

Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis
Taltz is used in patients aged 6 years and older with a body weight of at least 25 kg for the treatment of conditions within the category of juvenile idiopathic arthritis known as "juvenile psoriatic arthritis" and "enthesitis-related arthritis". These conditions are inflammatory diseases affecting the joints and the sites where tendons attach to bone.
Treatment with 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, ask your doctor for advice 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 using Taltz:

if you currently have an infection or if you have repeated or long-lasting 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 type of treatment for psoriasis (such as an immunosuppressant or ultraviolet light phototherapy) or for psoriatic arthritis.

Inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
Stop using Taltz and contact your doctor or seek immediate medical attention if you experience
abdominal pain and cramps, diarrhoea, weight loss or blood in the stool (any sign of intestinal problems).
If you are unsure whether any of the above conditions apply to you, discuss them with your doctor or
nurse before using Taltz.
Be aware of infections and allergic reactions
Taltz may potentially cause serious side effects, including infections and allergic reactions.
You should be alert to signs of these conditions while being treated with Taltz.
Stop using Taltz and inform your doctor or seek immediate medical help if you notice any sign
indicating a serious infection or an allergic reaction. These signs are listed in section 4 under “Serious side 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 currently taking, have recently taken, or might take any other medicines.
if you have recently been vaccinated or are due to be vaccinated. Certain types of vaccines should not be administered while you are using Taltz.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, 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 will be advised to avoid pregnancy and to use an effective method of contraception during treatment with Taltz and for at least 10 weeks after the last dose of Taltz.
If you are breastfeeding or plan to breastfeed, talk to your doctor before using this medicine. You and your doctor will need to decide whether you can breastfeed or use Taltz. You must not do both.
Driving and using machines
It is unlikely that Taltz will affect your ability to drive or use machinery.
Taltz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 80 mg dose, i.e.
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 known allergies.

3. How to use Taltz

Use this medicine exactly as instructed by your doctor or nurse. If you have
any doubts, consult your doctor, nurse, or pharmacist.
Taltz is administered by injection under the skin (subcutaneous injection). You and your
doctor or nurse should decide whether you can self-inject Taltz.
For use in children weighing 25–50 kg, 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.
It is important that you do not attempt to inject the medicine yourself until you have received
adequate instructions from your doctor or a nurse. A caregiver may also inject Taltz for you
after receiving proper training.
Use a reminder method, such as marking a calendar or diary, to help you remember when your next dose is due, so as to avoid missing or repeating a dose.
Taltz is intended for long-term treatment. Your doctor or nurse will regularly monitor your condition to ensure the treatment is having the desired effect.
Each syringe contains one dose of Taltz (80 mg). Each syringe delivers a single dose. Do not shake the syringe.
Carefully read the “Instructions for Use” for the syringe before using Taltz.

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

Plaque psoriasis in adults

The initial dose is 160 mg given by subcutaneous injection. This injection may be administered by your doctor or nurse.
After the initial dose, you will receive 80 mg at weeks 2, 4, 6, 8, 10, and 12. Starting at week 12, you will receive 80 mg every 4 weeks.

Child’s body weight Recommended initial dose (week 0) Recommended subsequent dose every 4 weeks (Q4W)

50 kg 160 mg (2 syringes) 80 mg (1 syringe)
25–50 kg 80 mg (1 syringe) 40 mg (dose preparation required if the 40 mg pre-filled syringe is not available)

Preparation of 40 mg ixekizumab for 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 initial dose is 160 mg by subcutaneous injection. This injection may be administered by your doctor or nurse.
After the initial dose, you will receive 80 mg at weeks 2, 4, 6, 8, 10, and 12. Starting at week 12, you will receive 80 mg every 4 weeks.

For other patients with psoriatic arthritis:

The initial dose is 160 mg by subcutaneous injection. This injection may be administered by your doctor or nurse.
After the initial dose, you will receive 80 mg every 4 weeks.

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

If you use more Taltz than you should
If you have received more Taltz than prescribed or the dose was administered earlier than scheduled, inform your doctor.

If you forget to use Taltz
If you have missed an injection of Taltz, inform your doctor.

If you stop using Taltz
Do not stop treatment with Taltz without first discussing it with your doctor. If you stop treatment, symptoms of psoriasis or psoriatic arthritis may return.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Stop using Taltz and contact your doctor or seek immediate medical help if you experience
any of the following side 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 warm, red and painful, or a 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 feeling lightheaded
swelling of the face, lips, tongue or throat
severe itching of the skin, with redness or raised bumps

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 runny nose
reactions at the injection site (for example, 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
oral, skin and mucosal herpes (herpes simplex, mucocutaneous)

Uncommon (may affect up to 1 in 100 people)

oral thrush (oral candidiasis)
influenza
runny nose
bacterial skin infection
hives
eye discharge with itching, redness and swelling (conjunctivitis)
signs of low white blood cell count, such as fever, sore throat or mouth ulcers, due to infections (neutropenia)
low platelet count in the blood (thrombocytopenia)
eczema
painful, itchy fluid-filled blisters (dyshidrotic eczema)
rash
rapid swelling of the tissues in the neck, face, mouth or throat (angioedema)
abdominal pain and cramps, diarrhoea, weight loss or blood in the stools (signs of intestinal problems)

Rare (may affect up to 1 in 1,000 people)

fungal infection of the oesophagus (oesophageal candidiasis)
red, peeling skin (exfoliative dermatitis)

Additional side effects in children and adolescents
Common (may affect up to 1 in 10 people)

influenza
runny nose
hives
eye discharge with itching, redness and swelling (conjunctivitis)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 on the carton after "Exp". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Do not place against the back wall 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 ºC.
Do not use this medicine if you notice that the syringe is damaged or if the solution is cloudy, clearly brown, or contains particles.
This medicine is for single use only.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Taltz contains

The active substance is ixekizumab. Each pre-filled syringe contains 80 mg of ixekizumab in 1 mL of solution.
The other ingredients 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”).

Description of the appearance of Taltz and contents of the pack
Taltz is a solution in a transparent glass syringe. The colour may vary from colourless to
slightly yellow.
Packs of 1, 2 or 3 pre-filled syringes. Not all pack sizes may be marketed in your country.

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.

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf.: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: + 371 67364000

Further information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu

The following information is intended exclusively for medical or healthcare professionals:

Preparation of the 40 mg ixekizumab dose for pediatric patients weighing 25–50 kg
If the 40 mg pre-filled syringe is not available, 40 mg doses of ixekizumab must be prepared and administered by a qualified healthcare professional. Use only Taltz 80 mg solution for injection in pre-filled syringe to prepare the prescribed pediatric 40 mg doses.

Transfer the entire content of the pre-filled syringe into a sterile, clear glass vial. DO NOT shake or rotate the vial.
Use a single-use 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.
Replace the needle and use a sterile 27-gauge needle to administer the injection to the patient. Dispose of any unused medicinal product remaining in the vial.

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

Instructions for use

Taltz 80 mg solution for injection in pre-filled syringe

ixekizumab

Illustration of a syringe-shaped medical device with a white body, transparent cylinder containing blue liquid, and green plunger

Before using the pre-filled syringe:
Important information to know

Before using Taltz pre-filled syringe, read and carefully follow all instructions step by step. Keep these Instructions for Use and refer to them as needed.
The pre-filled syringe contains 1 dose of Taltz. The syringe is for SINGLE use ONLY.
Do not shake the syringe.
Your doctor, pharmacist, or nurse can help you decide where on your body to give the injection.
Read the Taltz Package Leaflet inside this package for more information about this medicine.

INSTRUCTIONS FOR USE
Before using the Taltz pre-filled syringe, read and carefully follow all instructions step by step.
Guide to components
Thumb
press button

Technical diagram of a medical device with a green plunger, transparent body, thin tip, and white base with black reference lines

Green
plunger
rod
1 PREPARATION
1a Remove the syringe from the refrigerator. Keep the needle cap on the syringe
Grip
Gray
plunger
Syringe
body with
medication
Needle
Needle
cap

Gray circular icon with a thick border and four internal tick marks indicating time division into two equal halves with a white and light gray background

1b Prepare the items needed for the injection:

1 alcohol swab
1 cotton ball or gauze pad
1 sharps disposal container for proper disposal of the syringe.

1c Inspect the pre-filled syringe to ensure it is not damaged externally. Keep the needle cap on the syringe until you are ready to give the injection. Check the label. Make sure the label shows the name Taltz.
The medicine inside should be clear. The color may vary from colorless to slightly yellow.
If you notice any of the following, DO NOT USE the syringe and dispose of it as instructed:

the expiration date has passed.
the syringe appears damaged.
the medicine is cloudy, clearly brown, or contains small particles.

1d Wash your hands before injecting the medicine.
1e Choose the injection site.

Diagram of two human figures indicating drug application sites with orange patches on arms, abdomen, and thighs

The medicine can be injected into the abdomen (stomach area), thigh, or the back of the upper arm. To inject into the arm, you will need someone to help you.
DO NOT inject in areas where the skin is tender, bruised, red, hard, scarred, or has stretch marks. DO NOT inject within 2.5 centimeters around the navel.
Alternate the injection site. DO NOT inject in exactly the same spot each time. For example, if the last injection was in the left thigh, the next injection should be in the right thigh, the abdomen, or the back of an arm.

1f Prepare the skin. Clean the skin with the alcohol swab. Allow the injection site to dry naturally before injecting the medicine.

2 INJECTION
2a Remove and discard the needle cap.

Two hands holding a syringe to attach the needle

DO NOT replace the needle cap—doing so may damage the needle or cause accidental injury.
DO NOT touch the needle.

2b Gently pinch and hold the area of skin where the injection will be given.

A hand pinching the skin of the arm between thumb and index finger with two red arrows indicating inward pressure

2c Insert the needle at a 45-degree angle. Then gently release the skin. Make sure to keep the needle in place.

A hand holding a syringe to inject medication into the body at a 45-degree angle relative to the skin as indicated by graphic symbols

A hand holding a syringe with a green plunger to inject liquid through the needle

2d Push the plunger.
Slowly push the plunger all the way down until all the medicine has been injected. The gray plunger of the syringe should be fully depressed to the end of the syringe. Gently remove the needle from the skin.
Apply a cotton ball or gauze pad to the injection site. DO NOT rub the injection site, as this may cause bruising. Mild bleeding may occur. This is normal.
When the injection is complete, you should see the green plunger rod through the body of the syringe.

3 COMPLETION
3a Dispose of the pre-filled syringe.

dispose of the syringe in a sharps disposal container or as instructed by your doctor, pharmacist, or nurse.
do not recycle the sharps disposal container.
ask your doctor, pharmacist, or nurse how to dispose of medicines you no longer use.

Safety tips

If you have questions or need help with the pre-filled syringe, contact your doctor, pharmacist, or nurse.
If you have vision problems, DO NOT use the pre-filled syringe without help from someone who has been properly trained in its use.
DO NOT share or reuse the Taltz pre-filled syringe. This may transmit or cause an infection.
Keep the syringe out of sight and reach of children.
If you do not have a sharps disposal container, ask your doctor, pharmacist, or nurse where you can obtain one.

Frequently asked questions
Q. What if I see an air bubble in my syringe?
A. It is normal to sometimes have air bubbles in the syringe. Taltz is injected subcutaneously (subcutaneous injection). Air bubbles are not a problem with this type of injection. They are not dangerous and will not affect the dose.

Q. What if there is a drop of liquid at the tip of the needle when I remove the needle cap?
A. It is normal to see a drop of liquid at the tip of the needle. This is not dangerous and will not affect the dose.

Q. What if I cannot push the plunger?
A. If the plunger is stuck or damaged:

DO NOT continue using the syringe.
remove the needle from the skin.

Q. How do I know when the injection is complete?
A. When the injection is complete:

the green plunger rod should be visible through the body of the syringe.
the gray plunger of the syringe should be fully depressed to the end of the syringe.

Q. What if the syringe is left at room temperature for more than 30 minutes?
A. If necessary, the syringe may be kept outside the refrigerator at a temperature not exceeding 30°C for up to 5 days, provided it is protected from direct sunlight. Taltz must be discarded if not used within 5 days at room temperature.
Read all Instructions for Use and the Package Leaflet inside this package for more information about this medicine.

Patient information leaflet

Taltz 80 mg solution for injection in pre-filled pen

ixekizumab
Please read this leaflet carefully before 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 other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Taltz is and what it is used for
What you need to know before using Taltz
How to use Taltz
Possible side effects
How to store Taltz
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 indicated for the treatment of the following inflammatory diseases:

plaque psoriasis in adults
plaque psoriasis in children from 6 years of age and weighing at least 25 kg, and in adolescents
psoriatic arthritis in adults
radiographic axial spondyloarthritis in adults
non-radiographic axial spondyloarthritis in adults
juvenile idiopathic arthritis, including juvenile psoriatic arthritis and enthesitis-related arthritis, in patients aged 6 years and older and weighing at least 25 kg

Plaque psoriasis
Taltz is used to treat a skin condition called "plaque psoriasis" of moderate to severe degree in adults, children from 6 years of age and weighing at least 25 kg, and in adolescents. Taltz reduces the signs and symptoms of the disease.
The use of Taltz will benefit you by improving skin manifestations and reducing symptoms such as scaling, itching, and pain.

Psoriatic arthritis
Taltz is used in adults for the treatment of a condition called "psoriatic arthritis", an inflammatory joint disease, often accompanied by psoriasis. If you have psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines or if you are intolerant to them, Taltz will be prescribed to reduce the signs and symptoms of the disease. Taltz may be used alone or in combination with another medicine (called methotrexate).
The use of Taltz will benefit you by reducing the signs and symptoms of the disease, improving physical function (ability to perform normal daily activities), and slowing joint damage.

Axial spondyloarthritis
Taltz is used in adults for the treatment of an inflammatory disease that primarily affects the spine, causing inflammation of the spinal joints, called "axial spondyloarthritis". If the disease is visible on X-rays, it is defined as "radiographic axial spondyloarthritis"; if it occurs in patients without visible signs on X-rays, it is defined as "non-radiographic axial spondyloarthritis". If you have axial spondyloarthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, Taltz will be prescribed to reduce the signs and symptoms of the disease, reduce inflammation, and improve physical function.

Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis
Taltz is used in patients aged 6 years and older and weighing at least 25 kg for the treatment of conditions falling within the categories of juvenile idiopathic arthritis called "juvenile psoriatic arthritis" and "enthesitis-related arthritis". These conditions are inflammatory diseases affecting the joints and the sites where tendons attach to bone.
The use of 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, ask your doctor for advice 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 using Taltz:

if you currently have an infection or if you have recurrent or long-lasting 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 type of treatment for psoriasis (such as an immunosuppressant or ultraviolet light phototherapy) or for psoriatic arthritis.

Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Stop using Taltz and contact your doctor or seek immediate medical help if you experience
abdominal pain and cramps, diarrhoea, weight loss or blood in your stools (any sign of intestinal problems).
If you are unsure whether any of the conditions listed above apply to you, discuss this with your doctor or
nurse before using Taltz.
Be aware of infections and allergic reactions
Taltz may potentially cause serious side effects, including infections and allergic reactions.
You should be alert to signs of these conditions while being treated with Taltz.
Stop using Taltz and contact your doctor or seek immediate medical help if you notice
any signs indicating a serious infection or an allergic reaction. These signs are listed
in section 4 under “Serious unwanted 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 take any other medicines.
if you have recently been vaccinated or are due to be vaccinated. Certain 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 are planning a pregnancy, 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 will be advised to avoid pregnancy and to use an effective method of contraception during treatment with Taltz and for at least 10 weeks after the last dose of Taltz.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using this medicine. You and your doctor will need to decide whether you can breastfeed or use Taltz. You must not do both.

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 (23 mg) of sodium per 80 mg dose, i.e. 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 known allergies.

3. How to use Taltz

Use this medicine exactly as instructed by your doctor or nurse. If you have
any doubts, consult your doctor, nurse, or pharmacist.
Taltz is administered by injection under the skin (subcutaneous injection). You and your
doctor or nurse should decide whether you can self-inject Taltz.
For use in children with a body weight of 25–50 kg, ixekizumab 40 mg doses 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 self-inject the medicine until you have received adequate
instructions from your doctor or a nurse. A caregiver may also administer Taltz after receiving
adequate instructions.
Use a method, such as a notation on a calendar or diary, to help you remember your next dose to avoid
forgetting or repeating administration of the medicine.
Taltz is used for long-term treatment. Your doctor or nurse will regularly monitor your condition to ensure the treatment is having the desired effect.
Each pen contains one dose of Taltz (80 mg). Each pen delivers a single dose. Do not shake the pen.
Carefully read the “Instructions for Use” for the pen before using Taltz.

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

Plaque psoriasis in adults

The initial dose is 160 mg (2 pens of 80 mg each) by subcutaneous injection. This injection may be administered by your doctor or nurse.
After the initial 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.

Child’s body weight Recommended initial dose Recommended subsequent dose every 4 weeks (Q4W)

50 kg 160 mg (2 pens) 80 mg (1 pen)
25–50 kg 80 mg (1 pen) 40 mg (dose preparation required if
pre-filled 40 mg syringe is not
available)

If the pre-filled 40 mg syringe is not available, ixekizumab 40 mg doses must be
prepared and administered by a qualified healthcare professional using the commercially available Taltz 80 mg pre-filled syringe.
Use the Taltz 80 mg pre-filled pen only in children who require an 80 mg dose. Do not use the Taltz 80 mg pre-filled pen for preparing a 40 mg dose.
The use of Taltz is not recommended 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 initial dose is 160 mg (2 pens of 80 mg each) by subcutaneous injection. This injection may be administered by your doctor or nurse.
After the initial 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.

For other patients with psoriatic arthritis:

The initial dose is 160 mg (2 pens of 80 mg each) by subcutaneous injection. This injection may be administered by your doctor or nurse.
After the initial 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 the dose was administered earlier than prescribed,
inform your doctor.

If you forget to use Taltz
If you have missed an injection of Taltz, inform your doctor.

If you stop using Taltz
Do not stop treatment with Taltz without first talking to your doctor. If you stop
treatment, symptoms of psoriasis or psoriatic arthritis may return.
If you have any questions about how to use this medicine, consult 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 using Taltz and contact your doctor or seek immediate medical help if you experience
any of the following side 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 warm, red and painful, or a painful 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 feeling lightheaded
swelling of the face, lips, tongue or throat
severe itching of the skin, with redness or raised bumps

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 runny nose
reactions at the injection site (for example, 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
oral, skin and mucosal herpes (herpes simplex, mucocutaneous)

Uncommon (may affect up to 1 in 100 people)

oral thrush (oral candidiasis)
influenza
runny nose
bacterial skin infection
hives
itchy eye discharge with redness and swelling (conjunctivitis)
signs of low white blood cell counts, such as fever, sore throat or mouth ulcers, due to infections (neutropenia)
low platelet count in the blood (thrombocytopenia)
eczema
painful, itchy, fluid-filled blisters (dyshidrotic eczema)
rash
rapid swelling of the tissues in the neck, face, mouth or throat (angioedema)
abdominal pain and cramps, diarrhoea, weight loss or blood in the stools (signs of intestinal problems)

Rare (may affect up to 1 in 1,000 people)

fungal infection of the oesophagus (oesophageal candidiasis)
red, peeling skin (exfoliative dermatitis)

Additional side effects in children and adolescents
Common (may affect up to 1 in 10 people)

influenza
runny nose
hives
eye discharge with itching, redness and swelling (conjunctivitis)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 pen label and the carton after "Exp". The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C – 8 °C). Do not freeze. Do not place against the back panel of the refrigerator.
Keep in the original packaging to protect the medicine 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 solution is cloudy, clearly brown, or contains particles.
This medicine is for single use only.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Taltz contains

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 have been added to adjust the pH (see section 2 “Taltz contains sodium” and “Taltz contains polysorbate”).

Description of the appearance of Taltz and contents of the pack
Taltz is a solution in a clear glass syringe. The colour may vary from colourless to slightly yellow.
The syringe is contained within a single-use, single-dose pen.
Packs containing 1, 2 or 3 pre-filled pens. Not all pack sizes may be marketed in your country.

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.

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf.: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.B.E. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780