InfoCons Consumer Protection informs you – Taltz – Package Leaflet
Taltz – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Taltz, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Taltz is and what it is used for
Taltz contains the active substance ixekizumab .
Taltz is intended for the treatment of the inflammatory diseases described below:
- Plaque psoriasis in adults
- Plaque psoriasis in children from the age of 6 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 enthesitis-related arthritis and juvenile psoriatic arthritis , in patients from the age of 6 years and older and with a body weight of at least 25 kg Ixekizumab belongs to a group of medicines called interl eukin (I L) inhibitors. This m edicine works by blocking the activity of a protein called IL-17A, whi ch promotes psoriasis and inflammatory disease of the joints and the spine .
Plaque psoriasis Taltz is used to treat a ski n condition call ed “plaque psoriasis ” in adult s and in children from the age of 6 years and with a body weight of at least 25 kg and in adolescents with m oderate to sever e disease. Taltz reduces t he signs and symptoms of t he disease.
Using Taltz will benefit you by improvem ents of ski n clearan ce and reducing y our symptom s such as scaling, itching and p ain.
Psoriatic arthritis Taltz is used to treat a condition called “psoriatic arthritis” in adults , an inflammatory disease of the joints, often accompanied by psoriasis. If you have psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines or in case of intolerance, you will be given Taltz to reduce the signs and symptoms of the disease. Taltz can be used alone or with another medicine named methotrexate.
Using Taltz will benefit you by reducing the signs and symptoms of the disease, improving physical function (ability to do normal daily activities), and slowing down the damage to the joints.
Axial spondyloarthritis Taltz is used to treat adults with an inflammatory disease primarily affecting the spine which causes inflammation of the spinal joints, called a xial spondyloarthritis. If the condition is visible using X-rays, it is referred to as “radiographic axial spondyloarthritis”; if it occurs in patients with no visible signs on X- rays, it is referred to as “non -radiographic a xial spondyloarthritis”. If you have a xial spondyloarthritis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Taltz to reduce the 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 the age of 6 years of age and older and with a body weight of at least 25 kg to treat the conditions of juvenile idiopathic arthritis called “juvenile psoriatic arthritis” and “enthesitis- related arthritis”. These conditions are inflammatory diseases affecting the joints and the places where tendons join the bone.
Using Taltz will benefit you by reducing the symptoms of the disease and improving your physical function.
⚠️ 2. What you need to know before you use Taltz
Do not use Taltz
- if you are allergic to ixekizumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice before using Taltz.
- if you have an infection which your doctor thinks is important (for example, active tuberculosis).
Warnings and precautions
Talk to your doctor before using Taltz:
- if you currently have an infection or if you have long- term or repeated infections.
- if you have an inflammatory disease affecting the gut named Crohn’s disease.
- if you have an inflammation of the large intestine named ulcerative colitis.
- if you are receiving any other treatment for psoriasis (such as immunosuppressant or phototherapy w ith ul traviol et light) or for psoriatic arthritis .
Inflammatory bowel disease (Crohn’s disease or ulcerative colitis) Stop using Taltz and tell your doctor or seek medical help immediately if you notice abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (any signs of bowel problems).
If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Taltz.
Look out for infecti ons a nd allergi c reactions Taltz can pot entially ca use serious sid e effect s, including infecti ons and allergi c reactions. You must look out for sig ns of these conditions whil e you are using Taltz .
Stop using Taltz and tell your doctor or se ek medical help imm ediately if you noti ce any sig ns of a seriou s infec tion or an allergic reaction. Such signs ar e listed under “Serious side eff ects” in section 4.
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 with a body weight below 25 kg because it has not been studied in this age group.
Other medicines and Taltz Tell your doctor, pharmacist or nurse
- if you are using, have recently used or might use any other medicine s.
- if you have recently had or are due to have a vaccination. You should not be given certain types of vaccines while using Taltz .
Pregnancy and breast -feeding If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. It is preferable to avoid the use of Taltz in pregnancy. The effects of this medicine in pregnant women are not known.
If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use effective contraception while using Taltz and for at least 10 weeks after the last Taltz dose.
If you are breast -feeding or are planning to breast -feed, talk to your doctor before using this medicine.
You and your doctor shoul d decide if you can br east-feed or use Taltz. You shou ld not do bo th.
Driving and using machines
Taltz is unlikely to influence your ability to drive and use machines .
Taltz contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 80 mg dose, that is to say essentially “sodium -free”.
Taltz contains polysorbate
This medicine contains 0.3 0 mg of polysorbate 80 in each 80 mg pre -filled pen, which is equivalent to 0.30 mg/mL . Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
💊 3. How to use Taltz
Always use this medicine exactly as your doc tor or nu rse has told you. C heck with your doctor, nurse or pharmacist if you are not sure.
Taltz is given by i njection und er your skin (subcutaneous injection) . You and your doc tor or nurse should decide if you shou ld inject Taltz yourself.
For use in children with a body weight of 25- 50 kg ixekizumab doses of 40 mg must be prepared and administered by a qualified healthcare professional.
Use the Taltz 80 mg pre -filled pen only in those children that require a dose of 80 mg and do not require dose preparation.
It is important not to try to inject yourself until you ha ve been trained by your doctor or nurse. A caregiver may also give you your Taltz injection after proper training.
Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you avoid missing or repeating doses.
Taltz is for long-term treatment. Your doctor or nurse will regularly monitor your condition to check that the treatment is having the desired effect.
Each pen contains one dose of Taltz (80 mg). Each pen delivers only one dose. The pen must not be shaken.
Read the “Instructions for use” for the pen carefully before using Taltz.
How mu ch Taltz is given and fo r how long Your doct or will explain to you how much Taltz you need and for how long.
Plaque psoriasis in adults
- The first dose is 160 mg (2 pens with 80 mg each) by subcutaneous injection. This may be given by your doctor or nur se.
- After the first dose, you wi ll use an 80 mg dose (1 pen ) at weeks 2, 4, 6, 8, 10, and 12. From week 12, y ou w ill use an 80 mg dose (1 pen ) every 4 weeks.
Plaque psoriasis in patients age 6 years and above and at least 25 kg body weight.
Juvenile idiopathic arthritis in patients age 6 years and above and at least 25 kg body weight.
The recommended dose given by subcutaneous injection in children is based on the following weight categories:
Children’s body weight Recommended starting dose ( week 0) Recommended dose every 4 weeks (Q4W) thereafter Greater than 50 kg 160 mg (2 pens) 80 mg (1 pen) 25 to 50 kg 80 mg (1 pen) 40 mg (dose preparation required if 40 mg syringe is not available ) 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 using the commercial Taltz 80 mg pre -filled syringe. Use the Taltz 80 mg pre-filled pen only in those children that require a dose of 80 mg. Do not use the Taltz 80 mg pre-filled pen for the preparation of the 40 mg dose.
Taltz is not recommended for use in children with a body weight below 25 kg.
Psoriatic arthritis For psoriatic arthritis patients who also have moderate to severe plaque psoriasis:
- The first dose is 160 mg (2 pens with 80 mg each) by subcutaneous injection. This may be given by your doctor or nur se.
- After the first dose, you wi ll use an 80 mg dose (1 pen ) at w eeks 2, 4, 6, 8, 10, and 12. From week 12, you will use an 80 mg dose ( 1 pen) every 4 weeks .
For other psoriatic arthritis patients
- The first dose is 160 mg (2 pens with 80 mg each) by subcutaneous injection. This may be given by your doctor or nurse.
- After the first dose you will use an 80 mg dose ( 1 pen) every 4 weeks.
Axial spondyloarthritis The recommended dose is 160 mg (2 pens with 80 mg each) by subcutaneous injection at w eek 0, followed by 80 mg (1 pen) every 4 weeks.
If you use more Taltz than you should
If you hav e received mor e Taltz than you should or the dos e has been given sooner t han prescribed, inform y our doctor.
If you forget to use Taltz
If you hav e forgott en to inject a dos e of Taltz , talk to your doctor.
If you stop using Taltz
You should not stop using Taltz without speaking to your doctor first. If you stop treatment, symptoms of psoriasis or psoriatic arthritis may come back.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop using Taltz and tell your doctor or seek medical help immediately if you get any of the following side effects. Your doctor will decide if and when you may restart the treatment:
Possible serious infection ( uncommon, may affect up to 1 in 100 people) – the signs may include:
- fever , flu-like symptoms, night sweats
- feeling tired or short of breath, cough which will not go away
- warm , red and painful skin, or a painful skin rash with blisters Serious allergic reaction (rare, may affect up to 1 in 1 000 people ) – the signs may include:
- difficulty breathing or swallowing
- low blood pressure, which can cause dizziness or light -head edness
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps
Other side effects that have been reported
Very common (may affect more than 1 in 10 people)
- upper respiratory tract infections with symptoms such as s ore throat and stuffy nose
- injection site reactions (e.g. red skin, pain)
Common (may affect up to 1 in 10 people)
- nausea
- fungal infections such as athlete’s foot
- pain in the back of the throat
- cold sores of mouth, skin and mucous membranes (herpes simplex, mucocutaneous)
Uncommon ( may affect up to 1 in 100 pe ople)
- oral thrush (oral candidiasis)
- influenza
- runny nose
- bacterial skin infection
- hives
- discharge from the eye with itching, redness and swelling (conjunctivitis)
- signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections (neutropenia)
- low blood platelet count ( thrombocytopenia)
- eczema
- painful, itchy and fluid- filled blisters (dyshidrotic eczema)
- rash
- rapid swelling of the tissues of the neck, face, mouth or throat (angioedema)
- abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems)
Rare (may affect up to 1 in 1 000 people)
- fungal infection of the oesophagus (oesophageal candidiasis)
- redness and peeling of the skin (exfoliative dermatitis)
Additional side effects in children and adolescents
Common (may affect up t o 1 in 10 people)
- influenza
- runny nose
- hives
- discharg e from the eye with itching, re dness and swelling ( conjunctiv itis).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects, you can help provide more information on the safety of this medicine.
🌡️ 5. 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 on the outer carton after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator ( 2 °C to 8 °C). Do not freeze. Do not push to the back panel of the fridge.
Store in the original packaging in order to protect from light.
Taltz can be left out of the fridge for up to 5 days at a temperature not above 30 º C.
Do not use this medicine if you notice that the pen is damaged, or the medicine is cloudy, distinctly brown, or has particles in it.
This medicine is f or single use only.
Do not throw away any medicines via wastewater. Ask your doctor, nurse or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Taltz contains
- The active substance is ixekizumab.
Each pre-filled pen contains 80 mg of ixekizumab in 1 mL solution.
- The other ingredients are sucrose; polysorbate 80; water for injection s. In addition, sodium
hydroxide may have been added for pH adjustment (see section 2 “Taltz contains sodium” and “Taltz contains polysorbate”) .
What Taltz looks like and contents of the pack
Taltz is a solution in a clear glass syringe. It s colour may vary from colourless to slightly yellow.
The syringe is encased in a disposable, single-dose pen.
Pack sizes of 1, 2, 3 pre- filled pens. Not all pack sizes may be available 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Belgique/België/Belgien Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32 -(0)2 548 84 84 Lietuva Eli Lilly Lietuva Tel. +370 (5) 2649600 България ТП “Ели Лили Недерланд ” Б.В. – България тел. + 359 2 491 41 40 Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32 -(0)2 548 84 84 Česká republika ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111 Magyarország Lilly Hungária Kft.
Tel: + 36 1 328 5100 Danmark Eli Lilly Danmark A/S Tlf.: +45 45 26 60 00 Malta Charles de Giorgio Ltd.
Tel: + 356 25600 500 Deutschland Lilly Deutschland GmbH Tel. + 49- (0) 6172 273 2222 Nederland Eli Lilly Nederland B.V.
Tel: + 31 -(0) 30 60 25 800 Eesti Eli Lilly Nederland B.V.
Tel: +372 6 817 280 Norge Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00 Ελλάδα ΦΑΡΜΑΣΕΡΒ -ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600 Österreich Eli Lilly Ges.m.b.H.
Tel: + 43 -(0) 1 711 780 España Lilly S.A.
Tel: + 34 -91 663 50 00 Polska Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00 France Lilly France Tél: +33 -(0) 1 55 49 34 34 Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600 Hrvatska Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999 România Eli Lilly România S.R.L.
Tel: + 40 21 4023000 Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353- (0) 1 661 4377 Slovenija Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10 Ísland Icepharma hf.
Sími + 354 540 8000 Slovenská republika Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111 Italia Eli Lilly Italia S.p.A.
Tel: + 39 – 055 42571 Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250 Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Sverige Eli Lilly Sweden AB Tel: + 46 -(0) 8 7378800 Latvija Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel: +371 67364000
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu . ————————————————————————————————————————– Instructions for use Taltz 80 mg solution for injection in pre -filled pen ixekizumab Before using your pre -filled pen:
Important points to know
- Before you use the Taltz pre -filled pen, read and carefully follow all the step -by-step instructions. Keep the Instructions for use and refer to them as needed.
- The pre -filled pen contains 1 dose of Taltz. The pre -filled pen is for ONE -TIME USE ONLY.
- The pre -filled pen must not be shaken.
- The pre -filled pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new pre -filled pen for your injection.
- Your doctor, pharmacist or nurse may help you decide where on your body to inject your dose.
- Read the Taltz Package Leaflet inside this box to learn more about your medicine.
INSTRUCTIONS FOR USE Before you use the Taltz pre -filled pen , read and carefully follow all the step -by-step instructions.
Guide to the parts 1 GET READY 1a Take the pre -filled pen from the refrigerator. Leave the base cap on until you are ready to inject. Wait 30 minutes to let the pre -filled pen warm to room temperature before you use it.
DO NOT use any heat sources to warm the medicine, for example: a
microwave, hot water, or direct sunlight.
1b Gather the supplies for your injection:
- 1 alcohol wipe
- 1 cotton ball or piece of gauze
- 1 sharps container for disposal of pre- filled pen Top Injection button Lock ring Lock/unlock symbols Medicine Clear base Twist -off base cap Bottom / End Needle minutes 1c Inspect the pre -filled pen. Check the label. Make sure the name Taltz appears on the label.
The medicine inside should be clear. Its colour may vary from colourless to slightly yellow.
If you see any of the following, DO NOT USE the pre-filled pen, and dispose of it as directed:
- It is past the expiry date.
- It looks damaged.
- The medicine is cloudy, is distinctly brown, or has small particles.
1d Wash your hands before you inject your medicine.
1e Choose your injection site.
You may inject in your abdomen (stomach area), in your thigh, or in the back of your arm. To inject in your arm, you will need someone to help you.
DO NOT inject into areas where the skin is tender, bruised, red, or hard or where you have scars or stretch marks. DO NOT inject within 2.5 centimetres of the navel (belly button).
Alternate your injection sites. DO NOT inject in the exact same spot every time. For example, if your last injection was in your left thigh, your next injection should be in your right thigh, your abdomen, or the back of either arm.
1f Prepare your skin. Clean your skin with an alcohol wipe. Let the injection site dry naturally before you inject your medicine.
Back of arm Abdomen Thigh Expiry date 2 INJECT 2a Make sure the lock ring is in the lock position.
Leave the base cap on until you are ready to inject. DO NOT touch the needle.
Twist off the base cap.
Throw the base cap in the bin. You will not need to put the base cap back on —doing so could damage the needle or cause you to injure yourself by accident.
2b Place the clear base flat and firmly against your skin.
2c Keep the base on your skin, and then turn the lock ring to the unlock position. You are now ready to inject.
2d Press the green injection button. There will be a loud click.
Keep holding the clear base firmly against your skin. You will hear a second loud click in about 5 to 10 seconds after the first one. The second loud click tells you that your injection is complete.
You will also see the grey plunger at the top of the clear base.
Remove the pre -filled pen from your skin.
Press a cotton ball or gauze over the injection site. DO NOT rub the injection site, as this may cause bruising.
You may have slight bleeding. This is normal.
3 FINISH 3a Dispose of the pre -filled pen.
DO NOT put the base cap back on. Dispose of the pre-filled pen in a sharps container or as directed by your doctor, pharmacist or nurse.
When you dispose of the pre -filled pen and the sharps container:
- Dispose of the pen in a sharps container or as directed by your doctor, pharmacist or nurse.
- Do not recycle the filled sharps container.
- Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.
Safety tips
- If you have questions or need help with your pre -filled pen, call your doctor, pharmacist or nurse.
- If you have vision problems, DO NOT use the pre -filled pen without help from a person trained to use it.
- Keep the pre -filled pen out of the reach and sight of children.
- If you do not have a sharps container, ask your doctor, pharmacist or nurse where you can get one. Grey plunger 5-10 seconds Click Commonly asked questions Q. What if I see air bubbles in the pre -filled pen?
A. It is normal to have air bubbles in the pre -filled pen. Taltz is injected under the skin (subcutaneous injection). Air bubbles are not a problem in this type of injection. They will not harm you or affect your dose.
Q. What if there is a drop of liquid on the tip of the needle when I remove the base cap?
A. It is okay to see a drop of liquid on the tip of the needle. This will not harm you or affect your dose.
Q. What if I unlocked the pre -filled pen and pressed the green injection button before I twisted off the base cap?
A. Do not remove the base cap. Contact your doctor, pharmacist or nurse.
Q. Do I need to hold the injection button down until the injection is complete?
A. This is not necessary, but it may help you keep the pre -filled pen steady and firm against your skin.
Q. What if the needle did not retract after my injection?
A. Do not touch the needle or replace the base cap. Dispose of the pre -filled pen in a closable, puncture -resistant sharps container. Contact your doctor, pharmacist or nurse.
Q. What if I heard more than 2 clicks during my injection —2 loud clicks and a soft one. Did I get my complete injection?
A. Some patients may hear a soft click right before the second loud click. That is normal. Do not remove the pre -filled pen from your skin until you hear the second loud click.
Q. How can I tell if my injection is complete?
A. After you press the green injection button, you will hear 2 loud clicks. The second click tells you that your injection is complete. You will also see the grey plunger at the top of the clear base.
Q. What if the pre-filled pen is left at room temperature for longer than 30 minutes?
A. If needed, the pre-filled pen may be left out of the fridge at temperature not above 30 °C for up to 5 days if protected from direct sunlight. T altz should be discarded if not used within the 5 day period at room temperature.
Read the full Instructions for use and the package leaflet inside this box to learn more about your medicine.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Taltz (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/15/1085).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.
