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Taltz (ixekizumab) – Package leaflet - L04

Updated on site: 10-Oct-2017

Medication nameTaltz
ATC CodeL04
Substanceixekizumab
ManufacturerEli Lilly Nederland B.V.

Article Contents

Package leaflet: Information for the patient

Taltz 80 mg solution for injection in pre-filled syringe ixekizumab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

What is in this leaflet

1.What Taltz is and what it is used for

2.What you need to know before you use Taltz

3.How to use Taltz

4.Possible side effects

5.How to store Taltz

6.Contents of the pack and other information

1.What Taltz is and what it is used for

Taltz contains the active substance ixekizumab.

Ixekizumab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising the activity of a protein called IL-17A, which promotes psoriasis.

Taltz is used to treat a skin condition called “plaque psoriasis” in adults with moderate to severe disease. Taltz reduces the signs and symptoms of the disease.

Using Taltz will benefit you by improvements of skin clearance and reducing your symptoms such as scaling, itching and pain.

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, nurse or pharmacist before using Taltz:

-if you currently have an infection or if you have long-term or repeated infections.

-if you have Crohn’s disease.

-if you have ulcerative colitis.

-if you are receiving any other treatment for psoriasis, such as immunosuppressant or phototherapy with ultraviolet light.

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 infections and allergic reactions

Taltz can potentially cause serious side effects, including infections and allergic reactions. You must look out for signs of these conditions while you are using Taltz.

Stop using Taltz and tell your doctor or seek medical help immediately if you notice any signs of a serious infection or an allergic reaction. Such signs are listed under “Serious side effects” in section 4.

Children and adolescents

Taltz is not recommended for children and adolescents under 18 years of age 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.

-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 adequate 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 should decide if you will breast-feed or use Taltz. You should not do both.

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, i.e., essentially “sodium- free”.

3.How to use Taltz

Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor, nurse or pharmacist if you are not sure how to use this medicine.

Taltz is given by injection under your skin (subcutaneous injection). You and your doctor or nurse should decide if you should inject Taltz yourself.

It is important not to try to inject yourself until you have been trained by your doctor or nurse. A caregiver may also give you your Taltz injection after proper training.

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

Read the “Instructions for Use” for the syringe carefully before using Taltz.

How much Taltz is given and for how long

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

-The first dose is 160 mg (two 80 mg injections) by subcutaneous injection. This may be given by your doctor or nurse.

-After the first dose, you will use an 80 mg dose (one injection) at Weeks 2, 4, 6, 8, 10, and 12. From Week 12, you will use an 80 mg dose (one injection) every 4 weeks.

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.

If you use more Taltz than you should

If you have received more Taltz than you should or the dose has been given sooner than prescribed, inform your doctor.

If you forget to use Taltz

If you have forgotten to inject a dose 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 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 (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 (frequency cannot be estimated from the available data) - the signs may include:

-difficulty breathing or swallowing

-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

Some side effects are very common (may affect more than 1 in 10 people):

-upper respiratory tract infections with symptoms such as sore throat and stuffy nose (nasopharyngitis).

-injection site reactions (e.g. red skin, pain).

Some side effects are common (may affect up to 1 in 10 people):

-nausea (feeling sick).

-tinea (fungal) infections such as athlete’s foot.

-pain in the back of the throat.

Some side effects are uncommon (may affect up to 1 in 100 people):

-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).

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 syringe 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 – 8 °C). Do not freeze.

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 ºC.

Do not use this medicine if you notice that the syringe is damaged, or the medicine is cloudy, distinctly brown, or has particles in it.

This medicine is for single use only.

Do not throw away any medicines via wastewater or household waste. 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 syringe contains 80 mg of ixekizumab in 1 ml solution.

-The other ingredients are sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for injections.

What Taltz looks like and contents of the pack

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

Pack sizes of 1, 2, 3 pre-filled syringes. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

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

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

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 Holdings Limited Eesti filiaal

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 SAS

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

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

--------------------------------------------------------------------------------------------------------------------------

Package leaflet: Information for the patient

Taltz 80 mg solution for injection in pre-filled pen ixekizumab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

What is in this leaflet

1.What Taltz is and what it is used for

2.What you need to know before you use Taltz

3.How to use Taltz

4.Possible side effects

5.How to store Taltz

6.Contents of the pack and other information

1. What Taltz is and what it is used for

Taltz contains the active substance ixekizumab.

Ixekizumab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising the activity of a protein called IL-17A, which promotes psoriasis.

Taltz is used to treat a skin condition called “plaque psoriasis” in adults with moderate to severe disease. Taltz reduces the signs and symptoms of the disease.

Using Taltz will benefit you by improvements of skin clearance and reducing your symptoms such as scaling, itching and pain.

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, nurse or pharmacist before using Taltz:

-if you currently have an infection or if you have long-term or repeated infections.

-if you have Crohn’s disease.

-if you have ulcerative colitis.

-if you are receiving any other treatment for psoriasis, such as immunosuppressant or phototherapy with ultraviolet light.

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 infections and allergic reactions

Taltz can potentially cause serious side effects, including infections and allergic reactions. You must look out for signs of these conditions while you are using Taltz.

Stop using Taltz and tell your doctor or seek medical help immediately if you notice any signs of a serious infection or an allergic reaction. Such signs are listed under “Serious side effects” in section 4.

Children and adolescents

Taltz is not recommended for children and adolescents under 18 years of age 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.

-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 adequate 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 should decide if you will breast-feed or use Taltz. You should not do both.

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, i.e., essentially “sodium- free”.

3. How to use Taltz

Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor, nurse or pharmacist if you are not sure how to use this medicine.

Taltz is given by injection under your skin (subcutaneous injection). You and your doctor or nurse should decide if you should inject Taltz yourself.

It is important not to try to inject yourself until you have been trained by your doctor or nurse. A caregiver may also give you your Taltz injection after proper training.

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 much Taltz is given and for how long

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

-The first dose is 160 mg (two 80 mg injections) by subcutaneous injection. This may be given by your doctor or nurse.

-After the first dose, you will use an 80 mg dose (one injection) at Weeks 2, 4, 6, 8, 10, and 12. From Week 12, you will use an 80 mg dose (one injection) every 4 weeks.

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.

If you use more Taltz than you should

If you have received more Taltz than you should or the dose has been given sooner than prescribed, inform your doctor.

If you forget to use Taltz

If you have forgotten to inject a dose 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 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 (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 (frequency cannot be estimated from the available data) - the signs may include:

-difficulty breathing or swallowing

-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

Some side effects are very common (may affect more than 1 in 10 people):

-upper respiratory tract infections with symptoms such as sore throat and stuffy nose (nasopharyngitis).

-injection site reactions (e.g. red skin, pain).

Some side effects are common (may affect up to 1 in 10 people):

-nausea (feeling sick).

-tinea (fungal) infections such as athlete’s foot.

-pain in the back of the throat.

Some side effects are uncommon (may affect up to 1 in 100 people):

-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).

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 – 8 °C). Do not freeze.

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 ºC.

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 for single use only.

Do not throw away any medicines via wastewater or household waste. 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 sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for injections.

What Taltz looks like and contents of the pack

Taltz is a solution in a clear glass syringe. Its 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 Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

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

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

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 Holdings Limited Eesti filiaal

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 SAS

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

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

--------------------------------------------------------------------------------------------------------------------------

Instructions for use

Taltz 80 mg solution for injection in pre-filled syringe

Ixekizumab

Before using your pre-filled syringe:

Important points to know

Before you use the Taltz pre-filled syringe, read and carefully follow all the step-by-step instructions. Keep the Instructions for Use and refer to them as needed.

The pre-filled syringe contains 1 dose of Taltz. The syringe is for ONE-TIME USE ONLY.

The syringe must not be shaken.

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 syringe, read and carefully follow all the step-by-step instructions.

Guide to the parts

Thumb pad

Green plunger rod

Finger grips

Grey syringe

plunger

Syringe body with medicine

Needle

Needle cap

GET READY

 

1a

Take the syringe from the refrigerator. Wait 30 minutes to let the syringe

 

warm to room temperature before you use it.

 

 

 

minutes

 

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 syringes

 

1c

 

Inspect the pre-filled syringe for damage to the

 

 

outside.

Do not uncap the syringe until you are ready to

 

 

inject. Check the label. Make sure the name Taltz

 

Expiration date

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

 

 

syringe, 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.

Back of

arm

Abdomen

Thigh

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.

INJECT

2a

Pull the needle cap off and throw it away.

 

DO NOT put the needle cap back on—you could

 

damage the needle or injure yourself by accident.

DO NOT touch the needle.

2b

Gently pinch and hold a fold of skin where you will

 

inject.

2cInsert the needle at a 45-degree

angle.

Then gently let go of your skin. Make sure to keep the needle in place.

2d

Green plunger rod

Grey syringe plunger

3 FINISH

3a

Push in the plunger.

Slowly push the plunger all the way in until all the medicine is injected. The grey syringe plunger should be pushed all the way to the end of the syringe. Gently remove the needle 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.

You should see the green plunger rod showing through the syringe body when the injection is complete.

Dispose of the pre-filled syringe.

DO NOT put the needle cap back on. Dispose of the syringe in a sharps container or as directed by your doctor, pharmacist or nurse.

When you dispose of syringes and the sharps container:

Dispose of the syringe 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 syringe, call your doctor, pharmacist or nurse.

If you have vision problems, DO NOT use the pre-filled syringe without help from a person trained to use it.

DO NOT share or reuse your Taltz pre-filled syringe. You may give or get an infection

Keep the syringe out of the reach and sight of children.

If you do not have a sharps container, ask your doctor, pharmacist or nurse about where you can get one.

Commonly asked questions

Q.What if I see air bubbles in my syringe?

A. It is normal to sometimes have air bubbles in the syringe. Taltz is injected under your 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 needle 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 cannot push in the plunger?

A.If the plunger is stuck or damaged:

DO NOT continue to use the syringe.

Remove the needle from your skin.

Q.How can I tell if my injection is complete?

A.When your injection is complete:

The green plunger rod should show through the body of the syringe.

The grey syringe plunger should be pushed all the way to the end of the syringe.

Read the full Instructions for Use and the Patient Information Leaflet for Taltz inside this box to learn more about your medicine.

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

Top

Needle

Bottom

1 GET READY

Injection button

Lock ring

Lock/unlock symbols

Medicine

Clear base

Twist-off base cap

1a Take the pre-filled pen from the refrigerator. 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

minutes

1c

Inspect the pre-filled pen. Check the label. Make sure

 

the name Taltz appears on the label.

Expiration date

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.

1eChoose your injection site.

Back of

arm

Abdomen

Thigh

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.

INJECT

2a

Make sure the lock ring is in the lock position.

DO NOT remove the base cap 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.

Thigh injection

2cKeep the base on your skin, and then turn the lock ring to the unlock position. You are now ready to inject.

2d

Click seconds

Grey plunger

3 FINISH

3a

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 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.

Dispose of the pre-filled pen.

DO NOT put the base cap back on. Dispose of the prefilled 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.

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.

Read the full Patient Information Leaflet for Taltz inside this box to learn more about your medicine.

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