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Kevzara (sarilumab) – Package leaflet - L04AC14

Updated on site: 08-Oct-2017

Medication nameKevzara
ATC CodeL04AC14
Substancesarilumab
Manufacturersanofi-aventis groupe

Package leaflet: Information for the patient

Kevzara 150 mg solution for injection in pre-filled syringe

Kevzara 200 mg solution for injection in pre-filled syringe

Sarilumab

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.

In addition to this leaflet, you will be given a patient alert card, which contains important safety information that you need before and during treatment with Kevzara.

What is in this leaflet

1.What Kevzara is and what it is used for

2.What you need to know before you use Kevzara

3.How to use Kevzara

4.Possible side effects

5.How to store Kevzara

6.Contents of the pack and other information

1.What Kevzara is and what it is used for

What Kevzara is

Kevzara contains the active substance sarilumab. It is a type of protein called a monoclonal antibody.

What Kevzara is used for

Kevzara is used to treat adults with moderately to severely active rheumatoid arthritis if previous therapy did not work well enough or was not tolerated. Kevzara can be used alone or together with a medicine called methotrexate.

It may help you by:

slowing down damage to joints

improving your ability to perform daily activities.

How Kevzara works

Kevzara attaches to another protein called interleukin-6 (IL-6) receptor and blocks its action.

IL-6 plays a major role in the symptoms of rheumatoid arthritis such as pain, swollen joints, morning stiffness, and fatigue.

2.What you need to know before you use Kevzara

Do not use Kevzara:

if you are allergic to sarilumab or any of the other ingredients of this medicine (listed in section 6).

if you have an active severe infection.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse if:

you have any infection or you get a lot of infections. Kevzara can lower your body's ability to fight infection: this means it can make you more likely to get infections or make your infection worse.

you have tuberculosis (TB), symptoms of TB (persistent cough, weight loss, listlessness, mild fever), or have been in close contact with someone with TB. Before you are given Kevzara, your doctor will check you for TB.

you have had viral hepatitis or other liver disease. Before you use Kevzara, your doctor will do a blood test to check your liver function.

you have had diverticulitis (a condition of the lower bowel) or ulcers in your stomach or intestines, or develop symptoms such as fever and stomach (abdominal) pain that does not go away.

you have ever had any type of cancer.

you have recently had any vaccination or are going to have vaccination.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Kevzara.

You will have blood tests before you are given Kevzara. You will also have the tests during your treatment. This is to check for low blood cell count, liver problems, or changes in your cholesterol levels.

Children and adolescents

Kevzara is not recommended in children and adolescents under 18 years of age.

Other medicines and Kevzara

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.. This is because Kevzara can affect the way some other medicines work. Also some other medicines can affect the way Kevzara works.

In particular, do not use Kevzara and tell your doctor or pharmacist if you are using:

a group of medicines called “Janus kinase (JAK) inhibitors” (used for diseases like rheumatoid arthritis and cancer)

other biological medicines used in the treatment of rheumatoid arthritis

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist.

Kevzara can affect the way some medicines work: this means the dose of other medicines may need changing. If you are using any of the following medicines, tell your doctor or pharmacist before using Kevzara:

statins, used to reduce cholesterol level

oral contraceptives

theophylline, used to treat asthma

warfarin, used to prevent blood clots.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist.

Pregnancy and breast-feeding

Talk to your doctor before using Kevzara if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

Do not take Kevzara if you are pregnant unless your doctor specifically recommends it.

The effects of Kevzara on an unborn baby are not known.

You and your doctor should decide if you should use Kevzara if you are breast-feeding.

Driving and using machines

The use of Kevzara is not expected to affect your ability to drive or use machines. However, if you are feeling tired or unwell after you use Kevzara, you should not drive or use machines.

3.How to use Kevzara

Treatment should be started by a doctor experienced in the diagnosis and treatment of rheumatoid arthritis. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Kevzara is given as an injection under the skin (called subcutaneous injection).

The recommended dose is one 200 mg injection every two weeks.

Your doctor may adjust the dose of your medicine based on results of blood tests.

Learning how to use the pre-filled syringe

Your doctor, pharmacist, or nurse will show you how to inject Kevzara. Following these instructions, Kevzara can be self-injected or administered by a care-giver.

Carefully follow the “Instructions for Use” provided in the carton.

Use the pre-filled syringe exactly as described in the “Instructions for Use”.

If you use more Kevzara than you should

If you have used more Kevzara than you should, talk to your doctor, pharmacist or nurse.

If you miss a dose of Kevzara

If it has been 3 days or less since the missed dose:

inject your missed dose as soon as you can.

then inject your next dose at your regular time.

If it has been 4 days or more, inject the next dose at your regular time. Do not inject a double dose to make up for a forgotten injection.

If you are unsure when to inject your next dose ask your doctor, pharmacist or nurse for instructions.

If you stop using Kevzara

Do not stop using Kevzara without talking to your doctor.

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 effect

Tell your doctor straight away if you think you have an infection (which may affect up to 1 in every 10 people). The symptoms may include fever, sweats, or chills.

Other side effects

Tell your doctor, pharmacist, or nurse if you notice any of the following side effects: Very Common (may affect more than 1 in 10 people):

Low white blood cell counts shown by blood tests

Common (may affect up to 1 in 10 people):

infections in your sinuses or throat, blocked or runny nose and sore throat (upper respiratory tract infection)

urinary tract infection

cold sores (oral herpes)

low platelet counts shown by blood tests

high cholesterol, high triglycerides shown by blood tests

abnormal liver function tests

injection-site reactions (including redness and itching).

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 Kevzara

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 label 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 or heat the syringe.

Once taken out of the refrigerator, do not store Kevzara above 25 ºC.

Write down the date of removal from the refrigerator in the space provided on the outer carton.

Use the syringe within 14 days after taking it out of the refrigerator or the insulated bag.

Keep the syringe in the original carton in order to protect it from light.

Do not use this medicine if the solution in the syringe is cloudy, discoloured or contains particles, or if any part of the pre-filled syringe looks damaged.

After use, put the syringe into a puncture-resistant container. Always keep the container out of the sight and reach of children. Ask your doctor, pharmacist, or nurse how to throw away the container. Do not recycle the container.

Do not throw away any medicines via wastewater or household waste. Ask your 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 Kevzara contains

The active substance is sarilumab.

The other ingredients are arginine, histidine, polysorbate 20, sucrose, and water for injections.

What Kevzara looks like and contents of the pack

Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled syringe.

Each pre-filled syringe contains 1.14 ml of solution delivering one single dose. It is available in a pack size of 2 or a multipack of 6 pre-filled syringes (3 packs of 2).

Not all pack sizes may be marketed.

Kevzara is available as 150 mg or 200 mg pre-filled syringes.

Marketing Authorisation Holder sanofi-aventis groupe

54, rue La Boétie F-75008 Paris France

Manufacturer

Sanofi Winthrop Industrie

1051 Boulevard Industriel

76580 Le Trait,

France

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

België/Belgique/Belgien

Lietuva

Sanofi Belgium

UAB "SANOFI-AVENTIS LIETUVA"

Tél/Tel: +32 (0)2 710 54 00

Tel: +370 5 2755224

България

Luxembourg/Luxemburg

SANOFI BULGARIA EOOD

Sanofi Belgium

Тел.: +359 (0)2 970 53 00

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika

Magyarország

sanofi-aventis, s.r.o.

SANOFI-AVENTIS Zrt.

Tel: +420 233 086 111

Tel.: +36 1 505 0050

Danmark

Malta

sanofi-aventis Denmark A/S

Sanofi Malta Ltd.

Tlf: +45 45 16 70 00

Tel: +356 21493022

Deutschland

Nederland

Sanofi-Aventis Deutschland GmbH

sanofi-aventis Netherlands B.V.

Tel: +49 (0)180 2 222010

Tel: +31 (0)182 557 755

Eesti

Norge

sanofi-aventis Estonia OÜ

sanofi-aventis Norge AS

Tel: +372 627 34 88

Tlf: +47 67 10 71 00

Ελλάδα

Österreich

sanofi-aventis AEBE

sanofi-aventis GmbH

Τηλ: +30 210 900 16 00

Tel: +43 1 80 185 – 0

España

Polska

sanofi-aventis, S.A.

sanofi-aventis Sp. z o.o.

Tel: +34 93 485 94 00

Tel.: +48 22 280 00 00

France

Portugal

sanofi-aventis france

Sanofi - Produtos Farmacêuticos, Lda

Tél: 0 800 222 555

Tel: +351 21 35 89 400

Appel depuis l’étranger : +33 1 57 63 23 23

 

Hrvatska

România

sanofi-aventis Croatia d.o.o.

Sanofi Romania SRL

Tel: +385 1 600 34 00

Tel: +40 (0) 21 317 31 36

 

Ireland

Slovenija

sanofi-aventis Ireland Ltd. T/A SANOFI

sanofi-aventis d.o.o.

Tel: +353 (0) 1 403 56 00

Tel: +386 1 560 48 00

Ísland

Slovenská republika

Vistor hf.

sanofi-aventis Pharma Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 2 33 100 100

Italia

Suomi/Finland

Sanofi S.p.A.

Sanofi Oy

Tel: 800 13 12 12 (domande di tipo tecnico)

Puh/Tel: +358 (0) 201 200 300

800 536389 (altre domande)

 

Κύπρος

Sverige

sanofi-aventis Cyprus Ltd.

Sanofi AB

Τηλ: +357 22 871600

Tel: +46 (0)8 634 50 00

Latvija

United Kingdom

sanofi-aventis Latvia SIA

Sanofi

Tel: +371 67 33 24 51

Tel: +44 (0) 845 372 7101

This leaflet was last revised in .

 

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

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Kevzara 150 mg solution for injection in a pre-filled syringe sarilumab

Instructions for use

The parts of the Kevzara pre-filled syringe are shown in this picture.

Important information

This device is a single-dose pre-filled syringe (called “syringe” in these instructions). It contains

150 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.

Ask your healthcare professional to show you the right way to use the syringe before your first injection.

Do

Read all of the instructions carefully before using a syringe.

Check that you have the correct medicine and the correct dose.

Keep unused syringes in the original carton and store in the refrigerator between 2ºC and 8ºC.

Keep the carton in an insulated bag with an ice pack when travelling.

Let the syringe warm up to room temperature for at least 30 minutes before using.

Use the syringe within 14 days after taking it out of the refrigerator or insulated bag.

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

Do not

Do not use the syringe if it has been damaged or the needle cap is missing or not attached.

Do not remove the needle cap until just before you are ready to inject.

Do not touch the needle.

Do not try to put the cap back on the syringe.

Do not re-use the syringe.

Do not freeze or heat the syringe.

Once removed from the refrigerator, do not store the syringe above 25ºC.

Do not expose the syringe to direct sunlight. Do not inject through your clothes.

If you have any further questions, ask your doctor, pharmacist or nurse or call the sanofi number on the package leaflet.

Step A: Get ready for an injection

1.Prepare all the equipment you will need on a clean, flat working surface.

You will need an alcohol wipe, a cotton ball or gauze, and a puncture-resistant container.

Take one syringe out of the packaging by holding the middle of the syringe body. Keep the remaining syringe in the carton in the refrigerator.

2.Look at the label.

Check that you have the correct medicine and the correct dose.

Check the expiry date (EXP).

Do not use the syringe if the date has passed.

3.Look at the medicine.

Check that the liquid is clear and colourless to pale yellow.

You may see an air bubble, this is normal.

Do not inject if the liquid is cloudy, discoloured or contains particles.

4. Lay the syringe on a flat surface and allow it to warm up to room temperature (<25°C) for at least 30 minutes.

Using the syringe at room temperature may make the injection more comfortable. Do not use the syringe if it has been out of the refrigerator for more than 14 days. Do not heat the syringe; let it warm up on its own.

Do not expose the syringe to direct sunlight.

5.Select the injection site.

You can inject into your thigh or belly (abdomen) except for the 5 cm around your belly button (navel). If somebody else gives you the injection, you can also use the outer area of the upper arm.

Change injection site each time you inject.

Do not inject into skin that is tender, damaged or has bruises or scars.

6.Prepare the injection site.

Wash your hands.

Clean skin with an alcohol wipe.

Do not touch the injection site again before the injection.

Step B: Perform the injection – Perform Step B only after completing Step A “Get ready for an injection”

1.Pull off the needle cap.

Hold the syringe in the middle of the syringe body with the needle pointing away from you.

Keep your hand away from the plunger.

Do not get rid of any air bubbles in the syringe.

Do not pull off the needle cap until you are ready to inject.

Do not put the needle cap back on.

2.Pinch the skin.

Use your thumb and first (index) finger to pinch a fold of skin at the injection site.

3. Insert the needle into the fold of skin at roughly a 45º angle.

4.Push the plunger down.

Slowly push the plunger down as far as it will go until the syringe is empty.

5.Before you remove the needle, check that the syringe is empty.

Pull the needle out at the same angle it was injected.

If you see any blood, press a cotton ball or gauze on the site.

Do not rub your skin after the injection.

6. Put your used syringe and the cap into a puncture-resistant container right away after use.

Always keep the container out of the sight and reach of children. Do not put the needle cap back on.

Do not throw the used syringe in household waste.

Do not recycle your used puncture-resistant container.

Do not dispose of your used puncture-resistant container in your household waste unless your local guidelines permit this. Ask your doctor, pharmacist or nurse how to throw away the container.

Kevzara 200 mg solution for injection in a pre-filled syringe sarilumab

Instructions for use

The parts of the Kevzara pre-filled syringe are shown in this picture.

Important information

This device is a single-dose pre-filled syringe (called “syringe” in these instructions). It contains

200 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.

Ask your healthcare professional to show you the right way to use the syringe before your first injection.

Do

Read all of the instructions carefully before using a syringe.

Check that you have the correct medicine and the correct dose.

Keep unused syringes in the original carton and store in the refrigerator between 2ºC and 8ºC.

Keep the carton in an insulated bag with an ice pack when travelling.

Let the syringe warm up to room temperature for at least 30 minutes before using.

Use the syringe within 14 days after taking it out of the refrigerator or insulated bag.

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

Do not

Do not use the syringe if it has been damaged or the needle cap is missing or not attached.

Do not remove the needle cap until just before you are ready to inject.

Do not touch the needle.

Do not try to put the cap back on the syringe.

Do not re-use the syringe.

Do not freeze or heat the syringe.

Once removed from the refrigerator, do not store the syringe above 25ºC.

Do not expose the syringe to direct sunlight. Do not inject through your clothes.

If you have any further questions, ask your doctor, pharmacist or nurse or call the sanofi number on the package leaflet.

Step A: Get ready for an injection

1. Prepare all the equipment you will need on a clean, flat working surface.

You will need an alcohol wipe, a cotton ball or gauze, and a puncture-resistant container.

Take one syringe out of the packaging by holding the middle of the syringe body. Keep the remaining syringe in the carton in the refrigerator.

2. Look at the label.

Check that you have the correct medicine and the correct dose.

Check the expiry date (EXP).

Do not use the syringe if the date has passed.

3. Look at the medicine.

Check that the liquid is clear and colourless to pale yellow.

You may see an air bubble, this is normal.

Do not inject if the liquid is cloudy, discoloured or contains particles.

4. Lay the syringe on a flat surface and allow it to warm up to room temperature (<25°C) for at least 30 minutes.

Using the syringe at room temperature may make the injection more comfortable. Do not use the syringe if it has been out of the refrigerator for more than 14 days. Do not heat the syringe; let it warm up on its own.

Do not expose the syringe to direct sunlight.

5. Select the injection site.

You can inject into your thigh or belly (abdomen) except for the 5 cm around your belly button (navel). If somebody else gives you the injection, you can also use the outer area of the upper arm.

Change injection site each time you inject.

Do not inject into skin that is tender, damaged or has bruises or scars.

6. Prepare the injection site.

Wash your hands.

Clean skin with an alcohol wipe.

Do not touch the injection site again before the injection.

Step B: Perform the injection – Perform Step B only after completing Step A “Get ready for an injection”

1. Pull off the needle cap.

Hold the syringe in the middle of the syringe body with the needle pointing away from you.

Keep your hand away from the plunger.

Do not get rid of any air bubbles in the syringe.

Do not pull off the needle cap until you are ready to inject. Do not put the needle cap back on.

2. Pinch the skin.

Use your thumb and first (index) finger to pinch a fold of skin at the injection site.

3. Insert the needle into the fold of skin at roughly a 45º angle.

4. Push the plunger down.

Slowly push the plunger down as far as it will go until the syringe is empty.

5. Before you remove the needle, check that the syringe is empty.

Pull the needle out at the same angle it was injected.

If you see any blood, press a cotton ball or gauze on the site.

Do not rub your skin after the injection.

6. Put your used syringe and the cap into a puncture-resistant container right away after use.

Always keep the container out of the sight and reach of children. Do not put the needle cap back on.

Do not throw the used syringe in household waste.

Do not recycle your used puncture-resistant container.

Do not dispose of your used puncture-resistant container in your household waste unless your local guidelines permit this. Ask your doctor, pharmacist or nurse how to throw away the container.

Package leaflet: Information for the patient

Kevzara 150 mg solution for injection in pre-filled pen

Kevzara 200 mg solution for injection in pre-filled pen

Sarilumab

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.

In addition to this leaflet, you will be given a patient alert card, which contains important safety information that you need before and during treatment with Kevzara.

What is in this leaflet

1.What Kevzara is and what it is used for

2.What you need to know before you use Kevzara

3.How to use Kevzara

4.Possible side effects

5.How to store Kevzara

6.Contents of the pack and other information

1. What Kevzara is and what it is used for

What Kevzara is

Kevzara contains the active substance sarilumab. It is a type of protein - called a “monoclonal antibody”.

What Kevzara is used for

Kevzara is used to treat adults with moderately to severely active rheumatoid arthritis if previous therapy did not work well enough or was not tolerated. Kevzara can be used alone or together with a medicine called methotrexate.

It may help you by:

slowing down damage to joints

improving your ability to perform daily activities.

How Kevzara works

Kevzara attaches to another protein called interleukin-6 (IL-6) receptor and blocks its action.

IL-6 plays a major role in the symptoms of rheumatoid arthritis such as pain, swollen joints, morning stiffness, and fatigue.

2. What you need to know before you use Kevzara

Do not use Kevzara:

if you are allergic to sarilumab or any of the other ingredients of this medicine (listed in section 6).

if you have an active severe infection.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse if:

you have any infection or, you get a lot of infections. Kevzara can lower your body's ability to fight infection and this means it can make you more likely to get infections or make your infection worse.

you have tuberculosis (TB), symptoms of TB (persistent cough, weight loss, listlessness, mild fever), or have been in close contact with someone with TB. Before you are given Kevzara, your doctor will check you for TB.

you have had viral hepatitis or other liver disease. Before you use Kevzara, your doctor will do a blood test to check your liver function.

you have had diverticulitis (a condition of the lower bowel) or ulcers in your stomach or intestines, or develop symptoms such as fever and stomach (abdominal) pain that does not go away.

you have ever had any type of cancer.

you have recently had or any vaccination or are going to have vaccination.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Kevzara.

You will have blood tests before you are given Kevzara. You will also have the tests during your treatment. This is to check if you have a low blood cell count, liver problems, or changes in your cholesterol levels.

Children and adolescents

Kevzara is not recommended in children and adolescents under 18 years of age.

Other medicines and Kevzara

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is because Kevzara can affect the way some other medicines work, Also some other medicines can affect the way Kevzara works.

In particular, do not use Kevzara and tell your doctor or pharmacist if you are using:

a group of medicines called “Janus kinase (JAK) inhibitors” (used for disease like rheumatoid arthritis and cancer)

other biological medicines used in the treatment of rheumatoid arthritis.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist.

Kevzara can affect the way some medicines workthis means the dose of other medicines may need changing. If you are using any of the following medicines, tell your doctor or pharmacist before using Kevzara:

statins, used to reduce cholesterol level

oral contraceptives

theophylline, used to treat asthma

warfarin, used to prevent blood clots

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist.

Pregnancy and breast-feeding

Talk to your doctor before using Kevzara if you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby.

Do not take Kevzara if you are pregnant – unless your doctor specifically recommends it.

The effects of Kevzara on an unborn baby are not known.

You and your doctor should decide if you should use Kevzara if you are breast-feeding.

Driving and using machines

The use of Kevzara is not expected to affect your ability to drive or use machines. However, if you are feeling tired or unwell after you use Kevzara, you should not drive or use machines.

3. How to use Kevzara

Treatment should be started by a doctor experienced in the diagnosis and treatment of rheumatoid arthritis. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Kevzara is given as an injection under the skin (called “subcutaneous ” injection).

The recommended dose is one 200 mg injection every two weeks.

Your doctor may adjust the dose of your medicine based on results of blood tests.

Learning how to use the pre-filled pen

Your doctor, pharmacist, or nurse will show you how to inject Kevzara. Following these instructions Kevzara can be self-injected or administered by a care-giver.

Carefully follow the “Instructions for Use” provided in the carton.

Use the pre-filled pen exactly as described in the “Instructions for Use”.

If you use more Kevzara than you should

If you have used more Kevzara than you should, talk to your doctor, pharmacist or nurse.

If you miss a dose of Kevzara

If it has been 3 days or less since the missed dose :

inject your missed dose as soon as you can.

then inject your next dose at your regular time.

If it has been 4 days or more, inject the next dose at your regular time. Do not inject a double dose to make up for a forgotten injection.

If you are unsure when to inject your next dose : ask your doctor, pharmacist or nurse for instructions.

If you stop using Kevzara

Do not stop using Kevzara without talking to your doctor.

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 effect

Tell your doctor straight away if you think you have an infection(which may affect upto 1 in every 10 people). The symptoms may include fever, sweats, or chills.

Other side effects

Tell your doctor, pharmacist, or nurse if you notice any of the following side effects: Very Common (may affect more than 1 in 10 people):

Low white blood cell counts shown by blood tests

Common (may affect up to 1 in 10 people):

infections in your sinuses or throat, blocked or runny nose and sore throat (“upper respiratory tract infection”)

urinary tract infection

cold sores (“oral herpes”)

low platelet counts shown by blood tests

high cholesterol, high triglycerides shown by blood tests

abnormal liver function tests

injection site reactions (including redness and itching)

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 Kevzara

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 label 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 or heat the pen.

Once taken out the refrigerator, do not store Kevzara above 25 ºC.

Write down the date of removal from the refrigerator in the space provided on the outer carton.

Use the pen within 14 days after taking it out of the refrigerator or the insulated bag.

Keep the pen in the original carton in order to protect it from light.

Do not use this medicine if the solution in the pen is cloudy, discoloured or contains particles, or if any part of the pre-filled pen looks damaged.

After use, put the pen into a puncture-resistant container. Always keep the container out of the sight and reach of children. Ask your doctor, pharmacist, or nurse how to throw away the container. Do not recycle the container.

Do not throw away any medicines via wastewater or household waste. Ask your 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 Kevzara contains

The active substance is sarilumab.

The other ingredients are arginine, histidine, polysorbate 20, sucrose, and water for injections.

What Kevzara looks like and contents of the pack

Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled pen.

Each pre-filled pen contains 1.14 ml of solution delivering one single dose. It is available in a pack size of 2 or a multipack of 6 pre-filled pens (3 packs of 2).

Not all pack sizes may be marketed.

Kevzara is available as 150 mg or 200 mg pre-filled pens.

Marketing Authorisation Holder sanofi-aventis groupe

54, rue La Boétie F-75008 Paris France

Manufacturer

Sanofi-Aventis Deutschland GmbH Brüningstraße 50

Industriepark Höchst 65926 Frankfurt am Main Germany

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

België/Belgique/Belgien

Lietuva

Sanofi Belgium

UAB "SANOFI-AVENTIS LIETUVA"

Tél/Tel: +32 (0)2 710 54 00

Tel: +370 5 2755224

България

Luxembourg/Luxemburg

SANOFI BULGARIA EOOD

Sanofi Belgium

Тел.: +359 (0)2 970 53 00

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika

Magyarország

sanofi-aventis, s.r.o.

SANOFI-AVENTIS Zrt.

Tel: +420 233 086 111

Tel.: +36 1 505 0050

Danmark

Malta

sanofi-aventis Denmark A/S

Sanofi Malta Ltd.

Tlf: +45 45 16 70 00

Tel: +356 21493022

Deutschland

Nederland

Sanofi-Aventis Deutschland GmbH

sanofi-aventis Netherlands B.V.

Tel: +49 (0)180 2 222010

Tel: +31 (0)182 557 755

Eesti

Norge

sanofi-aventis Estonia OÜ

sanofi-aventis Norge AS

Tel: +372 627 34 88

Tlf: +47 67 10 71 00

Ελλάδα

Österreich

sanofi-aventis AEBE

sanofi-aventis GmbH

Τηλ: +30 210 900 16 00

Tel: +43 1 80 185 – 0

España

Polska

sanofi-aventis, S.A.

sanofi-aventis Sp. z o.o.

Tel: +34 93 485 94 00

Tel.: +48 22 280 00 00

France

Portugal

sanofi-aventis france

Sanofi - Produtos Farmacêuticos, Lda

Tél: 0 800 222 555

Tel: +351 21 35 89 400

Appel depuis l’étranger : +33 1 57 63 23 23

 

 

Hrvatska

România

sanofi-aventis Croatia d.o.o.

Sanofi Romania SRL

Tel: +385 1 600 34 00

Tel: +40 (0) 21 317 31 36

Ireland

Slovenija

sanofi-aventis Ireland Ltd. T/A SANOFI

sanofi-aventis d.o.o.

Tel: +353 (0) 1 403 56 00

Tel: +386 1 560 48 00

Ísland

Slovenská republika

Vistor hf.

sanofi-aventis Pharma Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 2 33 100 100

Italia

Suomi/Finland

Sanofi S.p.A.

Sanofi Oy

Tel: 800 13 12 12 (domande di tipo tecnico)

Puh/Tel: +358 (0) 201 200 300

800 536389 (altre domande)

 

Κύπρος

Sverige

sanofi-aventis Cyprus Ltd.

Sanofi AB

Τηλ: +357 22 871600

Tel: +46 (0)8 634 50 00

Latvija

United Kingdom

sanofi-aventis Latvia SIA

Sanofi

Tel: +371 67 33 24 51

Tel: +44 (0) 845 372 7101

This leaflet was last revised in

 

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

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

Kevzara 150 mg solution for injection in a pre-filled pen sarilumab

Instructions for use

The parts of the Kevzara pre-filled pen are shown in this picture.

Important information

This device is a single-dose pre-filled pen (called “pen” in these instructions). It contains 150 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.

Ask your healthcare professional to show you the right way to use the pen before your first injection.

Do

Read all of the instructions carefully before using a pen.

Check that you have the correct medicine and the correct dose.

Keep unused pens in the original carton and store in the refrigerator between 2ºC and 8ºC.

Keep the carton in an insulated bag with an ice pack when travelling.

Let the pen warm up to room temperature for at least 60 minutes before using.

Use the pen within 14 days after taking it out of the refrigerator or insulated bag.

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

Do not

Do not use a pen if it has been damaged or the cap is missing or not attached. Do not remove the cap until just before you are ready to inject.

Do not press or touch the yellow needle cover with your fingers.

Do not try to put the cap back on a pen.

Do not re-use the pen.

Do not freeze or heat the pen.

Once removed from the refrigerator, do not store the pen above 25ºC.

Do not expose the pen to direct sunlight.

Do not inject through your clothes.

If you have any further questions, ask your doctor, pharmacist or nurse or call the sanofi number on the package leaflet.

Step A: Get ready for an injection

1. Prepare all the equipment you will need on a clean, flat working surface.

You will need an alcohol wipe, a cotton ball or gauze, and a puncture-resistant container.

Take one pen out of the packaging by holding the middle of the pen body. Keep the remaining pen in the carton in the refrigerator.

2. Look at the label.

Check that you have the correct medicine and the correct dose.

Check the expiry date (EXP), this is shown on the side of the pens.

Do not use the pen if the date has passed.

3.Look at the window.

Check that the liquid is clear and colourless to pale yellow.

You may see an air bubble, this is normal.

Do not inject if the liquid is cloudy, discoloured or contains particles.

Do not use if the window is solid yellow.

4. Lay the pen on a flat surface and allow it to warm up to room temperature (<25°C) for at least 60 minutes.

Using the pen at room temperature may make the injection more comfortable. Do not use the pen if it has been out of the refrigerator for more than 14 days. Do not heat the pen; let it warm up on its own.

Do not expose the pen to direct sunlight.

5. Select the injection site.

You can inject into your thigh or belly (abdomen) except for the 5 cm around your belly button (navel). If somebody else gives you the injection, you can also use the outer area of the upper arm.

Change injection site each time you inject.

Do not inject into skin that is tender, damaged or has bruises or scars.

6. Prepare the injection site.

Wash your hands.

Clean skin with an alcohol wipe.

Do not touch the injection site again before the injection.

Step B: Perform the injection – Perform Step B only after completing Step A “Get ready for an injection”

1. Twist or pull off the orange cap.

Do not remove the cap until you are ready to inject.

Do not press or touch the yellow needle cover with your fingers.

Do not put the cap back on.

2.Put the yellow needle cover on your skin at roughly a 90° angle.

Make sure you can see the window.

3.Press down and hold the pen firmly against your skin.

There will be a “click” when the injection starts.

4.Keep holding the pen firmly against your skin.

The window will start to turn yellow.

The injection can take up to 15 seconds.

5. There will be a second click. Check to see if the entire window has turned yellow before you remove the pen.

If you do not hear the second click, you should still check to see if the window has turned fully yellow.

If the window does not turn fully yellow, do not give yourself a second dose without speaking to your healthcare provider.

6. Pull the pen away from your skin.

If you see any blood, press a cotton ball or gauze on the site. Do not rub your skin after the injection.

7. Put your used pen and the cap into a puncture-resistant container right away after use.

Always keep the container out of the sight and reach of children. Do not put the cap back on.

Do not throw the used pens in household waste.

Do not recycle your used puncture-resistant container.

Do not dispose of your used puncture-resistant container in your household waste unless your local guidelines permit this. Ask your doctor, pharmacist or nurse how to throw away the container.

Kevzara 200 mg solution for injection in a pre-filled pen sarilumab

Instructions for use

The parts of the Kevzara pre-filled pen are shown in this picture.

Important information

This device is a single-dose pre-filled pen (called “pen” in these instructions). It contains 200 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.

Ask your healthcare professional to show you the right way to use the pen before your first injection.

Do

Read all of the instructions carefully before using a pen.

Check that you have the correct medicine and the correct dose.

Keep unused pens in the original carton and store in the refrigerator between 2ºC and 8ºC.

Keep the carton in an insulated bag with an ice pack when travelling.

Let the pen warm up to room temperature for at least 60 minutes before using.

Use the pen within 14 days after taking it out of the refrigerator or insulated bag.

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

Do not

Do not use a pen if it has been damaged or the cap is missing or not attached.

Do not remove the cap until just before you are ready to inject.

Do not press or touch the yellow needle cover with your fingers.

Do not try to put the cap back on a pen.

Do not re-use the pen.

Do not freeze or heat the pen.

Once removed from the refrigerator, do not store the pen above 25ºC.

Do not expose the pen to direct sunlight.

Do not inject through your clothes.

If you have any further questions, ask your doctor, pharmacist or nurse or call the sanofi number on the package leaflet.

Step A: Get ready for an injection

1. Prepare all the equipment you will need on a clean, flat working surface.

You will need an alcohol wipe, a cotton ball or gauze, and a puncture-resistant container.

Take one pen out of the packaging by holding the middle of the pen body. Keep the remaining pen in the carton in the refrigerator.

2. Look at the label.

Check that you have the correct medicine and the correct dose.

Check the expiry date (EXP), this is shown on the side of the pens.

Do not use the pen if the date has passed.

3. Look at the window.

Check that the liquid is clear and colourless to pale yellow.

You may see an air bubble, this is normal.

Do not inject if the liquid is cloudy, discoloured or contains particles.

Do not use if the window is solid yellow.

4. Lay the pen on a flat surface and allow it to warm up to room temperature (<25°C) for at least

60minutes.

Using the pen at room temperature may make the injection more comfortable.

Do not use the pen if it has been out of the refrigerator for more than 14 days.

Do not heat the pen; let it warm up on its own. Do not expose the pen to direct sunlight.

5. Select the injection site.

You can inject into your thigh or belly (abdomen) except for the 5 cm around your belly button (navel). If somebody else gives you the injection, you can also use the outer area of the upper arm.

Change injection site each time you inject.

Do not inject into skin that is tender, damaged or has bruises or scars.

6. Prepare the injection site.

Wash your hands.

Clean skin with an alcohol wipe.

Do not touch the injection site again before the injection.

Step B: Perform the injection – Perform Step B only after completing Step A “Get ready for an injection”

1. Twist or pull off the orange cap.

Do not remove the cap until you are ready to inject.

Do not press or touch the yellow needle cover with your fingers.

Do not put the cap back on.

2. Put the yellow needle cover on your skin at roughly a 90° angle.

Make sure you can see the window.

3. Press down and hold the pen firmly against your skin.

There will be a “click” when the injection starts.

4. Keep holding the pen firmly against your skin.

The window will start to turn yellow.

The injection can take up to 15 seconds.

5. There will be a second click. Check to see if the entire window has turned yellow before you remove the pen.

If you do not hear the second click, you should still check to see if the window has turned fully yellow.

If the window does not turn fully yellow, do not give yourself a second dose without speaking to your healthcare provider.

6. Pull the pen away from your skin.

If you see any blood, press a cotton ball or gauze on the site. Do not rub your skin after the injection.

7. Put your used pen and the cap into a puncture-resistant container right away after use.

Always keep the container out of the sight and reach of children. Do not put the cap back on.

Do not throw the used pens in household waste.

Do not recycle your used puncture-resistant container.

Do not dispose of your used puncture-resistant container in your household waste unless your local guidelines permit this. Ask your doctor, pharmacist or nurse how to throw away the container.

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