Kevzara 200 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

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

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if these adverse reactions are not listed in this leaflet. See section 4.

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

Contents of this leaflet

1. What Kevzara is and what it is used for
2. What you need to know before using 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 moderate to severe active rheumatoid arthritis (RA) when previous treatment has not worked well or has not been tolerated. Kevzara may be used alone or in combination with a medicine called methotrexate.

It may help you by:

• slowing down joint damage
• improving your ability to carry out daily activities.

Kevzara is also used to treat adults with polymyalgia rheumatica after corticosteroids have been used but have not worked well, or if you experience a relapse while tapering the corticosteroid dose (gradual reduction). Kevzara may be used alone or together with a medicine called a corticosteroid.

How Kevzara works

• Kevzara binds to the receptor of another protein called interleukin-6 (IL-6) and blocks its action.
• IL-6 plays a key role in the symptoms of RA, such as pain, joint inflammation, morning stiffness, and fatigue.

2. What you need to know before using Kevzara

Do not use Kevzara:

• if you are allergic to sarilumab or to any of the other ingredients of this medicine (listed in section 6).
• if you have a serious active infection.

Warnings and precautions

Consult your doctor, pharmacist, or nurse if:

• you have any infection or if you get infections frequently. Kevzara may reduce your body's ability to fight infections: this means it may make you more susceptible to infections or may worsen an existing infection.
• you have tuberculosis (TB), symptoms of TB (persistent cough, weight loss, lack of appetite, low-grade fever), or have been in close contact with someone who has TB. Before starting treatment with Kevzara, your doctor will test you for TB.
• you have had viral hepatitis or any other liver disease. Before using Kevzara, your doctor will perform a blood test to check your liver function.
• you have had diverticulitis (a colon condition), or stomach or intestinal ulcers, or develop symptoms such as fever and persistent stomach pain (abdominal pain).
• you have ever had any type of cancer.
• you have recently been vaccinated or are scheduled to be vaccinated.

If any of the above apply to you (or if you are unsure), consult your doctor, pharmacist, or nurse before using Kevzara.

Blood tests should be performed before you receive Kevzara and periodically during treatment. These tests are to monitor for low blood cell counts, liver problems, or changes in your cholesterol levels.

Each time you receive a new pack of Kevzara, it is important to record the name of the medicine, the date of administration, and the batch number (shown on the packaging after "Lote") and keep this information in a safe place.

Children and adolescents

The Kevzara pre-filled syringe has not been studied in children aged 2 years and older with pJIA and is not indicated for use in children.

Kevzara is not recommended for use in children under 2 years of age. Kevzara should not be administered to children with pJIA weighing less than 10 kg.

Other medicines and Kevzara

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Kevzara may affect how other medicines work. Likewise, other medicines may affect how Kevzara works.

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

• a group of medicines called "Janus kinase (JAK) inhibitors" (used for conditions such as rheumatoid arthritis and cancer)
• other biological medicines used in the treatment of RA.

If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist.

Kevzara may affect how certain medicines work: this means that dose adjustments of other medicines may be necessary. If you are taking any of the following medicines, inform your doctor or pharmacist before using Kevzara:

• statins, used to lower cholesterol levels
• oral contraceptives
• theophylline, used to treat asthma
• warfarin, used to prevent blood clots.

If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist.

Pregnancy and breastfeeding

Talk to your doctor before using Kevzara if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant.

• Do not use Kevzara during pregnancy unless specifically recommended by your doctor.
• The effects of Kevzara on the unborn baby are unknown.
• Your doctor and you should decide whether you should receive Kevzara treatment while breastfeeding.

Driving and using machines

Kevzara is not expected to affect your ability to drive or operate machinery. However, if you feel tired or unwell after receiving Kevzara treatment, you should not drive or use machines.

KEVZARA contains polysorbate 20

This medicine contains 2.28 mg of polysorbate 20 in each 1.14 ml of injectable solution, equivalent to 2 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Kevzara

Treatment should be initiated by a physician experienced in the diagnosis and treatment of RA or polymyalgia rheumatica. Follow exactly the administration instructions for this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adult patients

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

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

Kevzara is administered as an injection under the skin (called a "subcutaneous" injection).

Learn how to use the pre-filled syringe

• Your doctor, pharmacist, or nurse will teach you how to inject Kevzara. Following these instructions, Kevzara may be injected by yourself or administered by a caregiver after receiving proper training.
• Carefully follow the "Instructions for Use" included in the package.
• 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, inform your doctor, pharmacist, or nurse.

If you forget to use a dose of Kevzara

If 3 days or fewer have passed since the missed dose:

• inject the missed dose as soon as possible.
• then administer your next dose on the next scheduled day.

If 4 days or more have passed, inject the next dose on the next scheduled day. Do not inject a double dose to make up for the missed injection.

If you are unsure when your next dose should be injected, ask your doctor, pharmacist, or nurse for instructions.

If you stop treatment with Kevzara

Do not stop treatment with Kevzara without discussing it with your doctor.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effect

Tell your doctor immediately if you think you have an infection (which may affect up to 1 in 10 people). Symptoms may include fever, sweating, or chills.

Other adverse effects

Tell your doctor, pharmacist, or nurse if you experience any of the following adverse effects:

Adults

Very common (may affect more than 1 in 10 people)

• Low white blood cell counts as shown in blood tests

Common (may affect up to 1 in 10 people)

• Infections of the sinuses or throat, nasal congestion or runny nose, and sore throat (upper respiratory tract infection)
• Urinary tract infection
• Cold sores (oral herpes)
• Low platelet counts as shown in blood tests
• High cholesterol, high triglycerides as shown in blood tests
• Abnormal liver function tests
• Injection site reactions (including redness and itching)
• Inflammation of the deep layers of the skin
• Lung infection

Uncommon (may affect up to 1 in 100 people)

• Diverticulitis (a condition affecting the intestine, often with stomach (abdominal) pain, nausea and vomiting, fever, and constipation, or less commonly diarrhea)

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

• Perforation of the stomach or intestines (a hole forming in the intestinal wall)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V*. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Kevzara

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and packaging following EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C).

• Do not freeze.
• Once removed from the refrigerator, do not store Kevzara at temperatures above 25 °C.
• Write the date you removed the syringe from the refrigerator in the space provided on the outer carton.
• Use the syringe within 14 days after removing it from the refrigerator or from the thermal bag.
• Keep the syringe in its original packaging to protect it from light.

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

After use, place the syringe in a sharps container. Always keep the container out of sight and reach of children. Ask your doctor, pharmacist, or nurse how to dispose of the container.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Kevzara

• The active substance is sarilumab. Each pre-filled syringe contains 150 mg or 200 mg of sarilumab in 1.14 ml of solution.
• The other components are arginine, histidine, polysorbate 20 (E 432), sucrose, and water for injections.

Appearance of the product and contents of the container

Kevzara is a clear, colourless to pale yellow injectable solution presented in a pre-filled syringe.

Each pre-filled syringe contains 1.14 ml of solution providing a single dose. Kevzara is available in packs containing 1 or 2 pre-filled syringes, and in multiple packs containing 3 packs, each with 2 pre-filled syringes.

Only certain pack sizes may be marketed.

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

Marketing Authorisation Holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer

Sanofi Winthrop Industrie

1051 Boulevard Industriel

76580 Le Trait,

France

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium Sanofi Belgium Tel/Tel: +32 (0)2 710 54 00	Lithuania Swixx Biopharma UAB Tel: +370 5 236 91 40
	Luxembourg/Luxembourg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgium/Belgium)
Czech Republic Sanofi s.r.o. Tel: +420 233 086 111	Hungary SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0050
Denmark Sanofi A/S Tlf: +45 45 16 70 00	Malta Sanofi S.r.l. +39. 02 39394275
Germany Sanofi-Aventis Deutschland GmbH Telephone: 0800 04 36 996 Telephone from abroad: +49 69 305 70 13	Netherlands Sanofi B.V. Tel: +31 20 245 4000
Estonia Swixx Biopharma OÜ Tel: +372 640 10 30	Norway sanofi-aventis Norge AS Tlf: +47 67 10 71 00
Greece Sanofi-Aventis Μονοπρóσωπη AEBE Tel: +30 210 900 16 00	Austria sanofi-aventis GmbH Tel: +43 1 80 185 – 0
Spain sanofi-aventis, S.A. Tel: +34 93 485 94 00	Poland Sanofi Sp. z o.o. Tel.: +48 22 280 00 00
France Sanofi Winthrop Industrie Tél: 0 800 222 555 Call from abroad: +33 1 57 63 23 23	Portugal Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400
Croatia Swixx Biopharma d.o.o. Tel: +385 1 2078 500	Romania Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00	Slovenia Swixx Biopharma d.o.o. Tel: +386 1 235 51 00
Iceland Vistor ehf. Telephone: +354 535 7000	Slovakia Swixx Biopharma s.r.o. Tel: +421 2 208 33 600
Italy Sanofi S.r.l. Tel: 800 536389	Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300
Cyprus C.A. Papaellinas Ltd. Tel: +357 22 741741	Sweden Sanofi AB Tel: +46 (0)8 634 50 00
Latvia Swixx Biopharma SIA Tel: +371 6 616 47 50

Date of the most recent review of this leaflet:

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

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Kevzara 200 mg solution for injection in pre-filled syringe

sarilumab

Instructions for use

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

Important information

This device is a single-dose pre-filled syringe (referred to as "syringe" in these instructions). It contains 200 mg of Kevzara for subcutaneous injection (injection under the skin) once every two weeks.

Ask your healthcare professional to show you how to use the syringe correctly before your first injection.

What you should do

• Read all instructions carefully before using a syringe.
• Check that you have the correct medicine and correct dose.
• Store unused syringes in the original carton and keep them in the refrigerator at a temperature between 2 °C and 8 °C.
• Store the carton in an insulated bag with a cold pack when travelling.
• Allow the syringe to reach room temperature for at least 30 minutes before use.
• Use the syringe within 14 days after removing it from the refrigerator or insulated bag.
• Keep the syringe out of sight and reach of children.

What you should not do

• Do not use the syringe if it is damaged or if the needle cap is missing or loose.
• Do not remove the needle cap until you are ready to inject.
• Do not touch the needle.
• Do not attempt to recap the syringe.
• Do not reuse the syringe.
• Do not freeze or heat the syringe.
• After removal from the refrigerator, do not store the syringe at temperatures above 25 °C.
• Do not expose the syringe to direct sunlight.
• Do not inject through clothing.

If you have any further questions, consult your doctor, pharmacist, or nurse.

Step A: Preparation for injection

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

   • You will need an alcohol swab, cotton ball or gauze, and a sharps container.
   • Remove one syringe from the carton by holding it in the middle of the barrel. Return any remaining syringes to the carton and store in the refrigerator.

2. Check the label.

   • Confirm that you have the correct medicine and correct dose.
   • Check the expiration date (EXP).

• Do not use the syringe if it is expired.

1. Inspect the medicine.
   • Check that the liquid is clear and colourless to pale yellow.
   • You may see an air bubble; this is normal.
   • Do not proceed with the injection if the liquid is cloudy, discoloured, or contains particles.

1. Place the syringe on a flat surface and allow it to reach 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 outside the refrigerator for more than 14 days.
   • Do not heat the syringe; allow it to warm naturally.
   • Do not expose the syringe to direct sunlight.

1. Select the injection site.
   • You may inject into your thigh or abdomen (except within 5 cm of your navel). If someone else is administering the injection, the outer upper arm may also be used.
   • Change the injection site each time you inject.
   • Do not inject into sensitive, damaged, bruised, or scarred skin.

1. Prepare the injection site.
   • Wash your hands.
   • Cleanse the skin with an alcohol swab.
   • Do not touch the injection site again before injecting.

Step B: Perform the injection – Proceed to Step B only after completing Step A “Preparation for injection”

1. Remove the needle cap.
   • Hold the syringe by the middle of the barrel, pointing the needle away from you.
   • Keep your hand off the plunger.
   • Do not remove air bubbles from the syringe.
   • Do not remove the cap until you are ready to inject.
   • Do not recap the needle.

1. Pinch the skin.
   • Use your thumb and index finger to pinch a skin fold at the injection site.

1. Insert the needle into the skin fold at an angle of approximately 45°.

1. Push the plunger down.
   • Slowly push the plunger until it stops and the syringe is empty.

1. Before removing the needle, check that the syringe is empty.
   • Remove the needle at the same angle used for insertion.
   • If you see blood, apply pressure to the injection site with a cotton ball or gauze.
   • Do not rub the skin after the injection.

1. Immediately place the used syringe and needle cap into a sharps container.
   • Always keep the container out of sight and reach of children.
   • Do not recap the needle.
   • Do not throw the used syringe into household waste.
   • Do not dispose of the used sharps container in household waste unless permitted by local regulations. Ask your doctor, pharmacist, or nurse how to dispose of the container properly.