KEVZARA 200 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

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 a severe active infection.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse if:

• you have any infection or if you get infections often. Kevzara may reduce your body's ability to fight infection: this means you may be more likely to get infections or make your infection worse.
• you have tuberculosis (TB), symptoms of TB (persistent cough, weight loss, lack of interest, mild fever), or have been in close contact with someone with TB. Before starting treatment with Kevzara, your doctor will perform TB tests.
• you have had viral hepatitis or other liver disease. Before using Kevzara, your doctor will perform a blood test to check your liver function.
• you have had diverticulitis (a disease of the colon) or stomach or intestinal ulcers, or develop symptoms such as fever and stomach pain (abdominal pain) that does not go away.
• you have ever had any type of cancer.
• you have been vaccinated recently or are going to be vaccinated.

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

Blood tests should be performed before you receive Kevzara. Blood tests should also be performed during your treatment. This is to check if you have a low blood cell count, liver problems, or changes in your cholesterol levels.

Each time you receive a new pack of Kevzara, it is important that you write down the name of the medicine, the date of administration, and the batch number (which appears on the pack after “Batch”) and keep this information in a safe place.

Children and adolescents

The Kevzara pre-filled syringe has not been studied in children from 2 years of age 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 who weigh less than 10 kg.

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 may affect the way other medicines work. Other medicines may also 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 inhibitors (JAK)” (used for diseases such as rheumatoid arthritis and cancer)
• other biologic medicines used to treat RA.

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

Kevzara may affect the way some medicines work: this means that it may be necessary to change the dose of other medicines. If you are using any of the following medicines, tell your doctor or pharmacist before using Kevzara:

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

If any of the above applies to you (or if you are not sure), talk to 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 are planning to have a baby.

• Do not use Kevzara if you are pregnant unless your doctor specifically recommends it.
• The effects of Kevzara on the fetus are unknown.
• Your doctor and you must decide if you should receive treatment with Kevzara if you are breastfeeding.

Driving and using machines

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

KEVZARA contains polysorbate 20

This medicine contains 2.28 mg of polysorbate 20 in each 1.14 ml of solution for injection equivalent to 2 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergy.

3. How to use Kevzara

Treatment should be initiated by a doctor with experience in the diagnosis and treatment of RA or polymyalgia rheumatica. Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are not sure, talk to your doctor or pharmacist again.

Adult patients

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

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

Kevzara is given 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 can be injected by you or administered by a caregiver after receiving adequate training.
• Follow carefully the “Instructions for Use” included in the pack.
• 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 forget to use a dose of Kevzara

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

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

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

If you are not sure when you should inject your next dose, ask your doctor, pharmacist, or nurse for instructions.

If you stop treatment with Kevzara

Do not stop treatment with 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.

Severe side effect

Tell your doctor immediatelyif you think you have an infection(which may affect up to 1 in 10 people). 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:

Adults

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

• low white blood cell counts according to blood tests

Common(may affect up to 1 in 10 people)

• infections of the nasal passages or throat, congestion or runny nose, and sore throat (upper respiratory tract infection)
• urinary tract infection
• oral herpes
• low platelet counts according to blood tests
• high cholesterol, high triglycerides according to blood tests
• abnormal liver function tests
• reactions at the injection site (including redness and itching)
• inflammation of the deep skin tissue
• lung infection

Uncommon(may affect up to 1 in 100 people)

• diverticulitis (a disease that affects the intestine, often with stomach pain, nausea, and vomiting, fever, and constipation, or less frequently diarrhea)

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

• perforation in the stomach or intestines (a hole that develops in the wall of the intestine)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is 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. Storage of 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 and on the carton after EXP. The expiry date is the last day of the month stated.

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

• Do not freeze.
• Once removed from the refrigerator, do not store Kevzara at a temperature above 25 °C.
• Write the date you removed the syringe from the refrigerator on the space provided on the outer carton.
• Use the syringe within 14 days of removal from the refrigerator or insulated bag.
• Keep the syringe in the original package to protect from light.

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

After use, put the syringe in a puncture-resistant container. Keep the container out of the 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 no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Kevzara Composition

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

Product Appearance and Container Contents

Kevzara is a clear, colorless 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 multi-packs containing 3 packs, each with 2 pre-filled syringes.

Only some pack sizes may be marketed.

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

Marketing Authorization Holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer

Sanofi Winthrop Industrie

1051 Boulevard Industriel

76580 Le Trait,

France

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product 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 a “syringe” in these instructions). It contains 200 mg of Kevzara for subcutaneous injection once every two weeks.

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

What to Do

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

What Not to Do

• Do not use the syringe if it has been damaged or if the needle cap is missing or not attached.
• Do not remove the needle cap until you are ready for injection.
• Do not touch the needle.
• Do not try to put the needle cap back on the syringe.
• Do not reuse the syringe.
• Do not freeze or heat the syringe.
• Once removed from the refrigerator, do not store the syringe at a temperature above 25 °C.
• Do not expose the syringe to direct sunlight.
• Do not inject through clothing.

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

Step A: Preparation for Injection

1. Prepare all the equipment you will need in a clean and flat area.
   • You will need an alcohol swab, a cotton ball or gauze, and a sharps container.
   • Remove a syringe from the packaging by holding it in the middle of the syringe body. Store the remaining syringe in the packaging in the refrigerator.

1. Look at the label.
   • Check that you have the correct medicine and the correct dose.
   • Check the expiration date (EXP).

• Do notuse the syringe if it is expired.

1. Look at the medicine.
   • Check that the liquid is clear and colorless to pale yellow.
   • You may see an air bubble; this is normal.
   • Do notproceed with the injection if the liquid is cloudy, discolored, 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 notuse the syringe if it has been out of the refrigerator for more than 14 days.
   • Do notheat the syringe; let it warm up naturally.
   • Do notexpose the syringe to direct sunlight.

1. Choose the injection site.
   • You can inject into your thigh or stomach (abdomen) except for the 5 cm around your navel. If someone is giving you the injection, you can also choose the outer and upper part of the arm.
   • Change the injection site each time you inject.
   • Do notinject into sensitive skin, damaged skin, or skin with bruises or scars.

1. Prepare the injection site.
   • Wash your hands.
   • Disinfect the skin with an alcohol swab.
   • Do nottouch the injection site again before the injection.

Step B: Perform the Injection - Proceed with Step B only after completing Step A “Preparation for Injection”

1. Remove the needle cap.
   • Hold the syringe by the middle of the syringe body, with the needle pointing away from you.
   • Keep your hand away from the plunger.
   • Do notremove air bubbles from the syringe.
   • Do notremove the needle cap until you are ready for the injection.
   • Do notput the needle cap back on.

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

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

1. Push the plunger down.
   • Push the plunger slowly 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 as the injection.
   • If you see any blood, press the injection site with a cotton ball or gauze.
   • Do notrub the skin after the injection.

1. Put the used syringe and needle cap into a sharps container immediately after use.
   • Always keep the container out of the sight and reach of children.
   • Do notput the needle cap back on.
   • Do notthrow the used syringe away in the trash.
   • Do notthrow the used sharps container away in the trash unless local regulations allow it. Ask your doctor, pharmacist, or nurse how to dispose of the container.