Kevzara 200 mg solucion inyectable en jeringa precargada

Prospect: information for the patient

Kevzara 150 mg injectable solution in pre-filled syringe

Kevzara 200 mg injectable solution in pre-filled syringe

sarilumab

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you alone, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

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

What is Kevzara

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

What is Kevzara used for

Kevzara is used to treat adults with active moderate to severe rheumatoid arthritis (RA) if previous treatment has not worked well or has not been tolerated. Kevzara can be used alone or with a medication called methotrexate.

It may help you:

• slow down joint damage
• improve your ability to perform daily activities.

Kevzara is used to treat adults with polymyalgia rheumatica after corticosteroids have been used and have not worked well or if you experience a relapse while reducing the dose of corticosteroids (gradual reduction). Kevzara can be used alone or with a medication called 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 major role in RA symptoms such as pain, joint inflammation, morning stiffness, and fatigue.

Do not use Kevzara:

• if you are allergic to sarilumab or any of the other components of this medication (listed in section 6).
• if you have an active severe infection.

Warnings and precautions

Consult your doctor, pharmacist, or nurse if:

• You have any infection or frequently contract infections. Kevzara may reduce your body's ability to fight infection: this means you may be more susceptible to contracting infections or worsening your infection.
• You have tuberculosis (TB), TB symptoms (persistent cough, weight loss, lack of appetite, 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 colon disease) or ulcers in your stomach or intestines, or develop symptoms such as fever and abdominal pain (abdominal pain) that do not subside.
• You have had any type of cancer.
• You have recently been vaccinated or are to be vaccinated.

If any of the above points concern you (or if you are unsure), consult 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 package of Kevzara, it is essential to note the name of the medication, the administration date, and the batch number (which appears on the package after “Batch”) and store this information in a safe place.

Children and adolescents

The pre-filled syringe of Kevzara has not been studied in children aged 2 years and older with AIJp 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 AIJp weighing less than 10 kg.

Other medications and Kevzara

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is because Kevzara may affect how other medications work. Other medications may also affect how Kevzara works.

Particularly, do not use Kevzara and inform your doctor or pharmacist if you are using:

• group of medications called “Janus kinase inhibitors (JAK)” (used for diseases such as rheumatoid arthritis and cancer)
• other biologic medications used in the treatment of RA.

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

Kevzara may affect how some medications work: this means that it may be necessary to modify the dose of other medications. If you are using any of the following medications, inform your doctor or pharmacist before using Kevzara:

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

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

Pregnancy and breastfeeding

Discuss with your doctor before using Kevzara if you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant.

• No 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 should decide whether you should receive Kevzara treatment if you are breastfeeding.

Driving and operating machinery

It is not expected that the use of Kevzara will affect your ability to drive or operate machinery. However, if you feel tired or experience discomfort after receiving Kevzara treatment, you should not drive or operate machinery.

KEVZARA contains polysorbate 20

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

Treatment should be initiated by a doctor with experience in diagnosing and treating rheumatoid arthritis or polymyalgia rheumatica. Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adult Patients

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

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

Kevzara is administered as a subcutaneous injection.

Learn How to Use the Preloaded Syringe

• Your doctor, pharmacist, or nurse will teach you how to inject Kevzara. Following these instructions, Kevzara can be injected by yourself or administered by a caregiver after receiving proper training.
• Follow carefully the "Instructions for Use" included in the packaging.
• Use the preloaded syringe exactly as described in the "Instructions for Use".

If You Use MoreKevzaraThan You Should

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

If You Forget to Use a Dose ofKevzara

If 3 days or less 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 compensate for the missed dose.

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

If You Discontinue Treatment withKevzara

Do not discontinue treatment with Kevzara without consulting your doctor.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effect

Inform your doctor immediatelyif you think you have aninfection(which may affect up to 1 in 10 people). The symptoms may include fever, sweating, or chills.

Other side effects

Inform your doctor, pharmacist, or nurse if you observe 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 in your nasal passages or throat,nasal congestion or discharge, and sore throat(upper respiratory tract infection)
• urinary tract infection
• fever blisters (oral herpes)
• low platelet counts according to blood tests
• high cholesterol, high triglycerides according to blood tests
• abnormal liver function test results
• reactions at the injection site (including redness and itching)
• deep skin tissue inflammation
• lung infection

Uncommon(may affect up to 1 in 100 people)

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

Rare(may affect up to 1 in 10,000 people)

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

Reporting side effects

If you experience any type of side effect, consult your doctor,pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly throughthe national reporting system included in theAppendix V.*.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

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

• Do not freeze.
• Once out of the refrigerator, do not store Kevzara at a temperature above 25 ºC.
• Write the date when you remove the syringe from the refrigerator in the space provided on the outer packaging.
• Use the syringe within 14 days after removing it from the refrigerator or from the insulated bag.
• Keep the syringe in the original packaging to protect it from light.

Do not use this medication 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, place the syringe in a sharp object container. Keep the container out of sight and reach of children at all times. Ask your doctor, pharmacist, or nurse how to dispose of the container.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the medicines that you no longer need. This will help protect the environment.

Composition of Kevzara

• 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, polisorbate 20 (E 432), sucrose, and water for injection.

Appearance of the product and contents of the pack

Kevzara is a transparent, colourless to pale yellow solution for injection, 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 pre-filled syringes of 150 mg or 200 mg.

Marketing authorisation holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer

Sanofi Winthrop Industrie

1051 Boulevard Industriel

76580 Le Trait,

France

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency: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 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 these 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.
• Store the pack 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 of removing it from the refrigerator or insulated 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 securely attached.

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

• Do not touch the needle.

• Do not attempt to reattach the needle cap.
• Do not re-use 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, consult 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 wipe, a cotton ball or gauze, and a sharps container.
• Remove a syringe from the pack by grasping the middle of the syringe body. Store the remaining syringe in the pack in the refrigerator.

2. Check the label.

• Check that you have the correct medicine and the correct dose.
• Check the expiry date (CAD).

• Do notuse the syringe if it is expired.

3. Check the medicine.

• Check that the liquid is transparent and colourless to pale yellow.
• You may see a bubble of air, which is normal.

• Do notproceed with the injection if the liquid is cloudy, discoloured or contains particles.

4. Place the syringe on a flat surface and allow it to reach room temperature (<25>

• 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; allow it to come to room temperature naturally.
• Do notexpose the syringe to direct sunlight.

5. Select the injection site.

• You can inject into your thigh or abdomen (except within 5 cm of your navel). If someone else is giving you the injection, you can also choose the outer and upper arm.
• Change the injection site each time you inject.

• Do notinject into sensitive, damaged, or haemorrhagic skin or scars.

6. Prepare the injection site.

• Wash your hands.
• Disinfect the skin with an alcohol wipe.

• Do nottouch the injection site 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, pointing the needle 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 to inject.
• Do notreattach the needle cap.

2. Pinch the skin.

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

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

4. Push the plunger down.

• Push the plunger slowly until it stops and the syringe is empty.

5. 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.

6. Put the used syringe and needle cap in a sharps container immediately after use.

• Always keep the sharps container out of sight and reach of children.

• Do notreattach the needle cap.
• Do notthrow the used syringe away.
• Do notthrow the sharps container away unless local regulations permit it. Ask your doctor, pharmacist or nurse how to dispose of the sharps container.