Kevzara 200 mg solucion inyectable en pluma precargada

Package Insert: Information for the Patient

Kevzara 150 mg Pre-filled Syringe

Kevzara 200 mg Pre-filled Syringe

sarilumab

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

In addition to this package insert, 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 “monoclonal antibody”.

What is Kevzara used for

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

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 decreasing 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, making you more susceptible to infection 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 Kevzara treatment, your doctor will perform TB tests.
• you have had viral hepatitis or other liver disease. Before using Kevzara, your doctor will perform blood tests 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 that do not subside.
• you have had any type of cancer.
• you have recently been vaccinated or are scheduled to be vaccinated.

If any of the above points 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. Blood tests should also be performed during your treatment. This is to check for low blood cell counts, liver problems, or changes in your cholesterol levels.

Each time you receive a new package of Kevzara, it is essential to note the medication name, administration date, and 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.

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

• a 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 apply to 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 adjust 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 apply to 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.

• Do not use Kevzara if you are pregnant unless your doctor recommends it specifically.
• The effects of Kevzara on the fetus are unknown.
• You and your doctor should decide whether you should receive Kevzara treatment while 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, do 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 experienced in the diagnosis and treatment of rheumatoid arthritis or polymyalgia rheumatica. Follow exactly the administration instructions for this medication 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 the dose of your medication based on the results of your blood tests.

Kevzara is administered as 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 yourself or administered by a caregiver after receiving proper training.
• Follow carefully the "Instructions for Use" included in the packaging.
• Use the pre-filled syringe exactly as described in the "Instructions for Use".

If You Use MoreKevzaraThan You Should

If you have used more Kevzara than you should, report this to 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 your 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 Interrupt Treatment withKevzara

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

If you have any other questions about the use of 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
• febrile herpes (“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)
• 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 notification 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 °C.
• Write the date when you remove the pen from the refrigerator in the space provided on the outer packaging.
• Use the pen within 14 days after removing it from the refrigerator or from the insulated bag.
• Keep the pen in the original packaging to protect it from light.

Do not use this medication if the solution in the pen is cloudy, discolored, or contains particles, or if any part of the preloaded pen appears damaged.

After use, place the pen in a sharp object container. Keep the container out of the sight and reach of children at all times. Ask your doctor, pharmacist, or nurse how to dispose of the container.

Medicines should not be thrown away 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 pen 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 injectable solution, presented in a pre-filled pen.

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

Only certain pack sizes may be marketed.

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

Marketing authorisation holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Responsible for manufacturing

Sanofi-Aventis Deutschland GmbH

Brüningstraße 50

Industriepark Höchst

65926 Frankfurt am Main

Germany

Genzyme Ireland Ltd.

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

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

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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 pen

sarilumab

Instructions for use

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

Important information

This device is a single-dose pre-filled pen (referred to as a “pen” 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 pen correctly before your first injection.

What to do

• Read these instructions carefully before using a pen.
• Check that you have the correct medicine and the correct dose.
• Store unused pens in the original packaging and keep them in the refrigerator at a temperature between 2 °C and 8 °C.
• Store the packaging in an insulated bag with a cold pack when travelling.
• Allow the pen to reach room temperature for at least 60 minutes before use.
• Use the pen within 14 days of removing it from the refrigerator or insulated bag.
• Keep the pen out of the sight and reach of children.

What not to do

Do not use the pen if it has been damaged or if the cap or needle cover is missing.

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 try to put the cap back on the pen.
• Do not re-use the pen.

• Do not freeze or heat the pen.
• Once removed from the refrigerator, do not store the pen at a temperature above 25 °C.

• Do not expose the pen 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 pen from the packaging by gripping the middle of the pen. Store the remaining pen in the refrigerator.

2. Check the label.

• Check that you have the correct medicine and the correct dose.
• Check the expiry date (EXP), this information is shown on the side of the pens.

• Do notuse the pen if it isexpired.

3. Check the window.

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

• Do notproceed with the injection if the liquid is cloudy, discoloured or contains particles.
• Do notuse the pen if the window is yellow solid.

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

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

• Do notuse the pen if it has been out of the refrigerator for more than 14 days.

• Do notheat the pen; allow it to come to room temperature naturally.
• Do notexpose the pen 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 bruised skin or skin with scars.

6. Prepare the injection site.

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

• Do nottouch the injection site again before the injection.

Step B: Administer the injection - Proceed with Step B only after completing Step A “Preparation for injection”

1. Turn and remove the orange cap.

• Do notremove the cap until you are ready to inject.
• Do notpress or touch the yellow needle cover with your fingers.

• Do notput the cap back on.

2. Place the yellow needle cover on your skin at an angle of approximately 90°.

• Make sure you can see the window.

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

• You will hear a “click” when the injection starts.

4. Continue to keep the pen firmly against your skin.

• The window will start to change colour to yellow.
• The injection may take up to 15 seconds (15 s).

5. You will hear a second click. Check that you can see that the entire window has turned completely yellow before removing the pen.

• If you do not hear the second click, you must continue to check to see if the window has turned completely yellow.

• If the window has not turned completely yellow,do notadminister a second dose without consulting your healthcare professional.

6. Remove the pen from your skin.

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

• Do notrub the skin after the injection.

7. Put the used pen and cap in asharps containerimmediately after use.

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

• Do notput the cap back on.
• Do notthrow away used pens in the trash.
• Do notthrow away the sharps container in the trash unless local regulations permit it. Ask your doctor, pharmacist or nurse how to dispose of the sharps container.