Kevzara

Italy

Brand name Kevzara

Form solution for injection in pre-filled syringe

Active substance / Dosage

SARILUMAB

Prescription type Restricted prescription – dispensable on hospital or specialist prescription

ATC code

L04AC14

Registration number 045491

Manufacturer SANOFI WINTHROP INDUSTRIE

Kevzara solution for injection in pre-filled syringe

Instructions for Use

Table of Contents

Kevzara 150 mg solution for injection in pre-filled syringe, 200 mg solution for injection in pre-filled syringe
1. What Kevzara is and what it is used for
2. What you should know before using Kevzara
3. How to use Kevzara
4. Possible side effects
5. How to store Kevzara
6. Package contents and other information
Instructions for use
2. Check the label.
3. Inspect the medicine.
5. Select the injection site.
6. Prepare the injection site.
1. Remove the needle cap.
2. Lift the skin with two fingers.
3. Insert the needle into the skin fold at an angle of approximately 45 degrees.
4. Push the plunger down.
5. Before removing the needle, check that the syringe is empty.
6. Place the used syringe and cap into a puncture-resistant container
Instructions for use
2. Check the label.
3. Inspect the medicine.
5. Select the injection site.
6. Prepare the injection site.
1. Remove the needle cap.
2. Lift the skin with two fingers.
3. Insert the needle into the skin fold at an angle of approximately 45 degrees.
4. Push the plunger down.
5. Before removing the needle, make sure the syringe is empty.
6. Place the used syringe and cap into a puncture-resistant container
Patient Information Leaflet
Kevzara 150 mg solution for injection in pre-filled pen, 200 mg solution for injection in pre-filled pen
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. Package contents and other information
Instructions for use
2. Check the label.
3. Look at the viewing window.
4. Place the pen on a flat surface and allow it to reach room temperature
5. Select the injection site.
6. Prepare the injection site.
1. Twist or pull off the orange cap.
2. Press the yellow needle cap against the skin at an angle of approximately 90°.
3. Press and firmly hold the pen against the skin.
4. Continue to press the pen firmly against the skin.
6. Remove the pen from the skin.
7. Place the used pen and the cap into a puncture-resistant container
Instructions for use
2. Check the label.
3. Look at the viewing window.
4. Place the pen on a flat surface and allow it to reach room temperature
5. Select the injection site.
6. Prepare the injection site.
1. Twist or pull off the orange cap.
2. Press the yellow needle cap against the skin at an angle of approximately 90°.
3. Press and firmly hold the pen against the skin.
4. Continue to press the pen firmly against the skin.
6. Remove the pen from the skin.
7. Place the used pen and the cap into a puncture-resistant container

Patient Information Leaflet

Kevzara 150 mg solution for injection in pre-filled syringe, 200 mg solution for injection in pre-filled syringe

sarilumab
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4. In addition to this patient information leaflet, you will be given a patient safety card containing important safety information required before and during treatment with Kevzara.

Contents of this leaflet

What Kevzara is and what it is used for
What you need to know before using Kevzara
How to use Kevzara
Possible side effects
How to store Kevzara
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 adult patients with moderately to severely active rheumatoid arthritis when previous therapy has not been effective or was not tolerated. Kevzara can be used alone or together with a medicine called methotrexate.
It may help to:

slow down joint damage;
improve the ability to perform daily activities.

Kevzara is used to treat adults with polymyalgia rheumatica after treatment with corticosteroids has not worked or in case of relapse during corticosteroid dose reduction (tapering). Kevzara can be used alone or in combination with a medicine called corticosteroid.

How Kevzara works

Kevzara binds to another protein called the "interleukin-6 (IL-6) receptor" and blocks its action.
IL-6 plays an important role in causing symptoms of rheumatoid arthritis, such as pain, joint swelling, morning stiffness, and fatigue.

2. What you should 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 an active serious infection.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse if:

You have any infection or have frequent infections. Kevzara can reduce your body’s ability to fight infections: this means it may make you more susceptible to infections or worsen any existing infections you may have.
You have tuberculosis (TB), symptoms of TB (persistent cough, weight loss, tiredness, mild fever), or have been in close contact with someone who has TB. Before you are given Kevzara, your doctor will check whether you have TB.
You have had viral hepatitis or any other liver disease. Before you use Kevzara, your doctor will carry out a blood test to check your liver function.
You have had diverticulitis (a condition affecting the lower intestine), or a stomach or intestinal ulcer, or develop symptoms such as fever and abdominal pain that do not go away.
You have had any type of cancer.
You have recently been vaccinated or are planning to be vaccinated.

If any of these apply to you (or if you are unsure), talk to your doctor, pharmacist, or nurse before using Kevzara.
You will have blood tests before you are given Kevzara. You will also have these tests during treatment to monitor whether you have low blood cell counts, liver problems, or changes in cholesterol levels.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age.
Other medicines and Kevzara
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Kevzara may affect the action of certain other medicines. Some other medicines may also affect the action of Kevzara.
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 to treat rheumatoid arthritis

If any of these apply to you (or if you have any doubts), talk to your doctor or pharmacist.

Kevzara may affect the action of certain medicines; this means that the dose of other medicines may need to be adjusted. If you are taking any of the following medicines, tell 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 these apply to you (or if you have any doubts), talk to your doctor or pharmacist.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking Kevzara.

Do not take Kevzara if you are pregnant, unless specifically advised by your doctor.
The effects of Kevzara on the unborn baby are unknown.
You and your doctor will need to decide whether to use 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 using Kevzara, you should not drive or operate machinery.
KEVZARA contains polysorbate 20
This medicine contains 2.28 mg of polysorbate 20 per 1.14 mL of injectable solution, equivalent to 2 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Kevzara

Treatment should be initiated by a physician experienced in the diagnosis and treatment of rheumatoid arthritis or polymyalgia rheumatica. Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

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

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

Kevzara is administered by subcutaneous injection (an injection under the skin).
Learning how to use the pre-filled syringe

Your doctor, pharmacist, or nurse will show you how to inject Kevzara. By following these instructions, you will be able to self-inject Kevzara or have it administered by a caregiver.
Carefully follow the “Instructions for Use” provided 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, speak to your doctor, pharmacist, or nurse.
If you miss a dose of Kevzara
If 3 days or fewer have passed since the missed dose:

inject the missed dose as soon as possible;
then inject the next dose on the usual day and at the usual time.

If 4 or more days have passed, inject the next dose on the usual day and at the usual time. Do not inject a double dose to make up for the missed injection.
If you are unsure about when to inject the next dose, consult your doctor, pharmacist, or nurse for instructions.
If you stop using Kevzara
Do not stop using Kevzara without consulting your doctor.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects
Contact 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 side effects
Talk to 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 count, detected by blood tests

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

Sinus or throat infections, blocked or runny nose, and sore throat (“upper respiratory tract infections”)
Urinary tract infections
Blisters (“oral herpes”)
Low platelet count, detected by blood tests
High cholesterol, high triglycerides, detected by blood tests
Abnormal liver function tests
Injection site reactions (including redness and itching)
Inflammation of deep skin tissue
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, diarrhoea)

Rare (may affect up to 1 in 1000 people):

Perforation of the stomach or intestine (a hole developing in the intestinal wall)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex 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 and the carton after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C).

Do not freeze.
Once removed from the refrigerator, do not store Kevzara above 25 °C.
Write the date of removal from the refrigerator in the designated space on the outer packaging.
Use the syringe within 14 days after removing it from the refrigerator or the cooling 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 or has changed colour, or if it contains particles, or if any part of the pre-filled syringe appears damaged.
After use, place the syringe in a puncture-resistant container. Always keep the container out of the sight and reach of children. Consult your doctor, pharmacist, or nurse for instructions on how to dispose of the container.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Kevzara contains

The active substance is sarilumab.
The other components are: arginine, histidine, polysorbate 20, sucrose and water for injection.

Description of the appearance of Kevzara and contents of the pack
Kevzara is a clear, injectable solution, colourless to pale yellow, contained in a pre-filled syringe.
Each pre-filled syringe contains 1.14 ml of solution, which constitutes a single dose. Kevzara is
available in packs containing 1 or 2 pre-filled syringes, and in a multiple pack comprising 3 packs, each containing 2 pre-filled syringes.
Not all pack sizes may be marketed.
Kevzara is available in 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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Sanofi Belgium Swixx Biopharma UAB
Tél/Tel: +32 (0)2 710 54 00 Tel: +370 5 236 91 40

България Luxembourg/Luxemburg
Swixx Biopharma EOOD Sanofi Belgium
Тел.: +359 (0)2 4942 480 Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika Magyarország
Sanofi s.r.o. SANOFI-AVENTIS Zrt.
Tel: +420 233 086 111 Tel.: +36 1 505 0050

Danmark Malta
Sanofi A/S Sanofi S.r.l.
Tlf: +45 45 16 70 00 Tel: +39. 02 39394275

Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Sanofi B.V.
Telefon: 0800 04 36 996 Tel: +31 20 245 4000
Telefon aus dem Ausland: +49 69 305 70 13

Eesti Norge
Swixx Biopharma OÜ sanofi-aventis Norge AS
Tel: +372 640 10 30 Tlf: +47 67 10 71 00

Ελλάδα Österreich
Sanofi-Aventis Μονοπρόσωπη AEBE sanofi-aventis GmbH
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0

España Polska
sanofi-aventis, S.A. Sanofi Sp. z o.o.
Tel: +34 93 485 94 00 Tel.: +48 22 280 00 00

France Portugal
Sanofi Winthrop Industrie 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
Swixx Biopharma d.o.o. Sanofi Romania SRL
Tel: +385 1 2078 500 Tel: +40 (0) 21 317 31 36

Ireland Slovenija
sanofi-aventis Ireland Ltd. T/A SANOFI Swixx Biopharma d.o.o.
Tel: +353 (0) 1 403 56 00 Tel: +386 1 235 51 00

Ísland Slovenská republika
Vistor hf. Swixx Biopharma s.r.o.
Sími: +354 535 7000 Tel: +421 2 208 33 600

Italia Suomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800 13 12 12 (technical enquiries) Puh/Tel: +358 (0) 201 200 300
800 536389 (other enquiries)

Κύπρος Sverige
C.A. Papaellinas Ltd. Sanofi AB
Τηλ: +357 22 741741 Tel: +46 (0)8 634 50 00

Latvija United Kingdom (Northern Ireland)
Swixx Biopharma SIA sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +371 6 616 47 50 Tel: +44 (0) 800 035 2525

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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

Instructions for use

The parts of the Kevzara prefilled syringe are illustrated in this figure.

Diagram of a pre-filled Kevzara 150 mg syringe with labels indicating various parts of the device and a close-up detail of the

Plunger
Finger grip
Label
Syringe barrel
Needle cap
Needle
Important information
This device is a single-dose prefilled syringe (referred to as "syringe" in these instructions).
It contains 150 mg of Kevzara for subcutaneous injection (injection under the skin) once every two
weeks.
Ask your healthcare provider to show you the correct way to use the syringe before your first injection.
Do the following
✓ Read all instructions carefully before using a syringe.
✓ Check that you have the correct medicine and correct dose.
✓ Keep unused syringes in their original packaging and store them in the refrigerator at 2 °C to
8 °C.
✓ Keep the packaging in an insulated bag together with a cooling 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.
Avoid the following

Do not use the syringe if it has been damaged or if the needle cap is missing or detached.
Do not remove the needle cap until just before you are ready to give the injection.
Do not touch the needle.
Do not attempt to re-cap the syringe.
Do not reuse the syringe.
Do not freeze or artificially heat the syringe.
Once removed from the refrigerator, do not store the syringe above 25 °C.
Do not expose the syringe to direct sunlight.
Do not inject through clothing.
If you have any doubts, consult your doctor, pharmacist, or nurse.
Step A: Prepare for injection

Prepare all the equipment you will need on a clean, flat work surface.
- You will need an alcohol swab, cotton ball or gauze, and a puncture-resistant container.
- Remove one syringe from the packaging by holding it at the center of the main body. Keep the remaining syringe in its packaging in the refrigerator.

2. Check the label.

Make sure you have the correct medicine and the correct dose.
Check the expiration date (Exp). Do not use the syringe if this date has passed.

Illustration of an eye observing a magnified view of the Kevzara drug name with dosage 150 mg on a white and orange background

3. Inspect the medicine.

Check that the liquid is clear and colorless to slightly yellow.
A small air bubble may be visible, which is normal. Do not inject the liquid if it is cloudy, has changed color, or contains particles.

Diagram showing a magnification of a cylindrical container filled with a light yellow liquid on a white background

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 out of the refrigerator for more than 14 days.

Do not heat the syringe artificially; let it warm up naturally.
Do not expose the syringe to direct sunlight.

Pre-filled Kevzara 150 mg syringe with orange grip and a circular diagram vertically divided between white and light blue

30
min.

5. Select the injection site.

You can administer the injection in the thigh or the abdomen, except for the area within 5 cm around the navel. If someone else is administering the injection, the outer area of the upper arm may also be used.
Change the injection site each time you give an injection. Do not inject into skin that is tender, damaged, bruised, or scarred.

Human body diagram with orange areas on shoulders, abdomen, and thighs indicating injection sites, with a legend below

6. Prepare the injection site.

Wash your hands.
Clean the skin with an alcohol swab. Do not touch the injection site again before the injection.

Step B: Give the injection – perform Step B only after completing Step A
"Prepare for injection"

1. Remove the needle cap.

Hold the syringe by the center of the main body with the needle pointing away from you.
Keep your hand away from the plunger. Do not remove any air bubbles that may be present in the syringe.

Do not remove the needle cap until you are ready to perform the injection.
Do not recap the needle.

Two hands preparing a syringe with yellow liquid and orange grip to inject its contents into a small black container, with an orange arrow

2. Lift the skin with two fingers.

Use your thumb and index finger to grasp the skin at the injection site to form a skin fold.

A hand pinching and lifting a fold of light skin on a body surface at

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

A hand holding a syringe injecting liquid into the arm at a 45-degree angle indicated by a graphic and an orange arrow

4. Push the plunger down.

Slowly push the plunger down all the way until the syringe is empty.

A hand holding a pre-filled Kevzara 150 mg syringe with an orange arrow indicating the direction of downward pressure

5. Before removing the needle, check that the syringe is empty.

Remove the needle at the same angle at which it was inserted.
If you see blood, press a cotton ball or gauze on the site. Do not rub the skin after the injection.

A hand holding a Kevzara 150 mg syringe tilted toward the skin with an orange arrow indicating the insertion movement

6. Place the used syringe and cap into a puncture-resistant container

immediately after use.

Always keep the container out of sight and reach of children. Do not recap the needle.

Do not dispose of the used syringe in household waste.
Do not dispose of the puncture-resistant container in household waste unless permitted
by local regulations. Consult your doctor, pharmacist, or nurse for
instructions on how to dispose of the container.

A hand holds a Kevzara syringe with needle pointing downward above a gray support, with orange arrows indicating downward movement

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

Instructions for use

The parts of the Kevzara pre-filled syringe are illustrated in this figure.

Plunger

Grip for

fingers

Label
Body
of the
syringe
Needle
cap
Needle

Important information
This device is a single-dose prefilled syringe (referred to as “syringe” in these instructions).
It contains 200 mg of Kevzara for injection under the skin (subcutaneous injection) once every two
weeks.
Ask your healthcare provider to show you the correct way to use the syringe before your first injection.

Do
✓ Read all instructions carefully before using a syringe.
✓ Check that you have the correct medicine in the correct dose.
✓ Keep unused syringes in their original packaging and store them in the refrigerator at 2 °C to
8 °C.
✓ Keep the package in a cooler bag together with a cooling 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 cooler 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 if the needle cap is missing or detached.
Do not remove the needle cap until just before you are ready to administer the injection.
Do not touch the needle.
Do not attempt to re-cap the syringe.
Do not re-use the syringe.
Do not freeze or artificially heat the syringe.
After removal from the refrigerator, do not store the syringe above 25 °C.
Do not expose the syringe to direct sunlight.
Do not inject through clothing.

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

Step A: Prepare for the injection

Prepare all the equipment you will need on a clean, flat surface.
- You will need an alcohol swab, a cotton ball or gauze, and a puncture-resistant container.
- Remove one syringe from the package by holding it at the center of the main body. Store the remaining syringe in its packaging in the refrigerator.