Patient leaflet - Kevzara 150 mg solution for injection in Pre-filled pen

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 moderately to severely active rheumatoid arthritis (RA) if previous therapy did not work well enough or was not tolerated. Kevzara can be used alone or together with a medicine called methotrexate (MTX).

It may help you by:

slowing down damage to joints
improving your ability to perform daily activities.

Kevzara is used to treat adults with polymyalgia rheumatica after corticosteroids have been used and did not work well or if you experience a relapse while decreasing the dose of corticosteroids (taper). Kevzara can be used alone or together with a medicine called corticosteroid.

How Kevzara works

Kevzara attaches to another protein called interleukin-6 (IL-6) receptor and blocks its action.
IL-6 plays a major role in the symptoms of RA such as pain, swollen joints, morning stiffness, and fatigue.

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 an active severe infection.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse if:

you have any infection or, you get a lot of infections. Kevzara can lower your body's ability to fight infection and this means it can make you more likely to get infections or make your infection worse.
you have tuberculosis (TB), symptoms of TB (persistent cough, weight loss, listlessness, mild fever), or have been in close contact with someone with TB. Before you are given Kevzara, your doctor will check you for TB.
you have had viral hepatitis or other liver disease. Before you use Kevzara, your doctor will do a blood test to check your liver function.
- you have had diverticulitis (a condition of the lower bowel) or ulcers in your stomach or intestines, or develop symptoms such as fever and stomach (abdominal) pain that does not go away.
- you have ever had any type of cancer.
- you have recently had any vaccination or are going to have a vaccination.

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

You will have blood tests before you are given Kevzara. You will also have the tests during your treatment. This is to check if you have a low blood cell count, liver problems, or changes in your cholesterol levels.

Every time you get a new pack of Kevzara, it is important you note down the name of the medicine, the date of the administration and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.

Children and adolescents

The Kevzara pre-filled pen has not been studied in children 2 years of age and older with polyarticular juvenile idiopathic arthritis (pJIA) and is not

intended for use in children. Kevzara is not recommended in children under 2 years of age. Kevzara must not be given to children with pJIA weighing 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 can affect the way some other medicines work. Also some other medicines can 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 (JAK) inhibitors” (used for diseases like
rheumatoid arthritis and cancer)
other biological medicines used in the treatment of RA. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist.
Kevzara can affect the way some medicines work: this means the dose of other medicines may need changing. If you are using any of the following medicines, tell your doctor or pharmacist before using Kevzara:
- statins, used to reduce cholesterol level
- oral contraceptives
- theophylline, used to treat asthma
- warfarin, used to prevent blood clots

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

Pregnancy and breast-feeding

Talk to your doctor before using Kevzara if you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby.

Do not take Kevzara if you are pregnant – unless your doctor specifically recommends it.
The effects of Kevzara on an unborn baby are not known
You and your doctor should decide if you should use Kevzara if you are breast-feeding.

Driving and using machines

The use of Kevzara is not expected to affect your ability to drive or use machines. However, if you are feeling tired or unwell after you use Kevzara, 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 solution for injection which is equivalent to 2 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How to use Kevzara

Treatment should be started by a doctor experienced in the diagnosis and treatment of RA or polymyalgia rheumatica. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adult Patients

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

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

Kevzara is given as an

injection under the skin (called “subcutaneous” injection).

Learning how to use the pre-filled pen

Your doctor, pharmacist, or nurse will show you how to inject Kevzara. Following these instructions Kevzara can be self-injected or administered by a care-giver after proper training.
Carefully follow the
“Instructions for Use” provided in the carton.
Use the pre-filled pen
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 miss a dose of Kevzara

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

inject your missed dose as soon as you can.
then inject your next dose at your regular time.

If it has been 4 days or more, inject the next dose at your regular time. Do not inject a double dose to make up for a forgotten injection.

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

If you stop using Kevzara

Do not stop using 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.

Serious side effect

Tell your doctor straight away if you think you have an infection (which may affect up to 1 in every 10 people). The 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 shown by blood tests
<MAT>000522
Common (may affect up to 1 in 10 people):
- infections in your sinuses or throat, blocked or runny nose and sore throat (“upper respiratory tract infection”)
- urinary tract infection
- cold sores (“oral herpes”)
- low platelet counts shown by blood tests
- high cholesterol, high
  triglycerides shown by blood tests
- abnormal liver function tests
- injection site reactions (including redness and itching)
- inflammation of the deep skin tissue
- infection of the lungs

Uncommon (may affect up to 1 in 100 people):

diverticulitis (a disease affecting the gut 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 in stomach or intestines (a hole that develops in the wall of the gut)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator

(2 °C to 8 °C).

Do not freeze.
- Once taken out the refrigerator, do not store Kevzara above 25 ºC.
- Write down the date of removal from the refrigerator in the space provided on the outer carton.
- Use the pen within 14 days after taking it out of the refrigerator or the insulated bag.
- Keep the pen in the original carton in order to protect from light.

Do not use this medicine if the solution in the pen is cloudy, discoloured or contains particles, or if any part of the pre-filled pen looks damaged.

After use, put the pen into a puncture-resistant container. Always keep the container out of the sight and reach of children. Ask your doctor, pharmacist, or nurse how to throw away the container.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Kevzara contains

The active substance is sarilumab. Each pre-filled pen contains 150 mg or 200 mg sarilumab in 1.14 ml solution.
The other ingredients are arginine, histidine, polysorbate 20 (E432), sucrose, and water for injections.

What Kevzara looks like and contents of the pack

Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled pen.

Each pre-filled pen contains 1.14 ml of solution delivering one single dose. Kevzara is available in packs containing 1 or 2 pens and in multipacks comprising 3 cartons, each containing 2 pens.

Not all pack sizes may be marketed.

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

Marketing Authorisation Holder

Sanofi

410 Thames Valley Park Drive Reading

Berkshire

RG6 1PT

Tel: 0800 035 2525

Email: uk-medicalinformation@ sanofi.com

Manufacturer

Sanofi-Aventis

Deutschland GmbH

Brüningstraße 50

Industriepark Höchst

65926 Frankfurt am Main Germany

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in November 2024.

The parts of the Kevzara

Step A: Get ready for an injection

pre-filled pen are shown

^{in this picture.}Important information

Legende / Legend

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

Lay the pen on a flat surface and allow it to warm up to room temperature (<25 °C)

This device is a single-dose pre-filled pen (called “pen” in these instructions). It contains 150 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.

You will need an alcohol wipe, a cotton ball or gauze,
and a puncture-resistant container.
for at least 60 minutes.
Take one pen out of the packaging by holding the middle
- Using the pen at room temperature may
  60 mins

Ask your healthcare professional to show you the right way to use the pen before your first injection.

of the pen body. Keep the remaining pen in the carton in the refrigerator.

make the injection more comfortable. ✗ Do not use the pen if it has been out of the refrigerator for more than 14 days. ✗ Do not heat the pen; let it warm up on its own. ✗ Do not expose the pen to direct sunlight. Look at the label.

Do

Do not

2 Label

Read all of the instructions carefully
✗ Do not use a pen if it has been
- Check that you have the correct
  medicine and the correct dose.

before using a pen.

damaged or the cap is missing or not attached.

Check the expiry date (EXP), this
5
Select the injection site.
Check that you have the correct
is shown on the side of the pens.
- You can inject into your thigh or belly

✗ Do not remove the cap until just

medicine and the correct dose.

✗ Do not use the pen if the date

(abdomen) except for the 5 cm around your belly button (navel). If somebody else gives you the injection, you can also use the outer area of the upper arm.

before you are ready to inject.

Keep unused pens in the original
has passed.
✗ Do not press or touch the yellow
carton and store in the refrigerator

Window

between 2 ºC and 8 ºC.

needle cover with your fingers.

Keep the carton in an insulated bag
✗ Do not try to put the cap back on a
- Change injection site each time you

with an ice pack when travelling.

pen.

inject.

✗ Do not inject into skin that is tender,

Let the pen warm up to room
✗ Do not re-use the pen.
3
damaged or has bruises or scars. Look at the window.
- Check that the liquid is clear

temperature for at least 60 minutes

✗ Do not freeze or heat the pen.

Injection sites

and colourless to pale yellow.

before using.

Yellow needle cover

✗ Once removed from the refrigerator,

You may see an air bubble,
Use the pen within 14 days after
do not store the pen above 25 ºC.
this is normal.
taking it out of the refrigerator or
✗ Do not expose the pen to direct
Unused
✗ Do not inject if the liquid
insulated bag.
sunlight.
is cloudy, discoloured or
6
Prepare the injection site.
Keep the pen out of the sight and
✗ Do not inject through your clothes.
contains particles.
- Wash your hands.

reach of children.

Cap

✗ Do not use if the window is

Clean skin with an alcohol wipe. ✗ Do not touch the injection site again before the

solid yellow.

injection.

Used

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

Step B: Perform the injection – Perform Step B only after completing Step A “Get ready for an injection”

household waste unless your local guidelines permit this. Ask your doctor, pharmacist or nurse how to throw away the container. Twist or pull off the orange cap. Put the yellow needle

Press down and hold the pen firmly against your skin.

Keep holding the pen firmly against your skin.

1 4

2

3

cover on your skin at roughly a 90° angle.

✗ Do not remove the cap

until you are ready to

Make sure you can see the
- There will be a “click” when
  - The window will start to

inject.

window.

the injection starts.

turn yellow.

✗ Do not press or touch

The injection can take up

the yellow needle cover

to 15 seconds.

with your fingers.

Up to

✗ Do not put the cap back

first

click!

15 secs

on.

Cap

There will be a second click. Check to see if the entire window has turned yellow before you remove the pen.

Pull the pen away from your skin. Put your used pen and the cap into a puncture-resistant

5

6

7

container right away after use.

If you see any blood, press a cotton ball or
- Always keep the container out of the sight and reach of children. ✗ Do not put the cap back on.
If you do not hear the second click, you should still check
gauze on the site.
✗ Do not rub your skin after the injection.
✗ Do not throw the used pens in household waste. ✗ Do not dispose of your used puncture-resistant container in your
to see if the window has turned fully yellow.
second

✗ If the window does not turn fully yellow, do not give