Patient leaflet - Kevzara 175 mg/ml solution for injection
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 children aged 2 years of age and older who have active polyarticular juvenile idiopathic arthritis (pJIA) if previous therapy did not work well. Kevzara can be used alone or together with a medicine called methotrexate (MTX).
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 rheumatoid arthritis (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/your child are/is allergic to sarilumab or
any of the other ingredients of this medicine (listed in section 6).
if you/your child have/has an active severe
infection.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse if:
You/your child have/has 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/your child have/has 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/your child have/has had viral hepatitis or
other liver disease. Before you use Kevzara, your doctor will do a blood test to check your liver function.
You/your child have/has 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/your child have/has ever had any type of
cancer.
You/your child have/has recently had any
vaccination or are going to have a vaccination.
If any of the above apply to you/your child (or you are not sure), talk to your doctor, pharmacist or nurse before using Kevzara.
You/your child will have blood tests before you are given Kevzara. You/your child 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/your child 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
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 (or your child if they are the patient) 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 pJIA
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/your child are feeling tired or unwell after you use Kevzara, you/your child should not drive/ride a bicycle 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 or your child have any known allergies.
3. How to use Kevzara
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Treatment should be started by a doctor experienced in the diagnosis and treatment of pJIA.
Children with pJIA (aged 2 and over)
The usual dose of Kevzara depends on your weight.
If you weigh 10 to less than 30 kg: the dose is
4 mg for every kilogram of body weight
If you weigh 30 kg or more: the dose is 3 mg
for every kilogram of body weight The dose is calculated based on your body weight at each administration.
Kevzara is given as an injection under the skin (called “subcutaneous” injection).
How Kevzara vial will be given
Kevzara will be given to you as an injection
under the skin (called “subcutaneous injection”) by a healthcare professional.
The dose you will be given will depend on
your body weight.
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:
Children
Very common (may affect more than 1 in 10 people):
- infections in your sinuses or throat, blocked or runny nose and sore throat (upper respiratory tract infection, nasopharyngitis)
- low white blood cell counts shown by blood tests (neutropenia)
- injection site reactions (including redness and itching)
Common (may affect up to 1 in 10 people):
- abnormal liver function tests (increased alanine aminotransferase)
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 25ºC.
- Write down the date of removal from the refrigerator in the space provided on the outer carton.
- Use the vial within 14 days after taking it out of the refrigerator.
- Keep the vial in the original carton in order to protect from light.
Do not use this medicine if the solution in the vial is cloudy, discoloured or contains particles, or if any part of the vial looks damaged.
Do not throw away any medicines via wastewater or household waste. Your healthcare professional is responsible for disposing of any unused product correctly. These measures will help protect the environment.
6. Contents of the pack and other information
What Kevzara contains
The active substance is sarilumab.
Each vial contains 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 vial.
Each vial contains 1.14 ml of solution. Kevzara is available in a pack containing 2 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi
410 Thames Valley Park Drive
Reading
Berkshire
RG6 1PT
UK
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 February 2026.