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 if previous therapy did not work well enough or was not tolerated. Kevzara can be used alone or together with a medicine called methotrexate.
It may help you by:
•slowing down damage to joints
•improving your ability to perform daily activities.

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 such as pain, swollen joints, morning stiffness, and fatigue.

Contraindications: 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.
Appropriate precautions for use; Special warnings: 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 or any vaccination or are going to have 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.
Children and adolescents
Kevzara is not recommended in children and adolescents under 18 years of age.
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 disease like rheumatoid arthritis and cancer)
• other biological medicines used in the treatment of rheumatoid arthritis
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.

Treatment should be started by a doctor experienced in the diagnosis and treatment of rheumatoid arthritis. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Kevzara is given as an injection under the skin (called “subcutaneous” injection). 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.
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.
• 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.

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:
Very Common (may affect more than 1 in 10 people):
•Low white blood cell counts shown by blood tests
Common (may affect up to 1 in 10 people):
•infections in your sinuses or throat, blocked or runny nose and sore throat (“upperrespiratory 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)
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.
By reporting side effects you can help provide more information on the safety of this medicine.

To report any side effect(s):
• Saudi Arabia:

The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000 E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Sanofi Pharmacovigilance: KSA_Pharmacovigilance@sanofi.com

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 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 or heat the pen.
•Once taken out the refrigerator, do not store Kevzara above 30 ºC.
•Write down the date of removal from the refrigerator in the space provided on theouter 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 it 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 recycle 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.