Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - kevzara

Document Subject

Generated Narrative: MedicinalProductDefinition mp9731e4b0c59c667008c1be9f642fafee

identifier: http://ema.europa.eu/identifier/EU/1/17/1196/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Kevzara 150 mg solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-9731e4b0c59c667008c1be9f642fafee

identifier: http://ema.europa.eu/identifier/EU/1/17/1196/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - kevzara

Attesters

What is in this leaflet

1. What Kevzara is and what it is used for
2. What you need to know before you use Kevzara
3. How to use Kevzara
4. Possible side effects
5. How to store Kevzara
6. Contents of the pack and other information

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.

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: 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 for low blood cell count, liver problems, or changes in your 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 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 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.

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 syringe

• 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 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, 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 (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).

Uncommon (may affect up to 1 in 100 people)

• infection of the lungs
• inflammation of the deep skin tissue
• 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 of the refrigerator, do not store Kevzara above 25 C.
• Write down the date of removal from the refrigerator in the space provided on the outer carton.
• Use the syringe within 14 days after taking it out of the refrigerator or the insulated bag.
• Keep the syringe in the original carton in order to protect from light.

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

After use, put the syringe 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.

What Kevzara contains

• The active substance is sarilumab.
• The other ingredients are arginine, histidine, polysorbate 20, 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 syringe.

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

Not all pack sizes may be marketed.

Kevzara is available as 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Sanofi Belgium T l/Tel: +32 (0)2 710 54 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91
Swixx Biopharma EOOD .: +359 (0)2 4942 Luxembourg/Luxemburg Sanofi Belgium
T l/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

esk republika sanofi-aventis, s.r.o. Tel: +420 233 086 Magyarorsz g SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0Danmark Sanofi A/S Tlf: +45 45 16 70 Malta Sanofi S.r.l. Tel: +39. 02 39394Deutschland Sanofi-Aventis Deutschland GmbH Telefon: 0800 04 36 Telefon aus dem Ausland: +49 69 305 70 Nederland Sanofi B.V. Tel: +31 20 245 4Eesti Swixx Biopharma O
Tel: +372 640 10 Norge sanofi-aventis Norge AS Tlf: +47 67 10 71
Sanofi-Aventis AEBE : +30 210 900 16 sterreich sanofi-aventis GmbH Tel: +43 1 80 185 0

Espa a sanofi-aventis, S.A.
Tel: +34 93 485 94 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 France Sanofi Winthrop Industrie T l: 0 800 222 Portugal Sanofi - Produtos Farmac uticos, Lda Tel: +351 21 35 89 Appel depuis l tranger : +33 1 57 63 23 Hrvatska
Swixx Biopharma d.o.o. Tel: +385 1 2078 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Slovenija Swixx Biopharma d.o.o.
Tel: +386 1 235 51 sland Vistor hf. S mi: +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Italia Sanofi S.r.l. Tel: 800 13 12 12 (domande di tipo tecnico)
800 536389 (altre domande)

Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200
C.A. Papaellinas Ltd. : +357 22 741Sverige Sanofi AB Tel: +46 (0)8 634 50 Latvija Swixx Biopharma SIA
Tel: +371 6 616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in .

Detailed information on this medicine is available on the European Medicines Agency web site: