Active ingredient
- sarilumab
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 04425/0829.
Kevzara 200 mg solution for injection pre filled pen
Package leaflet: Information for the patient
Kevzara® 150 mg solution for injection in pre-filled pen
Kevzara® 200 mg solution for injection in pre-filled pen
sarilumab
Is this leaflet hard to see or read? Phone 0800 035 2525 for help
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
In addition to this leaflet, you will be given a patient alert card, which contains important safety information that you need before and during treatment with Kevzara.
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
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 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:
How Kevzara works
2. What you need to know before you use Kevzara
Do not use Kevzara:
Warnings and precautions
Talk to your doctor, pharmacist, or nurse if:
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:
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:
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.
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.
3. How to use Kevzara
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.
Learning how to use the pre-filled pen
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:
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:
Very Common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1000 people):
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 after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C to 8 °C).
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.
6. Contents of the pack and other information
What Kevzara contains
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. It is available in pack sizes of 1 or 2 or a multipack of 6 pre-filled pens (3 packs of 2).
Not all pack sizes may be marketed.
Kevzara is available as 150 mg or 200 mg pre-filled pens.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
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 2021
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Kevzara 200 mg solution for injection in a pre-filled pen
sarilumab
Instructions for use
The parts of the Kevzara pre-filled pen are shown in this picture.
Important information
This device is a single-dose pre-filled pen (called “pen” in these instructions). It contains 200 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.
Ask your healthcare professional to show you the right way to use the pen before your first injection.
Do
Do not
If you have any further questions, ask your doctor, pharmacist or nurse or call the sanofi number on the package leaflet.
Step A: Get ready for an injection
1 Prepare all the equipment you will need on a clean, flat working surface.
2 Look at the label.
3 Look at the window.
4 Lay the pen on a flat surface and allow it to warm up to room temperature (<25 °C) for at least 60 minutes.
5 Select the injection site.
6 Prepare the injection site.
Step B: Perform the injection – Perform Step B only after completing Step A “Get ready for an injection”
1 Twist or pull off the orange cap.
2 Put the yellow needle cover on your skin at roughly a 90° angle.
3 Press down and hold the pen firmly against your skin.
4 Keep holding the pen firmly against your skin.
5 There will be a second click. Check to see if the entire window has turned yellow before you remove the pen.
6 Pull the pen away from your skin.
7 Put your used pen and the cap into a puncture-resistant container right away after use.
835653
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT
+44 (0)800 035 2525