Kesimpta - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Kesimpta 20 mg solution for injection in pre-filled syringe ofatumumab

This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp 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.

• – Keep this leaflet. You may need to read it again.

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

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Kesimpta is and what it is used for

• 2. What you need to know before you use Kesimpta

• 3. How to use Kesimpta

• 4. Possible side effects

• 5. How to store Kesimpta

• 6. Contents of the pack and other information

1. What Kesimpta is and what it is used for

What Kesimpta is

Kesimpta contains the active substance ofatumumab. Ofatumumab belongs to a group of medicines called monoclonal antibodies.

What Kesimpta is used for

Kesimpta is used to treat adults with relapsing forms of multiple sclerosis (RMS).

How Kesimpta works

Kesimpta works by attaching to a target called CD20 on the surface of B cells. B cells are a type of white blood cell which are part of the immune system (the body’s defences). In multiple sclerosis, the immune system attacks the protective layer around nerve cells. B cells are involved in this process. Kesimpta targets and removes the B cells and thereby reduces the chance of a relapse, relieves symptoms and slows down the progression of the disease.

2. What you need to know before you use Kesimpta

Do not use Kesimpta

• – if you are allergic to ofatumumab or any of the other ingredients of this medicine (listed in

section 6).

• – if you have been told that you have severe problems with your immune system.

• – if you are suffering from a severe infection.

• – if you have cancer.

Warnings and precautions

Talk to your doctor before using Kesimpta

• – Kesimpta may cause the hepatitis B virus to become active again. Your doctor will perform a

blood test to check if you are at risk of hepatitis B infection. If this shows that you have had hepatitis B or are a carrier of the hepatitis B virus, your doctor will ask you to see a specialist.

• – Before you start treatment with Kesimpta, your doctor may check your immune system.

• – If you have an infection, your doctor may decide that you cannot be given Kesimpta or may

delay your treatment with Kesimpta until the infection is resolved.

• – Your doctor will check if you need any vaccinations before you start your treatment with

Kesimpta. If you need a type of vaccine called a live or live-attenuated vaccine, it should be given at least 4 weeks before you start Kesimpta treatment. Other types of vaccines should be given at least 2 weeks before you start Kesimpta treatment.

While using Kesimpta

Tell your doctor:

• – if you have a general injection-related reaction or a local injection-site reaction. These are the

most common side effects of Kesimpta treatment and are described in section 4. They usually occur in the 24 hours after Kesimpta is injected, in particular after the first injection. The first injection should take place under the guidance of a healthcare professional.

• – if you have an infection. You may get infections more easily or an infection you already have

may get worse. This is because the immune cells that Kesimpta targets also help to fight infection. Infections could be serious and sometimes even life-threatening.

• – if you plan to have any vaccinations. Your doctor will tell you whether the vaccination you need

is a live vaccine, a live-attenuated vaccine, or another type of vaccine. You should not be given live or live-attenuated vaccines during treatment with Kesimpta as this may result in infection. Other types of vaccines may work less well if they are given during treatment with Kesimpta.

Tell your doctor straight away if you get any of the following during your treatment with Kesimpta, because they could be signs of a serious condition:

• – if you think your multiple sclerosis is getting worse (e.g. weakness or visual changes) or if you

notice any new or unusual symptoms. These effects may indicate a rare brain disorder called progressive multifocal leukoencephalopathy (PML), which is caused by a virus infection.

Children and adolescents

Do not give this medicine to children and adolescents below 18 years of age because Kesimpta has not yet been studied in this age group.

Other medicines and Kesimpta

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist:

• – if you are taking, have recently taken or might take medicines that affect the immune system.

This is because these may have an added effect on the immune system.

• – if you plan to have any vaccinations (see “Warnings and Precautions” above).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy

You should avoid becoming pregnant while using Kesimpta and for 6 months after you stop using it.

If there is a possibility that you could become pregnant you should use an effective birth control method during treatment and for 6 months after stopping Kesimpta. Ask your doctor about the available options.

If you do become pregnant or think you may be pregnant during treatment or within 6 months after the last dose, tell your doctor straight away. Your doctor will discuss with you the potential risks of Kesimpta on pregnancy. This is because Kesimpta can reduce the number of immune cells (B cells) in both the mother and the unborn baby. Your doctor should report your pregnancy to Novartis. You can also report your pregnancy by contacting the local representative of Novartis (see section 6), in addition to contacting your doctor.

Breast-feeding

Kesimpta can pass into breast milk. Talk to your doctor about the benefits and risks before breast-feeding your baby while using Kesimpta.

Vaccination of newborn babies

Ask your doctor or pharmacist for advice before vaccinating your newborn baby if you have used Kesimpta during your pregnancy (see “Warnings and precautions” above).

Driving and using machines

Kesimpta is unlikely to affect your ability to drive and use machines.

Kesimpta contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How to use Kesimpta

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Kesimpta is given by subcutaneous injection (injection under your skin).

The first injection should take place under the guidance of a healthcare professional.

Kesimpta pre-filled syringes are for single use only.

For detailed instructions on how to inject Kesimpta, see “Instructions for use of Kesimpta pre-filled syringe” at the end of this leaflet.

‘QR code to be included’ +

You can use Kesimpta at any time of day (morning, afternoon or evening).

How much Kesimpta to use and how often to use it

Do not exceed the dose prescribed by your doctor.

• – The initial dosing is 20 mg Kesimpta administered on the first day of treatment (Week 0) and

after 1 and 2 weeks (Week 1 and Week 2). After these first 3 injections, there is no injection in the following week (Week 3).

• – Starting at Week 4 and then every month, the recommended dose is 20 mg Kesimpta.

  Time	Dose
  Week 0 (first day of treatment)	20 mg
  Week 1	20 mg
  Week 2	20 mg
  Week 3	No injection
  Week 4	20 mg
  Every month afterwards	20 mg

How long to use Kesimpta

Continue using Kesimpta every month for as long as your doctor tells you to.

Your doctor will regularly check your condition to determine whether the treatment is having the desired effect.

If you have questions about how long to use Kesimpta, talk to your doctor, pharmacist or nurse.

If you use more Kesimpta than you should

If you have injected too much Kesimpta, contact your doctor right away.

If you forget to use Kesimpta

To get the full benefit of Kesimpta, it is important that you have every injection on time.

If you have forgotten an injection of Kesimpta, inject yourself as soon as possible. Do not wait until the next scheduled dose. The timing of future injections should then be calculated from the day you injected this dose and not based on the original schedule (see also “How much Kesimpta to use and how often to use it” above).

If you stop using Kesimpta

Do not stop using Kesimpta or change your dose without talking with your doctor.

Some side effects can be related to a low level of B cells in your blood. After you stop treatment with Kesimpta your blood level of B cells will gradually increase to normal. This can take several months. During this time some side effects described in this leaflet may still occur.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects of Kesimpta are listed below. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse.

Very common (may affect more than 1 in 10 people)

• – upper respiratory tract infections, with symptoms such as sore throat and runny nose

• – injection-related reactions, such as fever, headache, muscle pain, chills and tiredness – these

usually occur in the 24 hours after an injection of Kesimpta, in particular after the first injection – urinary tract infections

• – injection-site reactions, such as redness, pain, itching and swelling at the injection site

Common (may affect up to 1 in 10 people)

• – decrease in the blood level of a protein called immunoglobulin M, which helps protect against

infection

• – oral herpes

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

5. How to store Kesimpta

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

Keep the pre-filled syringe(s) in the outer carton in order to protect from light. Store in a refrigerator (2°C – 8°C). Do not freeze.

Do not use this medicine if you notice that the solution contains visible particules or is cloudy.

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 Kesimpta contains

• – The active substance is ofatumumab. Each pre-filled syringe contains 20 mg ofatumumab.

• – The other ingredients are L-arginine, sodium acetate trihydrate, sodium chloride, polysorbate 80,

disodium edetate dihydrate, hydrochloric acid (for pH adjustment) and water for injections.

What Kesimpta looks like and contents of the pack

Kesimpta solution for injection is clear to slightly opalescent, and colourless to slightly brownish-yellow.

Kesimpta is available in unit packs containing 1 pre-filled syringe and in multipacks comprising

3 cartons, each containing 1 pre-filled syringe.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Ireland Limited

Vista Building

Elm Park, Merrion Road

Ballsbridge

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Farmacéutica SA

Ronda de Santa Maria 158

08210 Barbera del Vallès, Barcelona

Spain

For any information about this medicine, please

Authorisation Holder:

België/Belgiqu­e/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Efc^rapufl

Novartis Bulgaria EOOD

Ten.: +359 2 489 98 28

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Deutschland

Novartis Pharma Vertriebs GmbH

Tel: +49 911 273 0

Eesti

SIA Novartis Baltics Eesti filiaal

Tel: +372 66 30 810

EXÀàôa

Novartis (Hellas) A.E.B.E.

Tql: +30 210 281 17 12

España

Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00

France

Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00

Hrvatska

Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220

Ireland

Novartis Ireland Limited

Tel: +353 1 260 12 55

Ísland

Vistor hf.

Sími: +354 535 7000

Italia

Novartis Farma S.p.A.

Tel: +39 02 96 54 1

contact the local representative of the Marketing

Lietuva

SIA Novartis Baltics Lietuvos filialas

Tel: +370 5 269 16 50

Luxembourg/Lu­xemburg

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Magyarország

Novartis Hungária Kft.

Tel.: +36 1 457 65 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2122 2872

Nederland

Novartis Pharma B.V.

Tel: +31 88 04 52 111

Norge

Novartis Norge AS

Tlf: +47 23 05 20 00

Österreich

Novartis Pharma GmbH

Tel: +43 1 86 6570

Polska

Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888

Portugal

Novartis Farma – Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600

România

Novartis Pharma Services Romania SRL

Tel: +40 21 31299 01

Slovenija

Novartis Pharma Services Inc.

Tel: +386 1 300 75 50

Slovenská republika

Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

Kûnpoç

Novartis Pharma Services Inc.

Tql: +357 22 690 690

Sverige

Novartis Sverige AB

Tel: +46 8 732 32 00

Latvija

SIA Novartis Baltics

Tel: +371 67 887 070

United Kingdom (Northern Ireland)

Novartis Ireland Limited

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

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

.

Instructions for use of Kesimpta pre-filled syringe

It is important that you understand and follow these instructions for use before injecting Kesimpta. Talk to your doctor, pharmacist or nurse if you have any questions before you use Kesimpta for the first time.

Remember:

• Do not use the Kesimpta pre-filled syringe if either the seal on the outer carton or the seal of the

blister is broken. Keep the Kesimpta pre-filled syringe in the sealed carton until you are ready to use it.

• Do not shake the Kesimpta pre-filled syringe.
• The pre-filled syringe has a needle guard that will automatically cover the needle after the

injection is finished. The needle guard helps to prevent needlestick injuries to anyone who handles the pre-filled syringe after injection.

• Do not remove the needle cap until just before you give the injection.
• Avoid touching the syringe guard wings before use. Touching them may cause the needle guard

to cover the needle too early.

• Dispose of the used Kesimpta pre-filled syringe immediately after use. Do not re-use a

Kesimpta pre-filled syringe. See “How should I dispose of the used Kesimpta pre-filled syringe?” at the end of these Instructions for Use.

How should I store Kesimpta?

• Store the Kesimpta pre-filled syringe carton in a refrigerator between 2°C and 8°C.
• Keep the Kesimpta pre-filled syringe in the original carton until ready to use to protect from

light.

• Do not freeze the Kesimpta pre-filled syringe.

Keep Kesimpta out of the sight and reach of children.

Kesimpta pre-filled syringe parts (see Picture A):

What you need for your injection:

Included in the carton:

• A new Kesimpta pre-filled syringe

Not included in the carton (see Picture B ):

• 1 alcohol wipe
• 1 cotton ball or gauze
• Sharps disposal container

See “How should I dispose of the used Kesimpta pre-filled syringe?” at the end of these Instructions for Use.

Prepare the Kesimpta pre-filled syringe

Step 1. Find a clean, well-lit, flat work surface.

Step 2. Take the carton containing the Kesimpta pre-filled syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes so that it reaches room temperature.

Step 3. Wash your hands well with soap and water.

Step 4. Remove the pre-filled syringe from the outer carton and take it out of the blister by holding the syringe guard body.

Step 5. Look through the viewing window on the pre-filled syringe. The liquid inside should be clear to slightly opalescent. You may see a small air bubble in the liquid, which is normal. Do not use the pre-filled syringe if the liquid contains visible particles or is cloudy.

Step 6. Do not use the pre-filled syringe if it is damaged. Return the pre-filled syringe and the package it came in to the pharmacy.

Step 7. Do not use the pre-filled syringe if the expiry date has passed (see Picture C ). Return the expired pre-filled syringe and its packaging to the pharmacy.

Choose and clean the injection site

• Areas of your body that you can use for injecting Kesimpta include:
• the front of your thighs (see Picture D)
• the lower stomach area (abdomen), but not the area

5 cm around your navel (belly button) (see Picture D )

• your upper outer arms, if a caregiver or healthcare

professional is giving you the injection (see Picture E ).

• Choose a different site each time you inject Kesimpta.
• Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks or infection sites.

Step 8. Using a circular motion, clean the injection site with the alcohol wipe. Leave it to dry before injecting. Do not touch the cleaned area again before injecting.

Giving your injection

Step 9. Carefully remove the needle cap from the pre-filled syringe (see Picture F ). Throw away the needle cap. You may see a drop of liquid at the end of the needle. This is normal.

Step 10. With one hand, gently pinch the skin at the injection site. With your other hand insert the needle into your skin as shown (see Picture G ). Push the needle all the way in to make sure that you inject your full dose.

Step 11. Hold the pre-filled syringe finger grips as shown (see Picture H ). Slowly press down on the plunger as far as it will go, so that the plunger head is completely between the syringe guard wings.

Step 12. Continue to press fully on the plunger for 5 seconds while holding the syringe in place.

Step 13. Slowly release the plunger until the needle is covered (see Picture I ), and then remove the syringe from the injection site.

Step 14. There may be a little blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive plaster, if the bleeding continues.

How should I dispose of the used Kesimpta pre-filled syringe?

Step 15. Dispose of your used pre-filled syringe in a sharps disposal container (i.e. a puncture-resistant closable container, or similar) (see Picture J ).

• Do not dispose of your used pre-filled syringe in

your household waste.

• Never try to reuse your pre-filled syringe.

Keep the sharps container out of the reach of children.

Package leaflet: Information for the patient

Kesimpta 20 mg solution for injection in pre-filled pen ofatumumab

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.

• – Keep this leaflet. You may need to read it again.

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

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Kesimpta is and what it is used for

• 2. What you need to know before you use Kesimpta

• 3. How to use Kesimpta

• 4. Possible side effects

• 5. How to store Kesimpta

• 6. Contents of the pack and other information

1. What Kesimpta is and what it is used for

What Kesimpta is

Kesimpta contains the active substance ofatumumab. Ofatumumab belongs to a group of medicines called monoclonal antibodies.

What Kesimpta is used for

Kesimpta is used to treat adults with relapsing forms of multiple sclerosis (RMS).

How Kesimpta works

Kesimpta works by attaching to a target called CD20 on the surface of B cells. B cells are a type of white blood cell which are part of the immune system (the body’s defences). In multiple sclerosis, the immune system attacks the protective layer around nerve cells. B cells are involved in this process. Kesimpta targets and removes the B cells and thereby reduces the chance of a relapse, relieves symptoms and slows down the progression of the disease.

2. What you need to know before you use Kesimpta

Do not use Kesimpta

• – if you are allergic to ofatumumab or any of the other ingredients of this medicine (listed in

section 6).

• – if you have been told that you have severe problems with your immune system.

• – if you are suffering from a severe infection.

• – if you have cancer.

Warnings and precautions

Talk to your doctor before using Kesimpta

• – Kesimpta may cause the hepatitis B virus to become active again. Your doctor will perform a

blood test to check if you are at risk of hepatitis B infection. If this shows that you have had hepatitis B or are a carrier of the hepatitis B virus, your doctor will ask you to see a specialist.

• – Before you start treatment with Kesimpta, your doctor may check your immune system.

• – If you have an infection, your doctor may decide that you cannot be given Kesimpta or may

delay your treatment with Kesimpta until the infection is resolved.

• – Your doctor will check if you need any vaccinations before you start your treatment with

Kesimpta. If you need a type of vaccine called a live or live-attenuated vaccine, it should be given at least 4 weeks before you start Kesimpta treatment. Other types of vaccines should be given at least 2 weeks before you start Kesimpta treatment.

While using Kesimpta

Tell your doctor:

• – if you have a general injection-related reaction or a local injection-site reaction. These are the

most common side effects of Kesimpta treatment and are described in section 4. They usually occur in the 24 hours after Kesimpta is injected, in particular after the first injection. The first injection should take place under the guidance of a healthcare professional.

• – if you have an infection. You may get infections more easily or an infection you already have

may get worse. This is because the immune cells that Kesimpta targets also help to fight infection. Infections could be serious and sometimes even life-threatening.

• – if you plan to have any vaccinations. Your doctor will tell you whether the vaccination you need

is a live vaccine, a live-attenuated vaccine, or another type of vaccine. You should not be given live or live-attenuated vaccines during treatment with Kesimpta as this may result in infection. Other types of vaccines may work less well if they are given during treatment with Kesimpta.

Tell your doctor straight away if you get any of the following during your treatment with Kesimpta, because they could be signs of a serious condition:

• – if you think your multiple sclerosis is getting worse (e.g. weakness or visual changes) or if you

notice any new or unusual symptoms. These effects may indicate a rare brain disorder called progressive multifocal leukoencephalopathy (PML), which is caused by a virus infection.

Children and adolescents

Do not give this medicine to children and adolescents below 18 years of age because Kesimpta has not yet been studied in this age group.

Other medicines and Kesimpta

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist:

• – if you are taking, have recently taken or might take medicines that affect the immune system.

This is because these may have an added effect on the immune system.

• – if you plan to have any vaccinations (see “Warnings and Precautions” above).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy

You should avoid becoming pregnant while using Kesimpta and for 6 months after you stop using it.

If there is a possibility that you could become pregnant you should use an effective birth control method during treatment and for 6 months after stopping Kesimpta. Ask your doctor about the available options.

If you do become pregnant or think you may be pregnant during treatment or within 6 months after the last dose, tell your doctor straight away. Your doctor will discuss with you the potential risks of Kesimpta on pregnancy. This is because Kesimpta can reduce the number of immune cells (B cells) in both the mother and the unborn baby. Your doctor should report your pregnancy to Novartis. You can also report your pregnancy by contacting the local representative of Novartis (see section 6), in addition to contacting your doctor.

Breast-feeding

Kesimpta can pass into breast milk. Talk to your doctor about the benefits and risks before breast-feeding your baby while using Kesimpta.

Vaccination of newborn babies

Ask your doctor or pharmacist for advice before vaccinating your newborn baby if you have used Kesimpta during your pregnancy (see “Warnings and precautions” above).

Driving and using machines

Kesimpta is unlikely to affect your ability to drive and use machines.

Kesimpta contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How to use Kesimpta

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Kesimpta is given by subcutaneous injection (injection under your skin).

The first injection should take place under the guidance of a healthcare professional.

Kesimpta pre-filled pens are for single use only.

For detailed instructions on how to inject Kesimpta, see “Instructions for use of Kesimpta Sensoready Pen” at the end of this leaflet.

‘QR code to be included’ +

You can use Kesimpta at any time of day (morning, afternoon or evening).

How much Kesimpta to use and how often to use it

Do not exceed the dose prescribed by your doctor.

• – The initial dosing is 20 mg Kesimpta administered on the first day of treatment (Week 0) and

after 1 and 2 weeks (Week 1 and Week 2). After these first 3 injections, there is no injection in the following week (Week 3).

• – Starting at Week 4 and then every month, the recommended dose is 20 mg Kesimpta.

  Time	Dose
  Week 0 (first day of treatment)	20 mg
  Week 1	20 mg
  Week 2	20 mg
  Week 3	No injection
  Week 4	20 mg
  Every month afterwards	20 mg

How long to use Kesimpta

Continue using Kesimpta every month for as long as your doctor tells you to.

Your doctor will regularly check your condition to determine whether the treatment is having the desired effect.

If you have questions about how long to use Kesimpta, talk to your doctor, pharmacist or nurse.

If you use more Kesimpta than you should

If you have injected too much Kesimpta, contact your doctor right away.

If you forget to use Kesimpta

To get the full benefit of Kesimpta, it is important that you have every injection on time.

If you have forgotten an injection of Kesimpta, inject yourself as soon as possible. Do not wait until the next scheduled dose. The timing of future injections should then be calculated from the day you injected this dose and not based on the original schedule (see also “How much Kesimpta to use and how often to use it” above).

If you stop using Kesimpta

Do not stop using Kesimpta or change your dose without talking with your doctor.

Some side effects can be related to a low level of B cells in your blood. After you stop treatment with Kesimpta your blood level of B cells will gradually increase to normal. This can take several months. During this time some side effects described in this leaflet may still occur.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects of Kesimpta are listed below. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse.

Very common (may affect more than 1 in 10 people)

• – upper respiratory tract infections, with symptoms such as sore throat and runny nose

• – injection-related reactions, such as fever, headache, muscle pain, chills and tiredness – these

usually occur in the 24 hours after an injection of Kesimpta, in particular after the first injection – urinary tract infections

• – injection-site reactions, such as redness, pain, itching and swelling at the injection site

Common (may affect up to 1 in 10 people)

• – decrease in the blood level of a protein called immunoglobulin M, which helps protect against

infection

• – oral herpes

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

5. How to store Kesimpta

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

Keep the pre-filled pen(s) in the outer carton in order to protect from light. Store in a refrigerator (2°C – 8°C). Do not freeze.

Do not use this medicine if you notice that the solution contains visible particules or is cloudy.

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 Kesimpta contains

• – The active substance is ofatumumab. Each pre-filled pen contains 20 mg ofatumumab.

• – The other ingredients are L-arginine, sodium acetate trihydrate, sodium chloride, polysorbate 80,

disodium edetate dihydrate, hydrochloric acid (for pH adjustment) and water for injections.

What Kesimpta looks like and contents of the pack

Kesimpta solution for injection is clear to slightly opalescent, and colourless to slightly brownish-yellow.

Kesimpta is available in unit packs containing 1 pre-filled Sensoready Pen and in multipacks comprising 3 cartons, each containing 1 pre-filled Sensoready Pen.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Ireland Limited

Vista Building

Elm Park, Merrion Road

Ballsbridge

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Farmacéutica SA

Ronda de Santa Maria 158

08210 Barbera del Vallès, Barcelona

Spain

For any information about this medicine, please

Authorisation Holder:

België/Belgiqu­e/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Efc^rapufl

Novartis Bulgaria EOOD

Ten.: +359 2 489 98 28

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Deutschland

Novartis Pharma Vertriebs GmbH

Tel: +49 911 273 0

Eesti

SIA Novartis Baltics Eesti filiaal

Tel: +372 66 30 810

EXÀàôa

Novartis (Hellas) A.E.B.E.

Tql: +30 210 281 17 12

España

Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00

France

Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00

Hrvatska

Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220

Ireland

Novartis Ireland Limited

Tel: +353 1 260 12 55

Ísland

Vistor hf.

Sími: +354 535 7000

Italia

Novartis Farma S.p.A.

Tel: +39 02 96 54 1

contact the local representative of the Marketing

Lietuva

SIA Novartis Baltics Lietuvos filialas

Tel: +370 5 269 16 50

Luxembourg/Lu­xemburg

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Magyarország

Novartis Hungária Kft.

Tel.: +36 1 457 65 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2122 2872

Nederland

Novartis Pharma B.V.

Tel: +31 88 04 52 111

Norge

Novartis Norge AS

Tlf: +47 23 05 20 00

Österreich

Novartis Pharma GmbH

Tel: +43 1 86 6570

Polska

Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888

Portugal

Novartis Farma – Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600

România

Novartis Pharma Services Romania SRL

Tel: +40 21 31299 01

Slovenija

Novartis Pharma Services Inc.

Tel: +386 1 300 75 50

Slovenská republika

Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

Kûnpoç

Novartis Pharma Services Inc.

Tql: +357 22 690 690

Sverige

Novartis Sverige AB

Tel: +46 8 732 32 00

Latvija

SIA Novartis Baltics

Tel: +371 67 887 070

United Kingdom (Northern Ireland)

Novartis Ireland Limited

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

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

.

Instructions for use of Kesimpta Sensoready Pen

It is important that you understand and follow these instructions for use before injecting Kesimpta. Talk to your doctor, pharmacist or nurse if you have any questions before you use Kesimpta for the first time.

Remember:

• Do not use the pen if either the seal on the outer carton or the seal on the pen is broken. Keep

the pen in the sealed outer carton until you are ready to use it.

• Do not shake the pen.
• If you drop your pen, do not use it if the pen looks damaged, or if you dropped it with the cap

removed.

• Dispose of the used pen immediately after use. Do not re-use a pen. See “How should I dispose

of the used Kesimpta Sensoready Pen?” at the end of these Instructions for Use.

How should I store Kesimpta?

• Store the pen carton in a refrigerator between 2°C and 8°C.
• Keep the pen in the original carton until ready to use to protect from light.
• Do not freeze the pen.

Keep Kesimpta out of the sight and reach of children.

Kesimpta Sensoready Pen parts (see Picture A):

The Kesimpta Sensoready Pen is shown with the cap removed. Do not remove the cap until you are ready to inject.

What you need for your injection:

Included in the carton:

• A new Kesimpta Sensoready Pen (see

Picture B )

Not included in the carton (see Picture C ):

• 1 alcohol wipe
• 1 cotton ball or gauze
• Sharps disposal container

See “How should I dispose of the used Kesimpta Sensoready Pen?” at the end of these Instructions for Use.

Before your injection:

Take the pen out of the refrigerator 15 to 30 minutes before injecting to allow it to reach room temperature.

Step 1. Important safety checks before you inject

(see Picture D):

• Look through the viewing window. The liquid

should be clear to slightly opalescent.

Do not use if the liquid contains visible particles or is cloudy.

You may see a small air bubble, which is normal.

• Look at the expiry date (EXP) on your pen.

Do not use your pen if the expiry date has passed.

Contact your pharmacist or healthcare professional if your pen fails any of these checks.

Step 2. Choose your injection site:

• The recommended site is the front of the

thighs. You may also use the lower stomach area (lower abdomen), but not the area 5 cm around your navel (belly button) (see Picture E ).

• Choose a different site each time you inject

Kesimpta.

• Do not inject into areas where the skin is

tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks or infection sites.

Picture F

(caregiver and healthcare professional only)

Step 3. Clean your injection site:

• Wash your hands with soap and water.
• Using a circular motion, clean the injection site

with the alcohol wipe. Leave it to dry before injecting (see Picture G ).

• Do not touch the cleaned area again before

injecting.

Your injection

Step 4. Remove the cap:

• Only remove the cap when you are ready to

use the pen.

• Twist off the cap in the direction of the arrow

(see Picture H ).

• Throw away the cap. Do not try to re-attach

the cap.

• Use the pen within 5 minutes of removing the

cap.

You may see a few drops of medicine come out of the needle. This is normal.

Step 5. Hold your pen:

• Hold the pen at 90 degrees to the cleaned

injection site (see Picture I ).

Correct Incorrect

Important: During the injection you will hear 2 loud clicks :

• The first click indicates that the injection has started.
• The second click indicates that the injection is almost complete.

You must keep holding the pen firmly against your skin until the green indicator fills the window and stops moving.

Step 6. Start your injection:

• Press the pen firmly against your skin to start

the injection (see Picture J ).

• The first click indicates that the injection has

started.

• Keep holding the pen firmly against your skin.
• The green indicator shows the progress of the

injection.

Step 7. Complete your injection:

• Listen for the second click. This indicates that

the injection is almost complete.

• Check if the green indicator fills the window

and has stopped moving (see Picture K ).

• You can now remove the pen (see Picture L).

After your injection:

• If the green indicator does not fill the window,

this means you have not received the full dose. Contact your doctor or pharmacist if the green indicator is not visible.

• There may be a small amount of blood at the

injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive plaster, if the bleeding continues.

How should I dispose of the used Kesimpta Sensoready Pen?

Step 8. Dispose of your Kesimpta Sensoready Pen:

• Dispose of the used pen in a sharps disposal

container (i.e. a puncture-resistant closable container, or similar) (see Picture M ).

• Never try to re-use your pen.