KESIMPTA 20 mg Инъекционный Раствор

Содержание инструкции

1. Kesimpta 20 mg injectable solution in pre-filled syringe
   1. What is Kesimpta and what is it 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. Content of the pack and other information
2. Kesimpta 20 mg solution for injection in pre-filled pen
   1. What is Kesimpta and what is it 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. Content of the pack and other information

Kesimpta 20 mg injectable solution in pre-filled syringe

ofatumumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 is Kesimpta and what is it used for

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

What is Kesimpta used for
Kesimpta is used to treat adults with relapsing forms of multiple sclerosis (MS).

How does Kesimpta work
Kesimpta works by binding to a target called CD20 present on the surface of B cells.
B cells are a type of white blood cell (leukocyte) that is part of the immune system (the body's defenses). In multiple sclerosis, the immune system attacks the protective layer around nerve cells. B cells are involved in this process.
Kesimpta targets and removes B cells and therefore reduces the possibility of a relapse, relieves
symptoms and slows 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 you have a serious problem with your immune system
• if you have a severe infection
• if you have cancer.

Warnings and precautions
Talk to your doctor before using Kesimpta

• Kesimpta can cause reactivation of hepatitis B virus. Your doctor will test your blood to check if you are at risk of having a 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 consult a specialist.
• Before starting 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 treatment with Kesimpta until the infection has resolved.
• Your doctor will check if you need vaccinations before starting treatment with Kesimpta. If you need a type of vaccine called a live or live-attenuated vaccine, this must be given at least 4 weeks before starting treatment with Kesimpta. Other types of vaccines must be given at least 2 weeks before starting treatment with Kesimpta.

While you are using Kesimpta
Talk to your doctor:

• if you have a general reaction related to the injection or a local reaction at the injection site. These are the most common side effects of treatment with Kesimpta and are described in section 4. They usually occur within 24 hours after Kesimpta is injected, especially after the first injection. The first injection should be given under the guidance of a healthcare professional
• if you have an infection. You may be more likely to catch an infection or an infection you already have may worsen. This is because the immune cells that are targeted by Kesimpta also help to fight infection. Infections can be serious and sometimes life-threatening
• if you are planning to get vaccinated. Your doctor will tell you if the vaccination you need will be with a live vaccine, a live-attenuated vaccine, or another type of vaccine. Live or attenuated vaccines should not be given to you during treatment with Kesimpta as this can cause infection. Other types of vaccines may be less effective if given during treatment with Kesimpta.

Contact your doctor immediately if any of the following symptoms occur during treatment
with Kesimpta, as they may be signs of a serious condition:

• if you have a rash, hives, difficulty breathing, swelling of the face, eyelids, lips, mouth, tongue or throat, tightness in the chest or feeling faint. These could be signs or symptoms of an allergic reaction.
• if you think your multiple sclerosis is getting worse (e.g. weakness or changes in vision) or if you notice new or unusual symptoms. These effects may indicate a rare brain disease caused by a viral infection called progressive multifocal leukoencephalopathy (PML).

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age as
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 because these may have an additive effect on the immune system
• if you are planning to get vaccinated (see above "Warnings and precautions")

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before taking this medicine.
Pregnancy
You should avoid becoming pregnant while using Kesimpta and for 6 months after you have stopped
using it.
If there is a possibility that you may become pregnant, you should use effective contraceptive measures
during treatment with Kesimpta and for 6 months after stopping. Talk to your doctor about the
options available.
If you become pregnant or think you may be pregnant during treatment or within 6 months after
the last dose, tell your doctor immediately. The doctor will discuss with you the potential risks of
Kesimpta in pregnancy. This is because Kesimpta can reduce the number of immune cells (B cells)
in both the mother and the unborn child. The doctor must report the pregnancy to Novartis. You can also
report the pregnancy by contacting your local Novartis representative (see section 6), as well as
contacting your doctor.
Breastfeeding
Kesimpta can pass into breast milk. Ask your doctor for advice before breastfeeding your baby during
the use of Kesimpta.
Vaccination of infants
Ask your doctor or pharmacist for advice before vaccinating your newborn if you have used Kesimpta
during pregnancy (see "Warnings and precautions" above).

Driving and using machines
It is unlikely that Kesimpta will affect your ability to drive and operate machines.

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

3. How to use Kesimpta

Use this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
Kesimpta is administered via subcutaneous injection (injection under the skin).
The first injection must be performed under the guidance of a healthcare professional.
The prefilled syringes of Kesimpta are for single use only.
For detailed instructions on how to inject Kesimpta, see "Instructions for use of Kesimpta
prefilled syringe" at the end of this leaflet.
‘QR Code to be included’ + www.kesimpta.eu
You can use Kesimpta at any time of the 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 dosage is 20 mg of Kesimpta administered on the first day of treatment (Week 0) and then at Weeks 1 and 2. After these first 3 injections, an injection is not planned for the following week (Week 3).
• Starting from Week 4 and then every month, the recommended dose is 20 mg of Kesimpta.

How long to use Kesimpta
Continue to use Kesimpta every month for as long as your doctor tells you to.
Your doctor will regularly check your condition to determine if the treatment is having
the desired effect.
If you have any questions about how long to use Kesimpta, talk to your doctor, pharmacist or nurse.

If you use more Kesimpta than you should
If too much Kesimpta is injected, contact your doctor immediately.

If you forget to use Kesimpta
To get the full benefit of Kesimpta, it is important that you administer each injection
on time.
If you have forgotten an injection of Kesimpta, administer it as soon as possible. Do not wait
for the next planned dose. The intervals for subsequent injections should then be calculated
from the day you administer this injection and not based on the original schedule (see also
"How much Kesimpta to use and how often to use it").

If you stop using Kesimpta
Do not stop using Kesimpta and do not change the dose without talking to your doctor.
Some undesirable effects may be related to a low level of B cells in the blood. After
stopping treatment with Kesimpta, the level of B cells in the blood will gradually increase
to normal. This may take several months. During this period, some 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 become severe, tell your doctor, pharmacist or nurse.

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

• upper respiratory tract infection, with symptoms such as sore throat and runny nose
• injection-related reactions, such as fever, headache, muscle pain, chills and fatigue
• these reactions usually occur within 24 hours of the Kesimpta injection, particularly after the first injection
• urinary tract infections
• reactions at the injection site, 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 infections
• oral herpes
• nausea, vomiting (have been reported in association with injection-related reactions)

Not known(frequency cannot be estimated from available data)

• allergic reactions with symptoms such as skin rash, hives, difficulty breathing, swelling of the face, eyelids, lips, mouth, tongue or throat, tightness in the chest or feeling faint

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 package and label after
Exp. The expiry date refers to the last day of that month.
Store the pre-filled syringe (the pre-filled syringes) in the original packaging to protect the
medicine from light. Store in a refrigerator (2 °C – 8 °C). Do not freeze.
If necessary, Kesimpta can be left out of the refrigerator for a single period of up to 7 days at
room temperature (not exceeding 30°C). If not used during this period, Kesimpta can
then be returned to the refrigerator for a maximum of 7 days.
Do not use this medicine if you notice that the solution contains visible particles or is cloudy.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Kesimpta contains

• The active substance is ofatumumab. Each pre-filled syringe contains 20 mg of ofatumumab.
• The other components are L-arginine, sodium acetate trihydrate, sodium chloride, polysorbate 80, disodium edetate dihydrate, hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Kesimpta and contents of the pack
The injectable solution of Kesimpta is from clear to slightly opalescent, from colourless to
slightly yellow-brownish.
Kesimpta is available in single packs containing 1 pre-filled syringe and in multiple packs
consisting of 3 boxes, each containing 1 pre-filled syringe.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu

Instructions for use of the Kesimpta pre-filled syringe
Before injecting Kesimpta it is important to understand and follow these instructions for use. If you have
any doubts, ask your doctor, pharmacist or nurse before using Kesimpta for the first
time.

Remember to:

• do not usethe Kesimpta pre-filled syringe if the seal on the outer box or the blister seal is damaged. Keep the Kesimpta pre-filled syringe in the sealed box until you are ready to use it
• do not shakethe Kesimpta pre-filled syringe
• the pre-filled syringe has a needle protection device that automatically covers the needle after the medicine is injected. The protection device is designed to help protect against accidental needle stick injuries to anyone handling the pre-filled syringe after the injection
• do not remove the needle protective cap until you are ready to inject
• be careful not to touch the safety wings of the syringe before use. Touching them may cause the needle protection device to cover the needle prematurely.
• Do not use if the pre-filled syringe has fallen onto a hard surface or has fallen after removing the needle cap.
• Dispose of the Kesimpta pre-filled syringe immediately after use. Do not reuse theKesimpta pre-filled syringe. See “How to dispose of the Kesimpta pre-filled syringe after use” at the end of these Instructions for Use.

How to store Kesimpta

• Store the pack of the Kesimpta pre-filled syringe in a refrigerator at a temperature between 2 °C and 8 °C.
• Keep the Kesimpta pre-filled syringe in the original pack until use to protect it from light.
• Do not freezethe Kesimpta pre-filled syringe.

Keep Kesimpta out of the sight and reach of children.
Components of the Kesimpta pre-filled syringe (see Figure A):
Figure A

What you need for the injection
Included in the box:

• one new Kesimpta pre-filled syringe

Not included in the box ( see Figure B):

• 1 alcohol swab
• 1 cotton ball or gauze
• sharps container

See “How to dispose of the Kesimpta pre-filled syringe
after use” at the end of these Instructions for Use.

Figure B

Preparing the Kesimpta pre-filled syringe
Step 1. Find a clean and well-lit work surface.
Step 2. Remove the pack containing the Kesimpta pre-filled syringe from the refrigerator and
leave it closedfor about 15-30 minutes on the work surface to allow it to reach room
temperature.
Step 3. Wash your hands thoroughly with soap and water.
Step 4. Remove the pre-filled syringe from the box and remove it from the blister by holding the
body of the syringe.
Step 5. Look through the viewing window on the pre-filled syringe. The
liquid inside should be from clear to slightly opalescent. Small air bubbles may be visible, this is normal. Do not usethe pre-filled syringe if the liquid
contains particles that are easily visible or is cloudy.
Step 6. Do not useif the syringe is damaged. Return the pre-filled syringe and the pack
containing it to your pharmacist.
Step 7. Do not usethe pre-filled syringe if it is
past the expiry date ( see Figure C).
Return the expired pre-filled syringe and
its pack to your pharmacist.

Figure C

Choose and clean the injection site

• The areas of the body you can use for the injection of Kesimpta include:
• the front of the thighs ( see Figure D)
• the lower abdomen (belly), excluding an area of 5 centimetres around the navel ( see Figure D)
• the upper outer area of the arms, if the injection is performed by someone assisting you or a healthcare professional ( see FigureE). Figure D

Figure E
(for someone assisting you or
healthcare professionals only)

• Choose a different site each time you inject Kesimpta.
• Do not injectinto areas where the skin is sensitive, bruised, red, flaky or hardened. Avoid areas where there are scars, stretch marks or infections.

Step 8. With a circular motion, clean the injection site with an alcohol swab.
Let it dry before injecting. Do not touch the cleaned area again
before injecting.

How to give the injection
Step 9. Carefully remove the protective
needle cap from the pre-filled syringe ( see
Figure F). Throw away the needle cap. A drop of liquid may come out of the tip of the needle.
This is normal.

Figure F

Step 10. Gently pinch the skin of the injection site with one hand. With the other hand, insert
the needle into the skin as illustrated ( see Figure G).
Push the needle in deeply to ensure that all the
medicine is given.

Figure G

Step 11. Hold the syringe as illustrated ( see
Figure H). Slowly push the plunger all the way in so that the plunger head is
completely between the wings of the syringe.
Step 12. Continue to hold the plunger pressed in for 5 seconds, keeping the syringe in
position.

Figure H

Step 13. Slowly release the plunger to
allow the syringe protection to cover the exposed
needle ( see Figure I), then remove the syringe
from the injection site.
Step 14. A little bleeding may occur at the injection site. If so, you can
press a cotton ball or gauze onto the injection site and hold it for 10 seconds. Do not rub the
injection site. If necessary, you can cover the
injection site with a small plaster, if the
bleeding continues.

Figure I

How to dispose of the Kesimpta pre-filled syringe after use
Step 15. Dispose of the used pre-filled
syringe by placing it in a sharps container
(a closable, puncture-resistant container or
similar) ( see Figure J).

• Do not dispose ofthe pre-filled syringe after use Figure J

in household waste.

• Used syringes should never be reused.

Keep the sharps container out of the
sight and reach of children.

Kesimpta 20 mg solution for injection in pre-filled pen

ofatumumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 is Kesimpta and what is it used for

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

What is Kesimpta used for
Kesimpta is used to treat adults with relapsing forms of multiple sclerosis (MS).

How does Kesimpta work
Kesimpta works by binding to a target called CD20 present on the surface of B cells.
B cells are a type of white blood cell (leukocytes) that are part of the
immune system (the body's defenses). In multiple sclerosis, the immune system attacks the protective layer
around nerve cells. B cells are involved in this process.
Kesimpta targets and removes B cells and therefore reduces the possibility of having a relapse, relieves
symptoms and slows 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 you have a serious problem with your immune system
• if you have a severe infection
• if you have cancer.

Warnings and precautions
Talk to your doctor before using Kesimpta

• Kesimpta can cause hepatitis B virus to become active again. Your doctor will test your blood to check if you are at risk of having a hepatitis B infection. If this shows that you have had hepatitis B or you are a carrier of the hepatitis B virus, your doctor will ask you to consult a specialist.
• Before starting 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 treatment with Kesimpta until the infection has resolved.
• Your doctor will check if you need vaccinations before starting treatment with Kesimpta. If you need a type of vaccine called a live or live-attenuated vaccine, this must be given at least 4 weeks before starting treatment with Kesimpta. Other types of vaccines must be given at least 2 weeks before starting treatment with Kesimpta.

While you use Kesimpta
Talk to your doctor:

• if you have a general reaction related to the injection or a local reaction at the injection site. These are the most common side effects of treatment with Kesimpta and are described in section 4. They usually occur within 24 hours after Kesimpta is injected, especially after the first injection. The first injection should be given under the guidance of a healthcare professional
• if you have an infection. You may be more likely to catch an infection or an infection you already have may worsen. This happens because the immune cells that are targeted by Kesimpta also help to fight infection. Infections can be serious and sometimes life-threatening
• if you are planning to have vaccinations. Your doctor will tell you if the vaccination you need will be with a live vaccine, a live-attenuated vaccine, or another type of vaccine. Live or attenuated vaccines should not be given to you while you are being treated with Kesimpta as this can cause an infection. Other types of vaccines may be less effective if given during treatment with Kesimpta.

Contact your doctor immediately if any of the following symptoms occur during treatment
with Kesimpta, because they may be signs of a serious condition:

• if you have a rash, hives, difficulty breathing, swelling of the face, eyelids, lips, mouth, tongue or throat, tightness in the chest or feeling faint. These could be signs or symptoms of an allergic reaction.
• if you think your multiple sclerosis is getting worse (e.g. weakness or changes in vision) or if you notice new or unusual symptoms. These effects may indicate a rare brain disease caused by a viral infection called progressive multifocal leukoencephalopathy (PML).

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age as
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 because these can have an additive effect on the immune system
• if you are planning to have vaccinations (see above "Warnings and precautions")

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
ask your doctor for advice before taking this medicine.
Pregnancy
You should avoid becoming pregnant while using Kesimpta and for 6 months after you have stopped
using it.
If there is a possibility that you may become pregnant you should use effective contraceptive measures
during treatment with Kesimpta and for 6 months after stopping. Talk to your doctor about the
options available.
If you become pregnant or think you may be pregnant during treatment or within 6 months after
the last dose, tell your doctor immediately. The doctor will discuss with you the potential risks of
Kesimpta in pregnancy. This is because Kesimpta can reduce the number of immune cells (B cells)
in both the mother and the unborn child. The doctor must report the pregnancy to Novartis. You can also
report the pregnancy by contacting your local Novartis representative (see section 6), as well as
contacting your doctor.
Breastfeeding
Kesimpta can pass into breast milk. Ask your doctor about the benefits and risks before
breastfeeding your baby while using Kesimpta.
Vaccination of infants
Ask your doctor or pharmacist for advice before vaccinating your newborn baby if you have used Kesimpta
during pregnancy (see "Warnings and precautions" above).

Driving and using machines
It is unlikely that Kesimpta will affect your ability to drive and use machines.

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

3. How to use Kesimpta

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any
doubts, ask your doctor or pharmacist.
Kesimpta is administered via subcutaneous injection (injection under the skin).
The first injection must be performed 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’ + www.kesimpta.eu
You can use Kesimpta at any time of the 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 dose is 20 mg of Kesimpta administered on the first day of treatment (Week 0) and then at Weeks 1 and 2. After these first 3 injections, an injection is not planned for the following week (Week 3).
• Starting from Week 4 and then every month, the recommended dose is 20 mg of Kesimpta.

How long to use Kesimpta
Continue to use Kesimpta every month for as long as indicated by your doctor.
Your doctor will regularly check your condition to determine if the treatment is having
the desired effect.
If you have any questions about how long to use Kesimpta, talk to your doctor, pharmacist or nurse.

If you use more Kesimpta than you should
If too much Kesimpta is injected, contact your doctor immediately.

If you forget to use Kesimpta
To get the full benefit of Kesimpta, it is important that you administer each injection
on time.
If you have forgotten an injection of Kesimpta, administer it as soon as possible. Do not wait
for the next scheduled dose. The intervals for subsequent injections must then be calculated
from the day you administer this injection and not based on the original schedule (see also
"How much Kesimpta to use and how often to use it").

If you stop using Kesimpta
Do not stop using Kesimpta and do not change the dose without talking to your doctor.
Some undesirable effects may be related to a low level of B cells in the blood. After
stopping treatment with Kesimpta, the level of B cells in the blood will gradually increase
to normal. This may take several months. During this period, some effects
described in this leaflet may still occur.
If you have any doubts about 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 become severe, tell your doctor, pharmacist or nurse.

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

• upper respiratory tract infection, with symptoms such as sore throat and runny nose
• injection-related reactions, such as fever, headache, muscle pain, chills and fatigue
• these reactions usually occur within 24 hours of the Kesimpta injection, especially after the first injection
• urinary tract infections
• reactions at the injection site, 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 infections
• oral herpes
• nausea, vomiting (have been reported in association with injection-related reactions)

Not known(frequency cannot be estimated from available data)

• allergic reactions with symptoms such as skin rash, hives, difficulty breathing, swelling of the face, eyelids, lips, mouth, tongue or throat, tightness in the chest or feeling faint

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 package and label after
Exp. The expiry date refers to the last day of that month.
Store the pre-filled pen (the pre-filled pens) in the original packaging to protect the
medicine from light. Store in a refrigerator (2 °C – 8 °C). Do not freeze.
If necessary, Kesimpta may be left out of the refrigerator for a single period of up to 7 days at
room temperature (not exceeding 30°C). If not used during this period, Kesimpta may
then be returned to the refrigerator for a maximum of 7 days.
Do not use this medicine if you notice that the solution contains visible particles or is cloudy.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Kesimpta contains

• The active substance is ofatumumab. Each pre-filled pen contains 20 mg of ofatumumab.
• The other components are L-arginine, sodium acetate trihydrate, sodium chloride, polysorbate 80, disodium edetate dihydrate, hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Kesimpta and content of the pack
The injectable solution of Kesimpta is from clear to slightly opalescent, from colourless to
slightly yellow-brownish.
Kesimpta is available in single packs containing 1 Sensoready pre-filled pen and in
multiple packs consisting of 3 boxes, each containing 1 Sensoready pre-filled pen.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu

Instructions for using the Kesimpta Sensoready pen
Before injecting Kesimpta it is important to understand and follow these instructions for use. If you
have any doubts, ask your doctor, pharmacist or nurse before using Kesimpta for the first
time.

Remember to:

• do not usethe pen if the seal on the outer box or the blister seal is damaged. Keep the pen in the sealed outer box until you are ready to use it
• do not shakethe pen
• ifyou drop the pen, do not use itif it appears damaged or if you dropped it without the cap
• dispose of the pen immediately after use. Do not reuse the pen. See “How to dispose of the Kesimpta Sensoready pen after use” at the end of these Instructions for Use.

How to store Kesimpta

• Store the pen packaged in a refrigerator at a temperature between 2 °C and 8 °C.
• Keep the pen in the original packaging until use to protect it from light.
• Do not freezethe pen.

Keep Kesimpta out of the sight and reach of children.
Components of the Kesimpta Sensoready pen (see Figure A):
Figure A

The Kesimpta Sensoready pen is shown with the cap removed. Do notremove the cap
until you are ready to inject.

What you need for the injection:
Included in the pack:

• one new Kesimpta Sensoready pen ( see Figure B) Figure B

Not included in the pack ( see Figure C):

• 1 alcohol swab
• 1 cotton ball or gauze
• sharps disposal container Figure C

See “How to dispose of the Kesimpta Sensoready Pen
after use” at the end of these
Instructions for Use.

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

Step 1. Important safety checks
before the injection (see Figure D)

• Look through the viewing window. The liquid should be clear or slightly opalescent. Do not useif the liquid contains particles that are easily visible or is cloudy. You may see some small air bubbles, this is normal.
• Check the expiry date (EXP)on the pen. Do not usethe pen after the expiry date. Figure D

Contact your pharmacist or healthcare professional if the
pen does not meet any of these requirements.

Step 2. Choosing the injection siteFigure E

• The recommended site is the front of the thighs. You can also use the lower abdomen, excluding an area of 5 centimetres around the navel ( see Figure E).
• Choose a different site for each new Kesimpta injection.
• Do not injectinto areas where the skin is sensitive, bruised, red, scaly or hardened. Avoid areas where there are scars or stretch marks or sites of infection.

• If the injection is given to you by a helperor a healthcare professional, it can also be done on the outer upper arms ( seeFigure F). Figure F(for helpers or healthcare professionals only)

Step 3. Cleaning the injection site

• Wash your hands with soap and water.
• Using a circular motion, clean the injection site with an alcohol swab. Allow to dry before injecting ( see Figure G).
• Do not touch the cleaned area again before injecting. Figure G

Your injection
Step 4. Removing the cap:

• Remove the cap only when you are ready to use the pen.
• Unscrew the cap in the direction of the arrows ( see Figure H).
• Once removed, discard the cap. Do not attempt to replace the cap.
• Use the pen within 5 minutes of removing the cap. A drop of liquid may come out of the needle tip. This is normal. Figure H

Step 5. Pen position:Figure I

• Hold the pen at a 90-degree angle to the cleaned injection site ( see Figure I).

Important:during the injectionyou will hear 2 clicks.

• The first clickindicates that the injection has started.
• The second clickindicates that the injection is almost complete. Continue to hold the pen firmly against the skin until a green indicatorfills the window and stops.

Step 6. Start the injection

• Press the pen firmly against the skin to start the injection ( see Figure J).
• The first clickindicates that the injection has started.
• Continue to holdthe pen firmly against the skin.
• The green indicatorshows the progress of the injection. Figure J

Step 7. Complete the injectionFigure K

• Wait for the sound of the second click. This indicates that the injection is almostcomplete.
• Check that the green indicatorhas filled the window and stopped ( seeFigure K).
• At this point you can remove the pen ( see Figure L).

Figure L

After your injection:

• If the green indicator does not fill the window, this means that the full dose has not been administered. 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 onto the injection site and hold it for 10 seconds. Do not rub the injection site. You can cover the injection site with a small adhesive bandage if the bleeding continues.

How to dispose of the Kesimpta Sensoready pen after use
Step 8. Dispose of the Kesimpta Sensoready pen

• Dispose of the used pen by placing it in a sharps container (e.g. a closable, puncture-resistant container or similar) ( see Figure M).
• Never attempt to reuse the pen.

Keep the sharps container out of
sight and reach of children
Figure M