Package leaflet: Information for the patient

Kesimpta 20 mg solution for injection in pre-filled syringe

ofatumumab
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Kesimpta is and what it is used for
What you need to know before using Kesimpta
How to use Kesimpta
Possible side effects
How to store Kesimpta
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 known as 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 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 defences). In multiple sclerosis, the immune system attacks the protective layer surrounding nerve cells. B cells are involved in this process.
Kesimpta targets and depletes B cells, thereby reducing the likelihood of relapses, relieving symptoms, and slowing disease progression.

2. What you need to know before using Kesimpta

Do not use Kesimpta

if you are allergic to ofatumumab or to any of the other ingredients of this medicine (listed in section 6)
if you have been informed that you have severe problems with your immune system
if you have a serious infection
if you have cancer.

Warnings and precautions
Talk to your doctor before using Kesimpta

Kesimpta may cause reactivation of hepatitis B virus. Your doctor will perform a blood test to check whether 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 consult a specialist.
Before starting treatment with Kesimpta, your doctor may check your immune system.
If you have an infection, your doctor may decide not to give you Kesimpta or may delay treatment with Kesimpta until the infection has resolved.
Your doctor will check whether you need vaccinations before starting treatment with Kesimpta. If you need a type of vaccine called a live or live-attenuated vaccine, it must be administered at least 4 weeks before starting treatment with Kesimpta. Other types of vaccines should be given at least 2 weeks before starting treatment with Kesimpta.

While using Kesimpta
Talk to your doctor:

if you experience a systemic 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, particularly after the first injection. The first injection must be given under the supervision of a healthcare professional.
if you have an infection. You may be more likely to get an infection, or an existing infection may worsen. This is because the immune cells targeted by Kesimpta also help fight infections. Infections may be serious and sometimes even life-threatening.
if you plan to receive vaccinations. Your doctor will inform you whether the vaccination you need is a live vaccine, a live-attenuated vaccine, or another type of vaccine. You must not receive live or attenuated vaccines during treatment with Kesimpta, as this could cause an infection. Other types of vaccines may be less effective if administered 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 develop a rash, hives, difficulty breathing, swelling of the face, eyelids, lips, mouth, tongue or throat, chest tightness, or a feeling of fainting. 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 administer 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, inform your doctor or pharmacist:

if you are taking, have recently taken, or might take medicines that affect the immune system, as these may have an additive effect on the immune system
if you plan to receive vaccinations (see above "Warnings and precautions")

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast milk, consult your doctor before taking this medicine.
Pregnancy
You should avoid becoming pregnant while using Kesimpta and for 6 months after stopping it.
If there is a possibility you could become pregnant, you must use effective contraception during treatment with Kesimpta and for 6 months after stopping it. Discuss available options with your doctor.
If you become pregnant or think you are pregnant during treatment or within 6 months after the last dose, inform your doctor immediately. Your doctor will discuss with you the potential risks of Kesimpta during pregnancy. This is because Kesimpta can reduce the number of immune cells (B cells) in both the mother and the unborn child. Your doctor must report the pregnancy to Novartis. You may also report the pregnancy by contacting the local Novartis representative (see section 6), in addition to informing your doctor.
Breastfeeding
Kesimpta may pass into breast milk. Talk to your doctor about the benefits and risks before breastfeeding your baby while using Kesimpta.
Vaccination of newborns
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 or use machinery.
Kesimpta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.
Kesimpta contains polysorbate 80
This medicine contains 0.08 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Kesimpta

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Kesimpta is administered by subcutaneous injection (an injection under the skin).
The first injection must be given under the supervision of a healthcare professional.
The Kesimpta pre-filled syringes are for single use only.
For detailed instructions on how to inject Kesimpta, see the "Instructions for Use of Kesimpta
Pre-filled Syringe" at the end of this leaflet.
‘QR code to be included’ + www.kesimpta.eu
Kesimpta may be used 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), followed by doses in Weeks 1 and 2 (Week 1 and Week 2). After these first three injections, no injection is scheduled for the following week (Week 3).
Starting from Week 4 and every month thereafter, the recommended dose is 20 mg of Kesimpta.

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

How long to use Kesimpta
Continue using Kesimpta every month for as long as your doctor has instructed.
Your doctor will regularly monitor your condition to determine whether the treatment is having the desired effect.
If you have any questions about how long to use Kesimpta, speak with your doctor, pharmacist, or nurse.

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

If you forget to use Kesimpta
To get the full benefit from Kesimpta, it is important that you administer each injection on time.
If you have forgotten an injection of Kesimpta, self-administer it as soon as possible. Do not wait for the next scheduled dose. The timing for subsequent injections should then be calculated from the day you administer this missed 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 or change the dose without talking to your doctor.
Some side effects may be related to low levels of B cells in the blood. After stopping treatment with Kesimpta, the level of B cells in the blood will gradually return to normal. This may take several months. During this period, some of the side effects described in this leaflet may still occur.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects of Kesimpta are listed below. If any of these side effects become severe, inform 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 after injection of Kesimpta, particularly 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 blood levels of a protein called immunoglobulin M, which helps protect against infections
oral herpes
nausea, vomiting (reported in association with injection-related reactions)

Not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to 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 stated on the carton and label after
Exp. The expiry date refers to the last day of that month.
Store the pre-filled syringe (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 may be kept out of the refrigerator for a single period of up to 7 days at
room temperature (not above 30 °C). If not used during this time, Kesimpta may then be returned to the refrigerator for up to 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 (E 433), disodium edetate dihydrate, hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Kesimpta and contents of the pack
Kesimpta injectable solution is from clear to slightly opalescent and from colourless to slightly yellowish-brown.
Kesimpta is available in single packs containing 1 pre-filled syringe and in multiple packs composed of 3 boxes, each containing 1 pre-filled syringe.
It is possible that not all pack sizes are 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 about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor ehf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicine 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, consult your doctor, pharmacist, or nurse before using Kesimpta for the first
time.
Remember to:

Do not use the Kesimpta pre-filled syringe if the seal on the outer carton or the blister seal is damaged. Keep the Kesimpta pre-filled syringe in its sealed carton until ready to use.
Do not shake the Kesimpta pre-filled syringe.
The pre-filled syringe has a needle safety guard that automatically covers the needle after injection of the medicine. The safety guard is designed to help protect from accidental needlestick injuries anyone handling the pre-filled syringe after injection.
Do not remove the needle protective cap until ready for injection.
Be careful not to touch the safety wings of the syringe before use. Touching them may cause the needle safety guard to cover the needle prematurely.
Do not use if the pre-filled syringe has fallen on a hard surface or has been dropped after removing the needle cap.
Dispose of the Kesimpta pre-filled syringe immediately after use. Do not reuse the Kesimpta 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 Kesimpta pre-filled syringe carton in the refrigerator at a temperature between 2 °C and 8 °C.
Keep the Kesimpta pre-filled syringe in its original packaging until use to protect it from light.
Do not freeze the 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

Technical diagram of a syringe with labels indicating the needle cap

No image was provided for analysis. Please upload the

What you need for the injection
Included in the box:

one new Kesimpta pre-filled syringe Figure B

A square adhesive bandage, a cotton ball, and a biohazard waste container separated by plus signs on a white background

Not included in the box ( see Figure B ):

1 alcohol swab
1 cotton ball or gauze pad
sharps disposal container

See “How to dispose of the Kesimpta pre-filled syringe
after use” at the end of these Instructions for Use.
Preparing the Kesimpta pre-filled syringe
Step 1. Find a clean, well-lit work surface.
Step 2. Remove the carton containing the Kesimpta pre-filled syringe from the refrigerator and
leave it closed on the work surface for approximately 15–30 minutes so it can reach room
temperature.
Step 3. Wash your hands thoroughly with soap and water.
Step 4. Remove the pre-filled syringe from the carton and take it out of the blister, holding the
body of the syringe.
Step 5. Look through the inspection window on the pre-filled syringe. The liquid inside should be
from clear to slightly opalescent. Small air bubbles may be visible, which is normal. Do not use the
pre-filled syringe if the liquid contains visible particles or is cloudy.
Step 6. Do not use if the syringe is damaged. Return the pre-filled syringe and its packaging to the
pharmacist.
Step 7. Do not use the pre-filled syringe if it is Figure C
past the expiration date ( see Figure C ).

Technical drawing of a horizontal syringe showing the expiration date with the label 'EXP' and a black reference line

Return the expired pre-filled syringe and its
packaging to the pharmacist.
Choosing and cleaning the injection site

Areas of the body you may use for Kesimpta injection include:
the front of the thighs ( see Figure D ) Figure D

Schematic drawing of a male torso with gray highlighted areas on the

the lower stomach (abdominal) area, excluding a 5-centimeter area around the navel ( see Figure D )
the upper outer arms, if the injection is administered by someone assisting you or by a healthcare professional ( see Figure E ).

Figure E
(only for use by someone assisting or healthcare
professionals)

Schematic drawing of the back of a human body with two gray highlighted areas on the arms and one gray area on the lower back

Choose a different injection site each time you administer a Kesimpta injection.
Do not inject into areas where the skin is tender, bruised, red, flaky, or hardened. Avoid areas with scars, stretch marks, or infections.

Step 8. Using a circular motion, clean the injection site with an alcohol swab. Allow it to dry before
administering the injection. Do not touch the cleaned area again before proceeding with the injection.
How to administer the injection
Step 9. Carefully remove the needle protective cap from the pre-filled syringe ( see Figure F ).
Figure F

Two hands holding a syringe to inject its contents into a cylindrical vial, with a black arrow indicating the withdrawal movement

Discard the needle cap. A drop of liquid may appear at the tip of the needle. This is normal.
Figure G
Step 10. Gently pinch the skin at the injection site with one hand. With the other hand, insert the
needle into the skin as illustrated ( see Figure G ).

Push the needle fully in to ensure all the medicine is delivered.
Figure H
Step 11. Hold the syringe as shown ( see Figure H ). Slowly push the plunger all the way down until
the plunger head is completely within the safety wings of the syringe.

Technical drawing showing two hands holding a medical device with a close-up detail of the tip and insertion mechanism

Step 12. Continue holding the plunger fully depressed for 5 seconds, keeping the syringe in place.
Figure I
Step 13. Slowly release the plunger to allow the syringe’s safety guard to cover the exposed needle
( see Figure I ), then remove the syringe from the injection site.

Technical drawing showing a hand holding a syringe-like medical device with a black arrow indicating downward movement

Step 14. Mild bleeding at the injection site may occur. If so, press a cotton ball or gauze pad over the
site and hold for 10 seconds. Do not rub the injection site. If needed, a small adhesive bandage may be
used if bleeding continues.

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

A hand holding a syringe above a biohazard waste container with the biohazard symbol for safe disposal

Do not dispose of the used pre-filled syringe in household waste.
Used syringes must never be reused.

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

Patient information leaflet

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

ofatumumab
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Kesimpta is and what it is used for
What you need to know before using Kesimpta
How to use Kesimpta
Possible side effects
How to store Kesimpta
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 known as 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 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 defences). In multiple sclerosis, the immune system attacks the protective layer surrounding nerve cells. B-cells are involved in this process.
Kesimpta targets and depletes B-cells, thereby reducing the likelihood of relapses, relieving symptoms, and slowing the progression of the disease.

2. What you should know before using Kesimpta

Do not use Kesimpta

if you are allergic to ofatumumab or to any of the other ingredients of this medicine (listed in section 6)
if you have been told that you have serious problems 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 may cause reactivation of hepatitis B virus. Your doctor will perform a blood test to check whether 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 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 whether you need vaccinations before starting treatment with Kesimpta. If you need a type of vaccine called a live or live-attenuated vaccine, it must be administered at least 4 weeks before starting treatment with Kesimpta. Other types of vaccines should be administered at least 2 weeks before starting Kesimpta treatment.

While using Kesimpta
Talk to your doctor:

if you experience a systemic 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 must be administered under the supervision of a healthcare professional.
if you have an infection. You may be more likely to get an infection, or an existing infection may worsen. This is because the immune cells targeted by Kesimpta also help fight infections. Infections can be serious and sometimes even life-threatening.
if you plan to receive vaccinations. Your doctor will inform you whether the vaccination you need is a live vaccine, a live-attenuated vaccine, or another type of vaccine. You must not receive live or attenuated vaccines during treatment with Kesimpta, as this could cause an infection. Other types of vaccines may be less effective if administered during treatment with Kesimpta.

Talk to your doctor immediately if you experience any of the following symptoms during treatment
with Kesimpta, as they may be signs of a serious condition:

if you develop a rash, hives, difficulty breathing, swelling of the face, eyelids, lips, mouth, tongue, or throat, chest tightness, or a feeling of fainting. These could be signs or symptoms of an allergic reaction.
if you think your multiple sclerosis is worsening (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 administer 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
In particular, inform your doctor or pharmacist:

if you are taking, have recently taken, or might take medicines that affect the immune system, as these may have an additive effect on the immune system
if you plan to receive vaccinations (see above "Warnings and precautions")

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding,
consult your doctor before taking this medicine.
Pregnancy
You must avoid becoming pregnant while using Kesimpta and for 6 months after stopping
treatment.
If there is a possibility you could become pregnant, you must use effective contraception
during treatment with Kesimpta and for 6 months after stopping treatment. Discuss available
options with your doctor.
If you become pregnant or think you are pregnant during treatment or within 6 months after
the last dose, inform your doctor immediately. Your doctor will discuss with you the potential risks of
Kesimpta during pregnancy. This is because Kesimpta can reduce the number of immune cells (B cells)
in both the mother and the unborn child. Your doctor must report the pregnancy to Novartis.
You may also report the pregnancy by contacting the local Novartis representative (see section 6), in addition to contacting your doctor.
Breastfeeding
Kesimpta may pass into breast milk. Talk to your doctor about the benefits and risks before
breastfeeding your baby while using Kesimpta.
Vaccination of newborns
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 or use machinery.
Kesimpta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.
Kesimpta contains polysorbate 80
This medicine contains 0.08 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Kesimpta

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Kesimpta is administered by subcutaneous injection (injection under the skin).
The first injection must be given under the supervision of a healthcare professional.
Kesimpta pre-filled pens are for single use only.
For detailed instructions on how to inject Kesimpta, see the "Instructions for Use for Kesimpta
Sensoready Pen" at the end of this leaflet.
‘QR Code to include’ + www.kesimpta.eu
Kesimpta can be used 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 dose is 20 mg of Kesimpta administered on the first day of treatment (Week 0), then in weeks 1 and 2 (Week 1 and Week 2). After these first 3 injections, no injection is scheduled for the following week (Week 3).
Starting in Week 4 and every month thereafter, the recommended dose is 20 mg of Kesimpta.

Time	Dose
Week 0 (first day of treatment)	20 mg
Week 1	20 mg
Week 2	20 mg
Week 3	No injection
Each subsequent month	20 mg

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

If you forget to use Kesimpta
To get the full benefit from Kesimpta, it is important that you administer each injection on time.
If you have missed an injection of Kesimpta, self-administer it as soon as possible. Do not wait for the next scheduled dose. The intervals for subsequent injections should then be calculated from the day you administer this missed injection, and not according to 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 or change the dose without talking to your doctor.
Some side effects may be related to low levels of B-cells in the blood. After stopping treatment with Kesimpta, the level of B-cells in the blood will gradually return to normal. This may take several months. During this period, some of the side effects described in this leaflet may still occur.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects of Kesimpta are listed below. If any of these side effects become severe, inform 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 fatigue
these reactions usually occur within 24 hours after a Kesimpta injection, especially 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 blood levels of a protein called immunoglobulin M, which helps protect against infections
oral herpes
nausea, vomiting (reported in association with injection-related reactions)

Not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, 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 stated on the carton and label after
Exp. The expiry date refers to the last day of that month.
Store the pre-filled pen (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 kept outside the refrigerator for a single period of up to 7 days at
room temperature (not above 30°C). If not used during this period, Kesimpta may
then be returned to the refrigerator for up to 7 days.
Do not use this medicine if you notice that the solution contains visible particles or is cloudy.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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 (E 433), disodium edetate dihydrate, hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Kesimpta and contents of the pack
Kesimpta injectable solution is from clear to slightly opalescent, from colourless to slightly yellow-brown.
Kesimpta is available in single packs containing 1 Sensoready pre-filled pen and in multiple packs composed 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: