KESIMPTA 20 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN - patient leaflet, side effects, dosage

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.

– Starting at Week 4 and then every month, the recommended dose is

20 mg Kesimpta.

Time _____________­_______

Week 0 (first day of treatment)

Week 1 ___________________

Week 2 __________________

Week 3 __________________

Week 4 _________________

Every month afterwards

Dose

20 mg

20 mg

20 mg No injection

20 mg

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.

– 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.

This leaflet was last revised in 06/2021

What Kesimpta is

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

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’.

1973569_GB_p1_LFT_X-4.indd 1

1 of 1

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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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):

Picture A

Needle

Needle guard

Cap---—=

} L Viewing window

Internal needle cover

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 )

Picture B

Picture C

• If a caregiver or healthcare professional is giving you your injection, they may also inject into your upper outer arm (see Picture F).

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).

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.

-S-

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.

Incorrect

Correct

Picture D

Viewing window

Picture E

Picture F (caregiver and healthcare professional only)

Picture G

Picture H

Picture I

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).

Picture J

Picture K

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.

Keep the sharps container out of the reach of children.

69SSZ6L

Nllll III

1973569

Picture M

1973569 GB

11/06/21 7:33 PM