Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - kesimpta

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Generated Narrative: MedicinalProductDefinition mp4c58d0c1d9c4a5073dfc9d3ac749320b

identifier: http://ema.europa.eu/identifier/EU/1/21/1532/001-004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Kesimpta 20 mg solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-4c58d0c1d9c4a5073dfc9d3ac749320b

identifier: http://ema.europa.eu/identifier/EU/1/21/1532/001-004

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - kesimpta

Attesters

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

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.

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 have rash, hives, trouble breathing, swelling of the face, eyelids, lips, mouth, tongue or throat, chest tightness, or feel faint. These could be signs or symptoms of an allergic reaction.
• 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 .

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 + www.kesimpta.eu

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.

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

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

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

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.

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. If necessary, Kesimpta can be left 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 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 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.

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 90429 Nuremberg Germany

Novartis Farmac utica, S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma Vertriebs GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

Other sources of information

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