Kesimpta 20 mg solucion inyectable en pluma precargada

Product Information for the Patient

Kesimpta 20 mg Pre-filled Injectable Pen

ofatumumab

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

What is Kesimpta

Kesimpta contains the active ingredient ofatumumab. Ofatumumab belongs to a group of medicines known as monoclonal antibodies.

What is Kesimpta used for

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

How Kesimpta works

Kesimpta works by binding to a target known as CD20 on the surface of B lymphocytes. B lymphocytes are a type of white blood cell that is part of the immune system (the body's defenses). In multiple sclerosis, the immune system attacks the protective covering around nerve cells. B lymphocytes are involved in this process. Kesimpta targets B lymphocytes and eliminates them. In this way, it reduces the likelihood of a relapse, alleviates symptoms, and slows 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 diagnosed with severe problems in your immune system.
• if you have a serious infection.
• if you have cancer.

Warnings and precautions

Consult your doctor before starting to use Kesimpta

• Kesimpta may cause the hepatitis B virus to reactivate. Your doctor will perform a blood test to check if you are at risk of hepatitis B infection. If the test result 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 starting treatment with Kesimpta, your doctor may check your immune system.
• If you have an infection, your doctor may decide that you cannot use Kesimpta or that you must delay treatment with Kesimpta until the infection has resolved.
• Your doctor will check if you need any vaccinations before starting treatment with Kesimpta. If you need a type of vaccine known as a live or live attenuated vaccine, it should be administered at least 4 weeks before starting treatment with Kesimpta. Other types of vaccines should be administered at least 2 weeks before starting treatment with Kesimpta.

While using Kesimpta

Inform your doctor:

• if you experience 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 injecting Kesimpta, especially after the first injection. The first injection should be performed under the guidance of a healthcare professional.
• if you have an infection. You may be more susceptible to infections or if you already have an infection, it may worsen. This is because the immune cells that Kesimpta acts on also help fight infections. Infections may be severe and sometimes even life-threatening.
• if you are planning to be vaccinated. Your doctor will inform you if the vaccine you need is a live, live attenuated, or other type of vaccine. During treatment with Kesimpta, you should not receive live or live attenuated vaccines as you may develop an infection. Other types of vaccines may not work as well if received during treatment with Kesimpta.

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

• if you experience hives, difficulty breathing, facial swelling, eyelid swelling, lip swelling, mouth swelling, tongue swelling, or throat swelling, or if you feel weak. These may be signs or symptoms of an allergic reaction.
• if you think your multiple sclerosis is worsening (e.g., you experience weakness or changes in vision) or if you notice any new or unusual symptoms. These effects may be indicative of a rare brain disorder known as progressive multifocal leukoencephalopathy (PML), which is caused by viral infection.

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 taken recently, or may need to take any other medicine.

Especially, inform your doctor or pharmacist:

• if you are taking, have taken recently, or may need to take medicines that affect the immune system. This is because the effects on the immune system may be additive.
• if you are planning to be vaccinated (see above “Warnings and Precautions”).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medicine.

Pregnancy

You should avoid becoming pregnant while using Kesimpta and for 6 months after stopping treatment.

If you are a fertile woman, you should use an effective contraceptive method during treatment and for 6 months after stopping treatment with Kesimpta. Consult your doctor about the available options.

If you become pregnant or think you may be pregnant during treatment or within 6 months after the last dose, inform your doctor immediately. Your doctor will inform you of the potential risks of Kesimpta during pregnancy. This is because Kesimpta can reduce the number of immune system cells (B lymphocytes) in both the mother and the fetus. Your doctor should report your pregnancy to Novartis. You can also report your pregnancy by contacting your local Novartis representative (see section 6), as well as contacting your doctor.

Breastfeeding

Kesimpta may pass into breast milk. Consult your doctor about the benefits and risks before breastfeeding while using Kesimpta.

Vaccination of newborn babies

Consult your doctor or pharmacist before vaccinating your newborn baby if you used Kesimpta during pregnancy (see above “Warnings and Precautions”).

Driving and operating machines

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

Kesimpta contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Kesimpta is administered via subcutaneous injection (injection under the skin).

The first injection should be performed under the guidance of a healthcare professional.

The Kesimpta pre-filled pens are for single use only.

You can consult the detailed instructions on how to inject Kesimpta in the "Kesimpta in Pluma Sensoready Use Instructions" section at the end of this leaflet.

‘QR code to include’ +www.kesimpta.eu

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

How much Kesimpta and how often to administer

Do not exceed the dose prescribed by your doctor.

• The initial dosing is 20 mg of Kesimpta administered on the first day of treatment (Week 0) and 1 week and 2 weeks later (Week 1 and Week 2). After these first 3 injections, the following week no injection should be administered (Week 3).
• The recommended dose is 20 mg of Kesimpta once a month, starting from Week 4.

For how long to use Kesimpta

Continue using Kesimpta every month for the duration indicated by your doctor.

Your doctor will periodically monitor your disease status to check if the treatment is having the desired effect.

If you have any doubts about how long you should use Kesimpta, ask your doctor, pharmacist, or nurse.

If you use more Kesimpta than you should

If too much Kesimpta has been administered, inform your doctor immediately.

If you forgot to use Kesimpta

To get the full benefit of Kesimpta, it is essential to administer each injection on time.

If you have forgotten to administer a Kesimpta injection, administer it as soon as possible. Do not wait until the next scheduled dose. The administration times of the following injections should then be calculated from the day the dose was administered and not based on the original calendar (see also the previous section "How much Kesimpta and how often to administer").

If you interrupt treatment with Kesimpta

Do not interrupt treatment with Kesimpta or change your dose without first discussing it with your doctor.

Some side effects may be related to low levels of B lymphocytes in the blood. After interrupting treatment with Kesimpta, your B lymphocyte levels in the blood will gradually increase to normal levels. This may take several months, during which you may still experience some of the side effects described in this leaflet.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following are the adverse effects of Kesimpta. If any of these adverse effects affect you severely, inform your doctor, pharmacist, or nurse.

Very Frequent(may affect more than 1 in 10 patients)

• Upper respiratory tract infections, with symptoms such as throat irritation and nasal discharge
• Injection-related reactions, such as fever, headache, muscle pain, chills, and fatigue - these usually appear within 24 hours after a Kesimpta injection and mainly after the first injection
• Urinary tract infections
• Reactions at the injection site, such as redness, pain, itching, and swelling at the injection site

Frequent(may affect up to 1 in 10 patients)

• Decrease in the blood level of a protein known as immunoglobulin M, which helps protect against infections
• Oral herpes
• Nausea, vomiting (reported in association with injection-related reactions)

Unknown Frequency(cannot be estimated from available data)

• Allergic reactions, with symptoms such ashives, urticaria, difficulty breathing, facial swelling, eyelid swelling, lip swelling, mouth swelling, tongue swelling, or throat swelling, chest tightness, or feeling weak

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD and on the label after EXP. The expiration date is the last day of the month indicated.

Store the pre-filled pen(s) in the outer packaging to protect it from light. Store in the refrigerator (between 2°C and 8°C). Do not freeze.

In case of need, 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 be returned to the refrigerator for a maximum of 7 days.

Do not use this medication if you observe that the solution contains visible particles or is cloudy.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Kesimpta

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

Appearance of the product and contents of the pack

Kesimpta injectable solution is a transparent to slightly opalescent solution, and colorless to yellowish-brown.

Kesimpta is available in single-dose packs containing 1 pre-filled pen and in multiple packs consisting of 3 boxes, with 1 pre-filled pen in each.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Novartis Ireland Limited

Vista Building

Elm Park, Merrion Road

Ballsbridge

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.

Instructions for use of Kesimpta in Sensoready pen

It is essential that you understand and follow these instructions for use before injecting Kesimpta. If you have any doubts, consult your doctor, pharmacist, or nurse before using Kesimpta for the first time.

Remember:

• Do not usethe pen if the packaging or pen seal is broken. Keep the pen in the sealed packaging until you are ready to use it.
• Do not shakethe pen.
• If the pen falls, do not use it if it appears to be damaged, or if the pen fell without the cap being in place.
• Dispose of the used pen immediately after use.Do not re-use a pen.

How should I store Kesimpta?

• Store the pen in the refrigerator between 2°C and 8°C.
• Store the pen in the original packaging to protect it from light until you are ready to use it.
• Do not freezethe pen.

Keep Kesimpta out of the sight and reach of children.

Parts of the Sensoready pen of Kesimpta (see Image A):

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

What you need for the injection:

Included in the pack:

See the section “How to dispose of the used Sensoready pen of Kesimpta?” at the end of these Instructions for Use.

Before the injection:

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

How to dispose of the used Sensoready pen of Kesimpta?