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AstraZeneca

Kesimpta
ofatumumab

Package leaflet: Information for the patient


Kesimpta 20 mg solution for injection in pre-filled syringe

ofatumumab


imageThis medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

- if you have been told that you have severe problems with your immune system.


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:


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’.


  1. How to use Kesimpta


    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.


  2. 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 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

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      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.

  3. 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 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.


  4. Contents of the pack and other information What Kesimpta contains


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 25

90429 Nuremberg Germany


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Novartis Farmacéutica SA Ronda de Santa Maria 158

08210 Barbera del Vallès, Barcelona Spain

For any information about this medicine, please 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 Vertriebs 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

United Kingdom (Northern Ireland)

Novartis Ireland Limited Tel: +44 1276 698370


This leaflet was last revised in

.

Instructions for use of Kesimpta pre-filled syringe


It is important that you understand and follow these instructions for use before injecting Kesimpta. Talk to your doctor, pharmacist or nurse if you have any questions before you use Kesimpta for the first time.


Remember:


Picture D

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Picture E (caregiver and healthcare

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professional only)


Step 8. Using a circular motion, clean the injection site with the alcohol wipe. Leave it to dry before injecting. Do not touch the cleaned area again before injecting.

Giving your injection


Step 9. Carefully remove the needle cap from the

pre-filled syringe (see Picture F). Throw away the needle cap. You may see a drop of liquid at the end of the needle. This is normal.


Step 10. With one hand, gently pinch the skin at the injection site. With your other hand insert the needle into your skin as shown (see Picture G). Push the needle all the way in to make sure that you inject your full dose.


Step 11. Hold the pre-filled syringe finger grips as shown (see Picture H). Slowly press down on the plunger as far as it will go, so that the plunger head is completely between the syringe guard wings.


Step 12. Continue to press fully on the plunger for 5 seconds while holding the syringe in place.


Step 13. Slowly release the plunger until the needle is covered (see Picture I), and then remove the syringe from the injection site.


Step 14. There may be a little 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.

Picture F

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Picture G

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Picture H

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Picture I

How should I dispose of the used Kesimpta pre-filled syringe?



Step 15. Dispose of your used pre-filled syringe in a sharps disposal container (i.e. a puncture-resistant closable container, or similar) (see Picture J).


Keep the sharps container out of the reach of children.

image

Picture J