Kesimpta Solution Prefilled Pen 20 Mg 0.4 Ml (Refrigerator)

Product Description:

• Kesimpta contains the active substance ofatumumab. 
• Ofatumumab belongs to a group of medicines called monoclonal antibodies.
• Kesimpta is used to treat adults with relapsing forms of multiple sclerosis (RMS).

How Kesimpta works:

• Kesimpta acts targeted by binding to CD20 on the surface of B cells. 
• B cells are a type of white blood cell that is part of the immune system (the body's defense system). 
• In multiple sclerosis , the immune system attacks the protective layer around the nerve cells. B cells are involved in this process. 
• Kesimpta acts specifically on B cells and removes them, thereby reducing the likelihood of a relapse, relieving symptoms and delaying the progression of the disease.

How To Use:

• Always use this medicine exactly as your doctor has told you. 
• Contact a doctor or pharmacist if you are unsure.
• Kesimpta is given by subcutaneous injection (injection under the skin).
• The first injection must be carried out under the guidance of a healthcare professional.
• Kesimpta pre-filled pens are for single use only.
• You can use Kesimpta at any time of the day (morning, afternoon or evening).

How much Kesimpta you should use and how often you should use it:

• Do not exceed the dose prescribed by your doctor.

The starting dose is :

• 20 mg Kesimpta given on the first day of treatment (week 0) and after 1 and 2 weeks (weeks 1 and 2). After the first 3 injections, there is no injection in the following week (week 3).
• From week 4 onwards, you must have one injection every month, and the recommended dose is 20 mg Kesimpta.

If you take too much Kesimpta:

• If you have injected too much Kesimpta, you must contact your doctor immediately.

If you have forgotten to take Kesimpta:

• To get the full benefit of Kesimpta, it is important that you receive each injection on time.
• If you have forgotten an injection with Kesimpta, you must give the injection 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 set this dose and should not be based on the original schedule.

If you stop treatment with Kesimpta:

• Do not stop treatment with Kesimpta or change the dose without talking to your doctor.
• Some side effects may be related to low levels of B cells in your blood.
• After you have finished treatment with Kesimpta, the number of B cells will gradually increase to a normal level.
• It may take several months.
• During that period, you may still experience some of the side effects described in this leaflet.
• Ask your doctor or pharmacist if you have any questions about the use of this medicine.

Warnings and precautions:

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 serious problems with your immune system.
• If you have a serious infection .
• If you have cancer .

Talk to your doctor before using Kesimpta:

• Kesimpta can cause the hepatitis B virus to become active again. 
• Your doctor will take a blood test to check if you are at risk of hepatitis B infection
• . If it shows that you have had hepatitis B or are a carrier of the hepatitis B virus, the doctor will refer you to a specialist.
• Before you start treatment with Kesimpta, your doctor may want to check your immune system.
• If you have an infection , the doctor may decide that you cannot receive Kesimpta, or may want to postpone treatment with Kesimpta until the infection has passed.
• Your doctor will check whether you need any vaccines before starting treatment with Kesimpta.
  If you need a type of vaccine called live or live, weakened vaccine, you should get it at least 4 weeks before you start treatment with Kesimpta. Other types of vaccines should be given at least 2 weeks before you start treatment with Kesimpta.

Pregnancy and feeding:

• Talk to your doctor before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant.

Pregnancy:

• You must avoid becoming pregnant while using Kesimpta and for 6 months after you stop using it.

Breastfeeding:

• Kesimpta can be excreted in breast milk.
• Talk to your doctor about the benefits and risks before you breastfeed your baby while using Kesimpta.

Vaccination of newborn babies:

• Talk to your doctor or pharmacist before vaccinating your newborn baby if you have used Kesimpta during pregnancy .

Driving and using machines:

• Kesimpta is unlikely to affect your ability to drive or use machines.

Ingredients:

• The active substance is ofatumumab. Each pre-filled pen contains 20 mg ofatumumab.
• 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 the contents of the pack:

• Kesimpta solution for injection is clear to slightly cloudy and colorless to slightly yellowish brown.