Kesimpta 20 Mg / 0.4 Ml Injection 1 Prefilled Pen

1. What this product is and what it is used for 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 indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 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 and which play a role in multiple sclerosis. Kesimpta targets and removes the B cells and thereby reduces the chance of having a relapse, relieves symptoms and slows down the progression of the disease. 2. What you need to know before you use this product 2. Before treatment with KESIMPTA Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet a. Do not take KESIMPTA If you if you are allergic to ofatumumab or any of the other ingredients of this medicine (see section 6). b. Take special care with KESIMPTA Infections - Contact your doctor for any signs of infection during treatment or after the last dose. Signs include fever, chills, constant cough, or dysuria. - Your doctor will check if KESIMPTA may cause reactivation of hepatitis B infection and that monitoring will be required if you are at risk. - Please be advised that PML has happened with an intravenous form of ofatumumab administered at a higher intravenous dosage in patients with CLL, as well as with drugs that are similar to KESIMPTA, and may happen with KESIMPTA. - Please be informed that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. It’s important Contact your doctor if you develop any symptoms suggestive of PML. - Please be informed that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes - Vaccinations Please be advised to complete any required live or live-attenuated vaccinations at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of KESIMPTA for inactivated vaccines. Administration of live-attenuated or live vaccines is not recommended during KESIMPTA treatment and until B-cell recovery. Injection-Related Reactions Please be informed about the signs and symptoms of injection-related reactions, and that these reactions generally occur within 24 hours and predominantly following the first injection. Please be advised to contact your doctor if you experience signs or symptoms of injection-related reactions. c. Taking other medicines, herbal or dietary supplements 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 suppress or modulate the immune system, including other medicines used to treat MS such as ocrelizumab, cladribine, fingolimod, natalizumab, teriflunomide, mitoxantrone or dimethyl fumarate. This is because these may have an added effect on the immune system. - if you plan to have any vaccinations (see section Take special care with KESIMPTA). d. 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. e.Pregnancy and breast-feeding Pregnancy For females of childbearing potential, please be advised to use effective contraception while receiving KESIMPTA and for 6 months after the last treatment of KESIMPTA. 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 if you have used Kesimpta during your pregnancy f. Driving and using machines Kesimpta is unlikely to affect your ability to drive and use machines. 3. How to use this product. 3. How to use KESIMPTA How much KESIMPTA to take Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How much Kesimpta to use and how often to use it Do not exceed the dose prescribed by your doctor. - The initial dose is 20 mg Kesimpta administered by subcutaneous injection at weeks 0, 1 and 2. There is no injection at week 3. - Starting at week 4 and then every month, the recommended dose is 20 mg Kesimpta administered by subcutaneous injection. 4. 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. Most are mild to moderate and will generally disappear after a few days to a few weeks of treatment. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse. Very common side effects (may affect more than 1 in 10 people) - upper respiratory tract infection, with symptoms such as sore throat and runny nose - injection-site reactions, such as redness, pain, itching and swelling at the injection site - injection-related reactions, such as fever, headache, muscle pain, chills and tiredness - decrease in the blood level of a specific protein called immunoglobulin M, which helps protect against infection 5. How to store this product 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 pen(s) in the outer carton in order to protect from light. Store in a refrigerator (2°C – 8°C). Do not freeze and do not shake. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how