Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Mogamulizumab
Kyowa Kirin Holdings B.V.
L01XC25
mogamulizumab
Antineoplastic agents
Sezary Syndrome; Mycosis Fungoides
Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
Revision: 6
Authorised
2018-11-22
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT POTELIGEO 4 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION mogamulizumab . READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What POTELIGEO is and what it is used for 2. What you need to know before you use POTELIGEO 3. How POTELIGEO is given 4. Possible side effects 5. How to store POTELIGEO 6. Contents of the pack and other information 1. WHAT POTELIGEO IS AND WHAT IT IS USED FOR POTELIGEO contains the active substance mogamulizumab, which belongs to a group of medicines called monoclonal antibodies. Mogamulizumab targets cancer cells which are then destroyed by the immune system (the body’s defence). This medicine is used to treat adults with mycosis fungoides and Sézary syndrome, which are types of cancers called cutaneous T-cell lymphomas. The medicine is for use in patients who have received at least one medicine given by mouth or by injection. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE POTELIGEO _ _ DO NOT USE POTELIGEO: - if you are allergic to mogamulizumab or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR NURSE BEFORE USING POTELIGEO IF YOU: - ever had a severe skin reaction with this medicine. - ever had an infusion reaction with this medicine (possible symptoms of an infusion reaction are listed in section 4). - have human immunodeficiency virus (HIV), herpes, cytomegalovirus (CMV), or hepatitis B or C infection, or other on-going infections. - have had or plan to have a stem cell transplant, either using your own cells or a donor’s. - have had tumour lysis syndrome (a complication involving the destruction of ca Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT POTELIGEO 4 mg/mL concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 20 mg of mogamulizumab in 5 mL, corresponding to 4 mg/mL. Mogamulizumab is produced in Chinese hamster ovary cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear to slightly opalescent, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS POTELIGEO is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated and supervised by physicians experienced in the treatment of cancer, and should only be administered by healthcare professionals in an environment where resuscitation equipment is available. Posology The recommended dose is 1 mg/kg mogamulizumab administered as an intravenous infusion over at least 60 minutes. Administration is weekly on days 1, 8, 15 and 22 of the first 28-day cycle, followed by infusions every two weeks on Days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity. POTELIGEO should be administered within 2 days of the scheduled day. If a dose is missed by more than 2 days, the next dose should be administered as soon as possible, after which the dosing schedule should be resumed with doses given based on the new scheduled days. Pre-medication with anti-pyretic and anti-histamine is recommended for the first POTELIGEO infusion. If an infusion reaction occurs, administer pre-medication for subsequent POTELIGEO infusions. Dose modification _Dermatologic reactions_ Patients receiving mogamulizumab have experienced drug rash (drug eruption), some of which were severe and/or serious. _ _ • In the event of a rash (drug related) with severity of Grade 2 or 3 (moderate or severe), t Lestu allt skjalið