Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
Enfortumab vedotin
Astellas Pharma Europe B.V.
L01FX13
enfortumab vedotin
Antineoplastic agents
Carcinoma, Transitional Cell; Urologic Neoplasms
Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.
Revision: 1
Authorised
2022-04-13
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PADCEV 20 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION PADCEV 30 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION enfortumab vedotin This 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 ARE GIVEN 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. − If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Padcev is and what it is used for 2. What you need to know before you are given Padcev 3. How to use Padcev 4. Possible side effects 5. How to store Padcev 6. Contents of the pack and other information 1. WHAT PADCEV IS AND WHAT IT IS USED FOR Padcev contains the active substance enfortumab vedotin which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells. The monoclonal antibody recognises certain cancer cells and delivers the substance to the cancer cells. This medicine is used in adults to treat a kind of cancer called bladder cancer (urothelial carcinoma). People get Padcev when their cancer has spread or cannot be taken out by surgery. Padcev is given to people that have received an immunotherapy medicine and also received a chemotherapy-containing platinum medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PADCEV YOU MUST NOT BE GIVEN PADCEV − if you are allergic to enfortumab vedotin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor immediately if you: − have any of the following skin reaction symptoms: • rash or itching that continues to get worse or comes back after t Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Padcev 20 mg powder for concentrate for solution for infusion Padcev 30 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Padcev 20 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 20 mg enfortumab vedotin. Padcev 30 mg powder for concentr ate for solution for infusion One vial of powder for concentrate for solution for infusion contains 30 mg enfortumab vedotin. After reconstitution, each mL of solution contains 10 mg of enfortumab vedotin. Enfortumab vedotin is comprised of a fully human IgG1 kappa antibody, conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable maleimidocaproyl valine-citrulline linker. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white lyophilized powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Padcev should be initiated and supervised by a physician experienced in the use of anti-cancer therapies. Ensure good venous access prior to starting treatment (see section 4.4). Posology The recommended dose of enfortumab vedotin is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28 Izlasiet visu dokumentu