Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
gemtuzumab ozogamicin
Pfizer Europe MA EEIG
L01XC05
gemtuzumab ozogamicin
Antineoplastic agents
Leukemia, Myeloid, Acute
Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).
Revision: 12
Authorised
2018-04-19
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER MYLOTARG 5 mg powder for concentrate for solution for infusion gemtuzumab ozogamicin 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 MYLOTARG is and what it is used for 2. What you need to know before you are given MYLOTARG 3. How MYLOTARG will be given 4. Possible side effects 5. How to store MYLOTARG 6. Contents of the pack and other information 1. What MYLOTARG is and what it is used for MYLOTARG contains the active substance gemtuzumab ozogamicin, an anticancer medicine, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells. This substance is delivered to cancer cells by the monoclonal antibody. A monoclonal antibody is a protein which recognises certain cancer cells. MYLOTARG is used to treat a certain type of blood cancer called acute myeloid leukaemia (AML) in which the bone marrow makes abnormal white blood cells. MYLOTARG is intended for the treatment of AML for patients aged 15 years and above who have not tried other treatments. MYLOTARG is not for use in patients with a type of cancer called acute promyelocytic leukaemia (APL). 2. What you need to know before you are given MYLOTARG MYLOTARG should not be given if you: are allergic to gemtuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions When you first receive this medicine and during the course of treatment, tell your doctor or nurse if you: have or ever had liver problems: MYLOTARG may cause, during or after treatment, a potentially life-threatening condition called hepatic venoocclusive disease, in which the blood Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT MYLOTARG 5 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of powder for concentrate for solution for infusion contains 5 mg gemtuzumab ozogamicin. After reconstitution (see section 6.6), the concentrated solution contains 1 mg/mL gemtuzumab ozogamicin. Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanised immunoglobulin [Ig] G4, kappa antibody produced by mammalian cell culture in NS0 cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). White to off-white cake or powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients aged 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL) (see sections 4.4 and 5.1). 4.2 Posology and method of administration MYLOTARG should be administered under the supervision of a physician experienced in the use of anticancer medicinal products and in an environment where full resuscitation facilities are immediately available. MYLOTARG should be used only in patients eligible to receive intensive induction chemotherapy. Premedication with a corticosteroid, antihistamine, and acetaminophen (or paracetamol) is recommended 1 hour prior to dosing to help ameliorate infusion-related symptoms (see section 4.4). Appropriate measures to help prevent the development of tumour lysis-related hyperuricaemia, such as hydration, administration of antihyperuricemic or other agents for treatment of hyperuricaemia should be taken (see section 4.4). 3 Posology Induction The recommended dose of MYLOTAR Leggi il documento completo