Country: European Union
Language: English
Source: EMA (European Medicines Agency)
clofarabine
Sanofi B.V.
L01BB06
clofarabine
Antineoplastic agents
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis.
Revision: 33
Authorised
2006-05-29
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE USER EVOLTRA 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION clofarabine 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 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. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • 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 Evoltra is and what it is used for 2. What you need to know before you use Evoltra 3. How to use Evoltra 4. Possible side effects 5. How to store Evoltra 6. Contents of the pack and other information 1. WHAT EVOLTRA IS AND WHAT IT IS USED FOR Evoltra contains the active substance clofarabine. Clofarabine is one of a family of medicines called anticancer medicines. It works by hindering the growth of abnormal white blood cells, and eventually kills them. It works best against cells which are multiplying quickly – such as cancer cells. Evoltra is used to treat children (≥ 1 year old), teenagers and young adults up to 21 years old with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working. Acute lymphoblastic leukaemia is caused by abnormal growth of some types of white blood cells. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EVOLTRA DO NOT USE EVOLTRA - IF YOU ARE ALLERGIC to clofarabine or any of the other ingredients of this medicine (listed in section 6); - IF YOU ARE BREAST-FEEDING (please read the section “Pregnancy and breast-feeding” below); - IF YOU HAVE SEVE Read the complete document
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 Evoltra 1 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine. Excipient with known effect Each 20 ml vial contains 180 mg of sodium chloride, which is equivalent to 3.6 mg of sodium per ml (0.2 mmol). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy must be initiated and supervised by a physician experienced in the management of patients with acute leukaemias. Posology _ _ _Adult population (_ _including elderly) _ There are currently insufficient data to establish the safety and efficacy of clofarabine in adult patients (see section 5.2). _Paediatric population _ _ _ _Children and adolescents (≥ 1 year old) _ The recommended dose in monotherapy is 52 mg/m 2 of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days. Body surface area must be calculated using the actual height and weight of the patient before the start of each cycle. Treatment cycles should be repeated every 2 to 6 weeks Read the complete document