Human medicines European public assessment report (EPAR): Vyxeos liposomal (previously Vyxeos), daunorubicin,cytarabine, Date of authorisation: 23/08/2018, Revision: 11, Status: Authorised

Overview

Vyxeos liposomal is a cancer medicine used to treat adults with newly diagnosed acute myeloid leukaemia, a cancer of white blood cells. It is used when the leukaemia was caused by previous treatments (e.g. for other cancers) or is associated with certain changes in the bone marrow known as myelodysplasia. The active substances in Vyxeos liposomal are daunorubicin and cytarabine. Expand section Collapse section How is Vyxeos liposomal used? Vyxeos liposomal is given by infusion (drip) into a vein over 90 minutes and the dose is calculated using the patient's height and weight. It is given on days 1, 3 and 5 of the first treatment course. If the medicine works well enough and the doctor considers further courses would be of benefit, Vyxeos liposomal is given on days 1 and 3 of each further course. The doctor may delay doses or stop treatment if the patient has severe side effects. Vyxeos liposomal can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in using cancer medicines. For more information about using Vyxeos liposomal, see the package leaflet or contact your doctor or pharmacist. How does Vyxeos liposomal work? The active substances in Vyxeos liposomal, daunorubicin and cytarabine, have been used together to treat leukaemia and other types of cancer for many years. They interfere in different ways with the production of new DNA within cells, which means the cells are unable to grow and multiply, and they eventually die. In this medicine, daunorubicin and cytarabine are contained in tiny fat droplets called 'liposomes'. The liposomes are expected to remain in the patient's body for longer than conventional daunorubicin and cytarabine medicines and to build up in the patient's bone marrow. The liposomes protect the cancer medicines from being broken down early, which is expected to enhance their effect on cancer cells. What benefits of Vyxeos liposomal have been shown in studies? Vyxeos liposomal has been shown to improve how long patients lived in one main study involving 309 patients with high-risk acute myeloid leukaemia linked to previous treatment or associated with myelodysplasia. The study compared Vyxeos liposomal with conventional daunorubicin and cytarabine infusions. Patients given Vyxeos liposomal lived on average around 9.6 months after treatment, whereas those given conventional daunorubicin and cytarabine lived about 6 months. Some 34% of patients given Vyxeos liposomal (52 of 153) were able to go on to have a stem cell transplant (a potentially curative procedure where the patient's bone marrow is replaced by stem cells to form new, healthy bone marrow) compared with 25% (39 of 156) given conventional treatment. What are the risks associated with Vyxeos liposomal? The most common side effects with Vyxeos liposomal (which may affect more than 1 in 5 people) are hypersensitivity (allergic reactions, especially rash), febrile neutropenia (low white cell counts with fever), oedema (swelling), diarrhoea, colitis (inflamed bowel), mucositis (inflammation of the moist body surfaces), tiredness, muscle and bone pain, belly pain, decreased appetite, cough, headache, chills, arrhythmias (irregular heart rhythm), fever, sleep disorders and hypotension (low blood pressure). For the full list of side effects and restrictions with Vyxeos liposomal, see the package leaflet. Why is Vyxeos liposomal authorised in the EU? Vyxeos liposomal improved survival compared with conventional daunorubicin and cytarabine in patients with acute myeloid leukaemia who have a poor prognosis and few alternatives. The side effects were similar to the known side effects of the active substances and were considered manageable. The European Medicines Agency decided that Vyxeos liposomal's benefits are greater than its risks and it can be authorised for use in the EU. What measures are being taken to ensure the safe and effective use of Vyxeos liposomal? Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vyxeos liposomal have been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Vyxeos liposomal are continuously monitored. Side effects reported with Vyxeos liposomal are carefully evaluated and any necessary action taken to protect patients. Other information about Vyxeos liposomal Vyxeos liposomal received a marketing authorisation valid throughout the EU on 23 August 2018. Vyxeos liposomal : EPAR - Medicine overview Reference Number: EMA/631389/2019 English (EN) (118.26 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View Other languages (22) български (BG) (143.35 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View español (ES) (119.32 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View čeština (CS) (142.56 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View dansk (DA) (119.14 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View Deutsch (DE) (122.94 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View eesti (ET) (106.73 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View ελληνικά (EL) (142.45 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View français (FR) (122.06 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View hrvatski (HR) (141.05 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View italiano (IT) (118.62 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View latviešu (LV) (138.5 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View lietuvių (LT) (143.24 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View magyar (HU) (142.77 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View Malti (MT) (142.34 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View Nederlands (NL) (119.82 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View polski (PL) (142.83 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View português (PT) (120.14 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View română (RO) (140.48 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View slovenčina (SK) (142.05 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View slovenščina (SL) (140.89 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View suomi (FI) (142.43 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View svenska (SV) (117.06 KB - PDF) First published: 26/10/2018 Last updated: 06/03/2020 View Vyxeos : EPAR - Risk-management-plan summary English (EN) (76 KB - PDF) First published: 26/10/2018 View

Product information

Vyxeos liposomal : EPAR - Product Information English (EN) (402.73 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View Other languages (24) български (BG) (553.61 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View español (ES) (421.42 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View čeština (CS) (486.7 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View dansk (DA) (447.43 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View Deutsch (DE) (448 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View eesti (ET) (456.69 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View ελληνικά (EL) (493.27 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View français (FR) (443.31 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View hrvatski (HR) (445.63 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View italiano (IT) (432.03 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View latviešu (LV) (614 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View lietuvių (LT) (466.7 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View magyar (HU) (474.28 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View Malti (MT) (506.68 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View Nederlands (NL) (684.95 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View polski (PL) (471.39 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View português (PT) (443.94 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View română (RO) (461.54 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View slovenčina (SK) (475.79 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View slovenščina (SL) (439.84 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View suomi (FI) (433.43 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View svenska (SV) (445.72 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View Íslenska (IS) (440.7 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View norsk (NO) (434.94 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View Latest procedure affecting product information: VR/0000335559 29/07/2026 This medicine's product information is available in all official EU languages . Select 'available languages' to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Vyxeos liposomal : EPAR - All Authorised presentations English (EN) (58.83 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View Other languages (24) български (BG) (50.85 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View español (ES) (55.15 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View čeština (CS) (47.43 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View dansk (DA) (45.99 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View Deutsch (DE) (58 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View eesti (ET) (53.93 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View ελληνικά (EL) (59.68 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View français (FR) (55.72 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View hrvatski (HR) (84.1 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View italiano (IT) (55.06 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View latviešu (LV) (58.94 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View lietuvių (LT) (57.95 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View magyar (HU) (58.7 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View Malti (MT) (59.63 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View Nederlands (NL) (55.05 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View polski (PL) (59.93 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View português (PT) (56.7 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View română (RO) (57.7 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View slovenčina (SK) (61.31 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View slovenščina (SL) (56.96 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View suomi (FI) (55.38 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View svenska (SV) (55.08 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View Íslenska (IS) (57.85 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View norsk (NO) (57.45 KB - PDF) First published: 26/10/2018 Last updated: 04/08/2026 View

Product details

Name of medicine Vyxeos liposomal (previously Vyxeos) Active substance daunorubicin hydrochloride cytarabine International non-proprietary name (INN) or common name daunorubicin cytarabine Therapeutic area (MeSH) Leukemia, Myeloid, Acute Anatomical therapeutic chemical (ATC) code L01XY01 Pharmacotherapeutic group Antineoplastic agents Therapeutic indication Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Authorisation details

EMA product number EMEA/H/C/004282 Orphan This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation . Marketing authorisation holder Jazz Pharmaceuticals Ireland Limited Fifth Floor Waterloo Exchange Waterloo Road D04 E5W7 Dublin 4 Ireland Opinion adopted 26/04/2018 Marketing authorisation issued 23/08/2018 Revision 11

Assessment history

Expand section Collapse section Changes since initial authorisation of medicine Vyxeos liposomal : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (147.85 KB - PDF) First published: 04/08/2026 View Vyxeos liposomal : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (181.94 KB - PDF) First published: 08/10/2019 Last updated: 04/08/2026 View Vyxeos liposomal : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan Reference Number: EMADOC-1700519818-3247316 English (EN) (127.54 KB - PDF) First published: 04/08/2026 View Vyxeos liposomal : EPAR - Assessment report - Variation Adopted Reference Number: EMA/665588/2022 English (EN) (3.58 MB - PDF) First published: 27/07/2022 View Initial marketing authorisation documents Vyxeos : EPAR - Public assessment report Adopted Reference Number: EMA/665588/2022 English (EN) (4.74 MB - PDF) First published: 26/10/2018 View Vyxeos : Orphan maintenance assessment report (initial authorisation) Adopted Reference Number: EMA/496701/2018 English (EN) (235.67 KB - PDF) First published: 26/10/2018 View CHMP summary of positive opinion for Vyxeos Adopted Reference Number: EMA/CHMP/239619/2018 English (EN) (69.79 KB - PDF) First published: 29/06/2018 Last updated: 29/06/2018 View

More information on Vyxeos liposomal (previously Vyxeos)

EU/3/11/942 - orphan designation for treatment of acute myeloid leukaemia EMEA-001858-PIP02-16-M04 - paediatric investigation plan

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Medicines