TOGETHER . LONGER
.†
Superior overall survival vs conventional chemotherapy in patients with high-risk * AML 2
AM
5-YEAR DATA
OS benefit sustained over five years : 18 % with Vyxeos Liposomal vs 8 % with conventional chemotherapy , HR : 0.70 , 95 % CI : 0.55-0.91 ‡ 3
OS maintained above 50 % at five years in a post-hoc analysis of Vyxeos Liposomal patients who underwent transplant ‡ 3
Comparable frequency and severity of adverse events between Vyxeos Liposomal and conventional chemotherapy 2
For more meaningful time together
LAYING THE FOUNDATI N TOWARDS LONG-TERM SURVIVAL IN HIGH-RISK * AML
be avoided . Killed or inactivated vaccines may be administered ; however , the response to such vaccines may be diminished . The absorption of oral accompanying medicinal products may be considerably influenced by gastrointestinal mucositis and / or diarrhoea frequently occurring in association with intensive chemotherapy . Pregnancy , lactation and fertility : There are no data on use in pregnant women . It should not be used during pregnancy unless the benefit of treatment outweighs the risk . It is not known if Vyxeos Liposomal is excreted in human milk therefore mothers should be advised to discontinue breastfeeding during therapy . Patients should be advised to avoid becoming pregnant while receiving Vyxeos Liposomal . Male patients and women of childbearing potential must use an effective method of contraception during treatment and for 6 months following the last dose . Male fertility may be compromised by treatment . Undesirable effects : Please refer to the full SmPC for the complete list of undesirable effects . The most frequently occurring adverse reactions were hypersensitivity , febrile neutropenia , oedema , diarrhoea / colitis , mucositis , fatigue , musculoskeletal pain , abdominal pain , decreased appetite , cough , headache , chills , arrhythmia , pyrexia , sleep disorders , and hypotension . The most serious and frequently occurring ADRs were infection , cardiotoxicity and haemorrhage . Overdose : There is no specific antidote for overdose and treatment should be symptomatic . Storage and Handling : Store in a refrigerator ( 2 ° C - 8 ° C ). Shelf life of unopened vials : 2 years . Keep vial in the original carton to protect from light and store in an upright position . Vyxeos Liposomal is a cytotoxic medicinal product intended for single use only . Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic agents . Legal category : POM . Marketing authorisation number : EU / 1 / 18 / 1308 / 001 . Package quantity and Cost : carton containing 1 × 50 mL vial . Price differs across countries . Further information is available from the Marketing Authorisation Holder : Jazz Pharmaceuticals Ireland Ltd ., 5th Floor , Waterloo Exchange , Waterloo Road , Dublin D04 E5W7 , Ireland .
Date of preparation : November 2019 . Job Code : INT-VYX-1900009 Vyxeos ® is a registered trade mark . For country specific information please refer to your local SmPC or Product Monograph
Adverse events should be reported . Healthcare professionals are asked to report any suspected adverse events via their national reporting system . In the United Kingdom reporting forms and information can be found at : https :// yellowcard . mhra . gov . uk / Adverse events should also be reported to Jazz Pharmaceuticals by email to aereporting @ jazzpharma . com or by fax to + 44 ( 0 ) 1865 598765
References : 1 . U . S . Food and drug administration 2017 . FDA news release : FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia . 2 . Lancet JE et al . J Clin Oncol 2018 ; 36 ( 26 ): 2684-92 . 3 . Lancet JE et al . Presented at the Congress of the European Hematological Association
( EHA ) 2020 , EP556 .
Abbreviations : AML : acute myeloid leukaemia . AML-MRC : AML with myelodysplasia-related changes . CI : confidence interval . Conventional chemotherapy : 7 + 3 in induction and 5 + 2 in second induction and consolidation when given . HR : hazard ratio . OS : overall survival . t-AML : therapy-related AML .
Date of preparation : June 2021 Job code : INT-VYX-2100082