HIS FAMILY . TOGETHER , LONGER .
Superior overall survival vs conventional chemotherapy in patients with high-risk * AML 1
OS maintained above 50 % at 5 years post-randomisation in a post-hoc analysis of Vyxeos Liposomal patients who underwent transplant ‡ 2
Comparable safety profile between Vyxeos Liposomal and conventional chemotherapy 1
5 years
LAYING THE
FOUNDATI N
TOWARDS LONG-TERM SURVIVAL IN HIGH-RISK * AML 4
Monitor hepatic function more frequently if co-administered with hepatotoxic agents . Pregnancy , lactation and fertility : There are no data on use in pregnant women . Do not use during pregnancy unless the benefit of treatment outweighs the risk . It is not known if Vyxeos liposomal is excreted in human milk therefore advise mothers to discontinue breastfeeding during therapy . Advise patients 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 . Hypersensitivity , febrile neutropenia , oedema , diarrhoea / colitis , mucositis , fatigue , musculoskeletal pain , abdominal pain , decreased appetite , cough , headache , chills , arrhythmia , pyrexia , sleep disorders , and hypotension are the most frequently occurring adverse reactions ( ADRs ). Infection , cardiotoxicity and haemorrhage are the most serious and frequently occurring ADRs . Storage and Handling : Store in a refrigerator ( 2 ° C - 8 ° C ). Vyxeos liposomal is cytotoxic ; unused product or waste material should be disposed of in accordance with local requirements for cytotoxic agents . Legal category : Prescription only medicine ( POM ). Marketing authorisation number : EU / 1 / 18 / 1308 / 001 Package quantity and Cost : carton containing 1 × 50 mL vial . Refer to local prescribing information for price . Further information is available from Marketing Authorisation Holder : Jazz Pharmaceuticals Ireland Ltd ., 5th Floor , Waterloo Exchange , Waterloo Road , Dublin D04 E5W7 , Ireland . Date of revision : July 2022 . INT- VYX-1900009 . Vyxeos ® is a registered trademark of Celator Pharmaceuticals , Inc . ( a Jazz Pharmaceuticals subsidiary ) 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 adverse events via their national reporting system ( see Section 4.8 of SmPC ). Adverse events should also be reported to Jazz Pharmaceuticals by email to medinfo-int @ jazzpharma . com or phone via + 353 1 968 1631 ( may include an international call charge ).
* High-risk AML defined as newly diagnosed , t-AML or AML-MRC † Superior OS vs conventional chemotherapy in patients with high-risk * AML
1
‡ Estimated from Kaplan Meier curve
References 1 . Lancet JE et al . J Clin Oncol 2018 ; 36 ( 26 ): 2684-92 . 2 . Uy GL et al . Blood Adv 2022 ; 6 ( 17 ): 4989-93 . 3 . Vyxeos Liposomal . European Summary of Product Characteristics . 4 . Lancet JE et al . Lancet Haematol 2021 ; 8 ( 7 ): e481-91 .
Abbreviations AML : acute myeloid leukaemia . AML-MRC : AML with myelodysplasia-related changes . Conventional chemotherapy : cytarabine & daunorubicin ( 7 + 3 in induction and 5 + 2 in consolidation , where given ). OS : overall survival . t-AML : therapy-related AML .
Date of preparation : August 2022 Job code : INT-VYX-2200168