See the data at www . vyxeos . eu
Vyxeos Liposomal is indicated for the treatment of adults with newly diagnosed , t-AML and AML-MRC 3
EU Prescribing Information Vyxeos ® Liposomal 44mg / 100mg powder for concentrate for solution for infusion ( Daunorubicin and cytarabine ) Please refer to local Summary of Product Characteristics ( SmPC ) before prescribing . Presentation : Purple lyophilised cake of powder for concentrate for solution for infusion . Each vial contains 44 mg daunorubicin and 100 mg cytarabine . After reconstitution the solution contains 2.2 mg / mL daunorubicin and 5 mg / mL cytarabine encapsulated in liposomes in a fixed combination in a 1:5 molar ratio . Indication : For the treatment of adults with newly diagnosed , therapy-related acute myeloid leukaemia ( t-AML ) or AML with myelodysplasia-related changes ( AML-MRC ). Dosage and administration : Treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic agents . Do not interchange Vyxeos liposomal with other daunorubicin and / or cytarabine containing products . For intravenous infusion use only . An in-line membrane filter may be used provided the minimum pore diameter is greater than or equal to 15 µ m . Do not administer via an intramuscular , intrathecal , or subcutaneous route . Refer to full SmPC for detailed information on preparation of solution for infusion . Recommended dosing schedule for induction of remission : 44 mg / 100 mg / m 2 , administered intravenously over 90 minutes on days 1 , 3 , and 5 as the first course of induction therapy ; then on days 1 and 3 as subsequent course of induction therapy , if needed . Recommended dosing schedule for consolidation : Administer first consolidation cycle 5 to 8 weeks after the start of the last induction . Recommended dosing schedule is 29 mg / 65 mg / m 2 , administered intravenously over 90 minutes on days 1 and 3 as subsequent courses of consolidation therapy , if needed . Dose adjustments during treatment may be required in hypersensitivity symptoms and cardiotoxicity . Assessment of cardiac function prior to start of treatment is recommended . Patients should be monitored for haematologic response and toxicities . Renal impairment : No dose adjustment required in mild , moderate or severe renal impairment . There
is no experience in end-stage renal disease managed with dialysis . Hepatic impairment : No dose adjustment required for bilirubin level less than or equal to 50 µ mol / L . There is no experience in hepatic impairment resulting in a bilirubin level greater than 50 µ mol / L . Elderly population ( ≥65 years ): No dose adjustment required . Contraindications : Hypersensitivity to the active substance or to any of the excipients . Special warnings and precautions : Do not substitute or interchange with other daunorubicin and / or cytarabine-containing products . Severe myelosuppression and serious or fatal haemorrhagic events have been reported . Time to recovery of ANC and platelets may be prolonged and require additional monitoring . Monitor blood counts regularly until recovery . Prophylactic anti-infectives may be administered during the period of profound neutropenia until ANC returns to 500 / μL or greater . Cardiotoxicity is a known risk ; prior therapy with anthracyclines , preexisting cardiac disease , previous radiotherapy of the mediastinum , or concomitant use of cardiotoxic products may increase the risk . Hepatic impairment may increase the risk of toxicity . Evaluation of hepatic function is recommended prior to administration and periodically during treatment . Monitor blood uric acid levels and initiate appropriate therapy if hyperuricemia develops . Each vial of Vyxeos liposomal contains 100 mg of copper gluconate . Only use in patients with a history of Wilson ’ s disease or other copperrelated disorder if the benefits outweigh the risks . Serious hypersensitivity reactions including anaphylactic reactions have been reported with daunorubicin and cytarabine . Avoid administration of live or live-attenuated vaccines . Killed or inactivated vaccines may be administered ; however , the response to such vaccines may be diminished . Gastrointestinal mucositis and / or diarrhoea frequently occur and may influence the absorption of oral accompanying medicinal products . Interactions : Do not administer in combination with cardiotoxic agents unless cardiac function is closely monitored .