A BREAKTHROUGH
IN CHEMOTHERAPY IN HIGH-RISK * AML 1
www . vyxeos . eu
* High-risk AML defined as newly diagnosed t-AML or AML-MRC † Superior overall survival vs conventional chemotherapy in patients with high-risk * AML 2
‡ Estimated from Kaplan Meier curve
International Core Prescribing Information Vyxeos ® Liposomal 44mg / 100mg powder for concentrate for solution for infusion ( Daunorubicin and cytarabine ) Please refer to the Summary of Product Characteristics before prescribing . Presentation : Purple lyophilised cake of powder for concentrate for solution for infusion . Each vial contains 44 mg of daunorubicin and 100 mg of 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 : For intravenous infusion use only . An in-line membrane filter may be used provided the minimum pore diameter of the filter is greater than or equal to 15 µ m . It must not be administered via an intramuscular , intrathecal , or subcutaneous route . Refer to the full SmPC for detailed information on preparation of solution for infusion . Treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic medicinal products . 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 : The first consolidation cycle should be administered 5 to 8 weeks after the start of the last induction . The 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 . Renal impairment : Dose adjustment is not required for patients with mild ( creatinine clearance [ CrCL ] 60 mL / min to 89 mL / min by Cockcroft Gault equation [ C-G ]) or moderate ( CrCL 30 mL / min to 59 mL / min ) renal impairment .
There is no experience in patients with severe renal impairment ( CrCL 15 mL / min to 29 mL / min ) or end-stage renal disease . It should only be used in patients with severe renal impairment if the benefits outweigh the risks . Hepatic impairment : Dose adjustment is not required for patients with a bilirubin level less than or equal to 50 µ mol / L . There is no experience in patients with hepatic impairment resulting in a bilirubin level greater than 50 µ mol / L . It should only be used in patients with severe hepatic impairment if the benefits outweigh the risks . Elderly population ( ≥65 years ): No dose adjustment is required . Paediatric population : The safety and efficacy in children aged 0 – 18 years has not yet been established . Contraindications : Hypersensitivity to the active substance or to any of the excipients . Warnings , precautions and interactions : Do not substitute or interchange with other daunorubicin and / or cytarabine-containing products . Severe myelosuppression and serious or fatal haemorrhagic events have been reported . Due to the long plasma half-life of Vyxeos Liposomal , time to recovery of ANC and platelets may be prolonged and require additional monitoring . Prophylactic anti-infectives may be administered during the period of profound neutropenia until ANC returns to 500 / μL or greater . If myelosuppressive complications occur , appropriate supportive measures should be used . Blood counts should be regularly monitored until recovery . As cardiotoxicity is a known risk prior therapy with anthracyclines , pre-existing cardiac disease , previous radiotherapy of the mediastinum , or concomitant use of cardiotoxic products may increase the risk . Hepatotoxic medicinal products may impair liver function and increase toxicity . Evaluation of hepatic and renal function is recommended prior to administration and periodically during treatment . Blood uric acid levels should be monitored and appropriate therapy initiated if hyperuricemia develops . Each vial of Vyxeos Liposomal contains 100 mg of copper gluconate . It should only be used in patients with a history of Wilson ’ s disease or other copper-related disorder if the benefits outweigh the risks . To avoid local tissue necrosis care should be taken to ensure