Revision Year: 2022 Publisher: Jazz Pharmaceuticals Ireland Ltd, 5th Floor, Waterloo Exchange, Waterloo Road, Dublin, D04 E5W7, Ireland
Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. Purple, lyophilised cake. |
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.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cytarabine |
Cytarabine (ARA-C) is metabolised in vivo to ARA-CTP phosphorylated compound. This competitively inhibits DNA polymerase and may also inhibit certain acid kinase enzymes. |
|
| Cytarabine and Daunorubicin |
Liposomal formulation of a fixed combination of daunorubicin and cytarabine in a 1:5 molar ratio. The 1:5 molar ratio has been shown in vitro and in vivo to maximise synergistic antitumour activity in acute myeloid leukaemia (AML). |
|
| Daunorubicin |
Daunorubicin is an anthracycline glycoside antibiotic and is a potent antileukaemic agent. It also has immunosuppressant effects. Daunorubicin may involve binding to DNA by intercalation between base pairs and inhibition of DNA and RNA synthesis by template disordering and steric obstruction. |
| List of Excipients |
|---|
|
Distearoylphosphatidylcholine |
50 mL vial (type 1 glass) with a stopper (chlorobutyl rubber), and an overseal (aluminium) containing 44 mg daunorubicin and 100 mg cytarabine.
Each pack contains either 1 vial, 2 vials or 5 vials. Not all pack sizes may be marketed.
Jazz Pharmaceuticals Ireland Ltd, 5th Floor, Waterloo Exchange, Waterloo Road, Dublin, D04 E5W7, Ireland
EU/1/18/1308/001 1 vial
EU/1/18/1308/002 2 vials
EU/1/18/1308/003 5 vials
Date of first authorisation: 23 August 2018
| Drug | Countries | |
|---|---|---|
| VYXEOS LIPOSOMAL | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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