2 Information about liposomal cytarabine–daunorubicin
Marketing authorisation indication
2.1 Liposomal cytarabine–daunorubicin (Vyxeos, Jazz Pharmaceuticals) is indicated for 'the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t‑AML) or AML with myelodysplasia-related changes (AML‑MRC)'.
Dosage in the marketing authorisation
2.2 The company's submission states that liposomal cytarabine–daunorubicin is given by intravenous infusion over 90 minutes. The dose is based on the patient's body surface area, according to the following schedule:
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For induction of remission: daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 on days 1, 3 and 5 for the first course and on days 1 and 3 for subsequent courses, if needed.
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For consolidation (5 to 8 weeks after the start of the last induction): daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 on days 1 and 3. A subsequent course of consolidation may be given when there is no disease progression or unacceptable toxicity.
Price
2.3 The company stated that the list price of liposomal cytarabine–daunorubicin is £4,581 per 50-ml vial. The company has a commercial arrangement. This makes liposomal cytarabine–daunorubicin available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.