Medical Uses
Qarziba (dinutuximab beta) is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory neuroblastoma, with or without residual disease. Before the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilized by other suitable measures.
In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first-line therapy, dinutuximab beta should be combined with interleukin-2 (IL-2).
Recommended Dosage:
Qarziba has a restriction to hospital use only, and it must be administered by a qualified physician experienced in administering oncological therapies. The healthcare professional must be capable of treating life-threatening allergic reactions such as anaphylaxis, and must be situated in a location where complete resuscitation can be provided immediately.
Treatment with Qarziba comprises five consecutive courses, each lasting 35 days. The treatment is dosed at 100 mg/m2 per course, which is further divided over the 35 days, and calculated based on body surface area.
Two modes of administration are possible:
- a continuous infusion over the first 10 days of each course (a total of 240 hours) at the daily dose of 10 mg/m2
- or five daily infusions of 20 mg/m2 administered over 8 hours, on the first 5 days of each course.
When IL-2 is combined with Qarziba, it should be administered as subcutaneous injections of 6×106 IU/m2 /day, for 2 periods of 5 consecutive days, resulting in an overall dose of 60×106 IU/m2 per course. The first 5-day course should start 7 days before the first infusion of dinutuximab beta, and the second 5-day course should start concurrently with dinutuximab beta infusion (days 1 to 5 of each dinutuximab beta course).