Following a full submission:
histamine dihydrochloride (Ceplene®) is not recommended for use within NHS Scotland.
Indication under review: maintenance therapy for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2. The efficacy of histamine dihydrochloride has not been fully demonstrated in patients older than age 60 years.
In a randomised open-label study, histamine plus interleukin-2 was superior to no treatment for the endpoint of leukaemia free survival (LFS) in a sub-group of patients in first complete remission. In post hoc analysis of patients in first complete remission and aged less than 60 years, LFS rates at 36 months were 50% versus 30%.
Overall the manufacturer did not present a sufficiently robust clinical or economic case to gain acceptance by SMC.
Download detailed advice133KB (PDF)
- Medicine name:
- histamine dihydrochloride (Ceplene)
- SMC ID:
- Acute myeloid leukaemia in adults at first remission
- Pharmaceutical company
- Meda Pharmaceuticals Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Not recommended
- Date advice published
- 17 January 2011