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.

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Medicine details

Medicine name:
histamine dihydrochloride (Ceplene)
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