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| Clinical data | |
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| Trade names | Ceplene |
| License data | |
| Routes of administration | Subcutaneous injection,topical |
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| ECHA InfoCard | 100.000.272 |
| Chemical and physical data | |
| Formula | C5H11Cl2N3 |
| Molar mass | 184.06 g·mol−1 |
| 3D model (JSmol) | |
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Histamine dihydrochloride (trade nameCeplene) is a salt ofhistamine that is used as adrug for the prevention ofrelapse in patients diagnosed withacute myeloid leukemia (AML).
It is also an FDA-approved[1] active ingredient for topical analgesic use for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, bruises, sprains, and strains and is available inover-the-counter (OTC) products.[medical citation needed]
Histamine dihydrochloride is administered in conjunction with low doses of the immune-activatingcytokineinterleukin-2 (IL-2) in the post-remission phase ofacute myeloid leukemia (AML), i.e. when patients have completed the initialchemotherapy. This combination has been reported to significantly reduce the risk of relapse in AML.[2] The effect is particularly pronounced in patients in their first remission who are below the age of 60.[3]
The combination of histamine dihydrochloride and interleukin-2 was approved for use in AML patients within theEuropean Union in October 2008[4] and is marketed in the EU by theSwedish pharmaceutical companyMeda. The drug is also available through anamed patient program in several other countries (excluding the US).
Histamine dihydrochloride acts by improving the immune-enhancing properties of IL-2, and laboratory studies have shown that this combination can induce immune-mediated killing ofleukemiccells.[5] The treatment (in the form of subcutaneous injections) is given in 3-week cycles by the patients at home for 18 months, thus coinciding with the period of highest relapse risk. The side-effects include transientflush andheadache, whereas IL-2 may induce low-gradefever andinflammation at the site of injection. Histamine dihydrochloride has been developed by researchers at theUniversity of Gothenburg,Sweden.