Histamine dihydrochloride (

INN Inns are generally establishments or buildings where travelers can seek lodging, and usually, food and drink. Inns are typically located in the country or along a highway; before the advent of motorized transportation they also provided accommo ...

, trade name Ceplene) is a salt of

histamine Histamine is an organic nitrogenous compound involved in local immune responses, as well as regulating physiological functions in the gut and acting as a neurotransmitter for the brain, spinal cord, and uterus. Since histamine was discovered in ...

that is used as a

drug A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insuffla ...

for the prevention of relapse in patients diagnosed with acute myeloid leukemia (AML). It is also an FDA-approved 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 in over-the-counter (OTC) products such as Australian Dream and Golden Creme.

Use in leukemia

Histamine dihydrochloride is administered in conjunction with low doses of the immune-activating

cytokine Cytokines are a broad and loose category of small proteins (~5–25 kDa) important in cell signaling. Cytokines are peptides and cannot cross the lipid bilayer of cells to enter the cytoplasm. Cytokines have been shown to be involved in autocrin ...

interleukin-2 (IL-2) in the post-remission phase of AML, i.e. when patients have completed the initial

chemotherapy Chemotherapy (often abbreviated to chemo and sometimes CTX or CTx) is a type of cancer treatment that uses one or more anti-cancer drugs (chemotherapeutic agents or alkylating agents) as part of a standardized chemotherapy regimen. Chemotherap ...

. This combination has been reported to significantly reduce the risk of relapse in AML. The effect is particularly pronounced in patients in their first remission who are below the age of 60. The combination of histamine dihydrochloride and interleukin-2 was approved for use in AML patients within the

European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...

in October 2008 and will be marketed in the EU by the

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pharmaceutical company

Meda Meda may refer to: Places * Meda de Mouros, a parish in Tábua Municipality, Portugal * Medas, a parish in Gondomar Municipality, Portugal * Meda-Ela, Sri Lanka * Međa (Leskovac), village in the municipality of Leskovac, Serbia * Meda, Lombardy ...

. The drug is also available through a

named patient Named may refer to something that has been given a name. Named may also refer to: * named (computing), a widely used DNS server * Naming (parliamentary procedure) * The Named (band), an American industrial metal group In literature: * ''The Nam ...

program in several other countries (excluding the US).

Proposed mechanism of action

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 of

leukemic Leukemia ( also spelled leukaemia and pronounced ) is a group of blood cancers that usually begin in the bone marrow and result in high numbers of abnormal blood cells. These blood cells are not fully developed and are called ''blasts'' or ' ...

cells Cell most often refers to: * Cell (biology), the functional basic unit of life Cell may also refer to: Locations * Monastic cell, a small room, hut, or cave in which a religious recluse lives, alternatively the small precursor of a monastery w ...

. 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 transient flush and

headache Headache is the symptom of pain in the face, head, or neck. It can occur as a migraine, tension-type headache, or cluster headache. There is an increased risk of depression in those with severe headaches. Headaches can occur as a result ...

, whereas IL-2 may induce low-grade

fever Fever, also referred to as pyrexia, is defined as having a body temperature, temperature above the human body temperature, normal range due to an increase in the body's temperature Human body temperature#Fever, set point. There is not a single ...

and

inflammation Inflammation (from la, wikt:en:inflammatio#Latin, inflammatio) is part of the complex biological response of body tissues to harmful stimuli, such as pathogens, damaged cells, or Irritation, irritants, and is a protective response involving im ...

at the site of injection. Histamine dihydrochloride has been developed by researchers at the University of Gothenburg,

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References

{{Immunostimulants Immunostimulants