- What is Ceplene?
- How is Ceplene used?
- How does Ceplene work?
- How has Ceplene been studied?
- What benefit has Ceplene shown during the studies?
- What is the risk associated with Ceplene?
- Why has Ceplene been approved?
- What information is still awaited for Ceplene?
- What measures are being taken to ensure the safe and effective use of Ceplene?
This is a summary of the European public assessment report (EPAR) for Ceplene. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ceplene.
What is Ceplene?
Ceplene is a solution for injection that contains the active substance histamine dihydrochloride (0.5 mg/0.5 ml).
What is Ceplene used for?
Ceplene is used in combination with
Because the number of people with AML is low, the disease is rare, and Ceplene was designated as an ‘orphan medicine’ (a medicine used in rare disease) on 11 April 2005.
The medicine can only be obtained with a prescription.
How is Ceplene used?
Ceplene should be given under the supervision of a doctor who has experience in the treatment of AML. The recommended dose of Ceplene is a
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For the first three cycles, each cycle consists of three weeks of treatment, followed by a
When Ceplene is first given, the patient’s blood pressure, heart rate and lung function must be monitored. Depending on the patient’s response to treatment and side effects, the treatment may have to be suspended or the dose adjusted.
Each Ceplene injection must be given slowly over five to 15 minutes, in a different site from the
How does Ceplene work?
The active substance in Ceplene, histamine dihydrochloride, is an immune modulator. This means that it alters the activity of the immune system (the body’s natural defences). Histamine is a naturally occurring substance in the body that is involved in many processes. In the treatment of AML, it is thought to work by protecting immune system cells from damage. This improves the effectiveness of
How has Ceplene been studied?
The effectiveness of Ceplene has been studied in one main study involving 320 adults with AML who were in remission following leukaemia treatment. Ceplene was given in combination with
What benefit has Ceplene shown during the studies?
The combination of Ceplene and
What is the risk associated with Ceplene?
The most common side effects with Ceplene (seen in more than 1 patient in 10) are upper respiratory tract infection (colds), eosinophilia (an increase in eosinophil levels, a type of white blood cell), thrombocytopenia (low blood platelet counts), headache, dizziness, dysgeusia (a bitter or unusual taste in the mouth), tachycardia (rapid heart beat), flushing (reddening), hypotension (low blood pressure), cough, dyspnoea (shortness of breath), nausea (feeling sick), dyspepsia (indigestion), diarrhoea, rash, arthralgia (pain in the joints), myalgia (muscle pain), pyrexia (fever), chills, fatigue (tiredness),
Ceplene must not be used in patients who have severe heart problems or in women who are pregnant or
or histamine H2 blockers (used to treat stomach ulcers, indigestion or heartburn). For the full list of restrictions, see the package leaflet.
Why has Ceplene been approved?
The CHMP decided that Ceplene’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Ceplene has been authorised under ‘exceptional circumstances’. This means that because the disease is rare, it has not been possible to obtain complete information about Ceplene. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
What information is still awaited for Ceplene?
The company will carry out further studies to look in more detail at the effectiveness of the combination of Ceplene and
What measures are being taken to ensure the safe and effective use of Ceplene?
A risk management plan has been developed to ensure that Ceplene is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ceplene, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Ceplene
The European Commission granted a marketing authorisation valid throughout the European Union for Ceplene on 7 October 2008.
The summary of opinion of the Committee for Orphan Medicinal Products for Ceplene can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The full EPAR for Ceplene can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Ceplene, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in