Mulpleo (previously Lusutrombopag Shionogi)
Authorised
This medicine is authorised for use in the European Union
lusutrombopag
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Mulpleo is a medicine used to prevent excessive bleeding in adults with thrombocytopenia due to long-standing liver disease. Patients with thrombocytopenia have reduced number of platelets (components in the blood that help it to clot), which can cause excessive bleeding.
The medicine is for use in patients having an invasive procedure (a medical procedure that involves cutting into or puncturing the skin or inserting instruments into the body).
Mulpleo contains the active substance lusutrombopag.
Mulpleo is available as 3 mg tablets. The medicine can only be obtained with a prescription.
Treatment with Mulpleo should start at least 8 days before the procedure and the recommended dose is 1 tablet daily for 7 days.
For more information about using Mulpleo, see the package leaflet or contact your doctor or pharmacist.
In the body, a hormone called thrombopoietin stimulates the production of platelets by attaching to receptors (targets) in the bone marrow. The active substance in Mulpleo, lusutrombopag, attaches to the same receptors as thrombopoietin, helping to increase the platelet count.
In two main studies involving adults with low levels of platelets due to long-standing liver disease, Mulpleo increased platelet count before an invasive procedure and reduced the need for transfusions.
The first study, involving 96 adults, found that 79% of patients who took Mulpleo did not require a transfusion of platelets before their procedure, compared with 13% of patients who received placebo (a dummy treatment). The second study involving 215 adults found that 65% of patients who took Mulpleo did not require platelet transfusion before their procedure, compared with 29% of patients who received placebo.
Unwanted effects that occurred in studies involving patients taking Mulpleo were headache, nausea (feeling sick), portal vein thrombosis (a blockage in the blood vessel that carries blood from the intestines to the liver) and rash. Similar effects occurred in patients receiving placebo.
For more information on the side effects and restrictions of Mulpleo, see the package leaflet.
Studies have found that Mulpleo increases platelet count, thereby lowering the risk of excessive bleeding during or after an invasive procedure and reducing the need for transfusing platelets. Unwanted effects that occurred in studies are thought to result from patients’ medical condition and the nature of the invasive procedure for which Mulpleo was used.
The European Medicines Agency decided that Mulpleo’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mulpleo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Mulpleo are continuously monitored. Side effects reported with Mulpleo are carefully evaluated and any necessary action taken to protect patients.
Mulpleo received a marketing authorisation valid throughout the EU on 18 February 2019.
Product information
Latest procedure affecting product information:
IAIN/0017/G
05/01/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Mulpleo (previously Lusutrombopag Shionogi)
- Active substance
- Lusutrombopag
- International non-proprietary name (INN) or common name
- lusutrombopag
- Therapeutic area (MeSH)
- Thrombocytopenia
- Anatomical therapeutic chemical (ATC) code
- B02BX
Pharmacotherapeutic group
AntihemorrhagicsTherapeutic indication
Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures
News on Mulpleo (previously Lusutrombopag Shionogi)
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