Doptelet
Authorised
This medicine is authorised for use in the European Union
avatrombopag
MedicineHumanAuthorised
Overview
Doptelet 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).
Doptelet contains the active substance avatrombopag.
Doptelet can only be obtained with a prescription. It is available as 20-mg tablets.
Treatment with Doptelet should start at least 10 days before the procedure. The dose is 2 or 3 tablets (depending on the platelet count at the start of treatment), daily for 5 days. A blood test on the day of the procedure is necessary to ensure that the platelet count is adequate and not unexpectedly high.
For more information about using Doptelet, 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 Doptelet, avatrombopag, attaches to the same receptors as thrombopoietin, helping to increase the platelet count.
Two main studies in 435 patients with low levels of platelets due to long-standing liver disease found Doptelet effective at increasing platelet levels before an invasive procedure. The main measure of effectiveness was the number of patients who did not require a transfusion of platelets or other treatment ('rescue procedure') to prevent excessive bleeding after starting Doptelet treatment and for up to 7 days after their invasive procedure.
In these studies, 88% of patients who received Doptelet 40 mg daily did not require a transfusion or rescue procedure compared with 36% of patients who were given placebo (a dummy treatment). Among patients with more severe thrombocytopenia, 67% of those given Doptelet 60 mg daily did not require a transfusion or rescue procedure compared with 29% of those who received placebo.
The most common side effect with Doptelet (which may affect up to 1 in 10 people) is tiredness. For the full list of side effects and restrictions with Doptelet, see the package leaflet.
Studies have found that Doptelet reduced the need for platelet transfusions or other rescue treatments to prevent excessive bleeding before an invasive procedure and for up to 7 days afterward. The platelet count increased in patients treated with Doptelet. Any unwanted effects during treatment with Doptelet were thought to result from patients’ medical condition and the nature of the invasive procedure for which it was used.
The European Medicines Agency decided that Doptelet’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 Doptelet have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Doptelet are continuously monitored. Side effects reported with Doptelet are carefully evaluated and any necessary action taken to protect patients.
Doptelet received a marketing authorisation valid throughout the EU on 20 June 2019.
Product information
Latest procedure affecting product information: IAIN/0019
04/03/2024
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
- Doptelet
- Active substance
- avatrombopag maleate
- International non-proprietary name (INN) or common name
- avatrombopag
- Therapeutic area (MeSH)
- Thrombocytopenia
- Anatomical therapeutic chemical (ATC) code
- B02BX
Pharmacotherapeutic group
AntihemorrhagicsTherapeutic indication
Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.
Doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
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