Basic Information
B02BX
其它系统止血药
Antihemorrhagics
Therapeutic 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).
Overview Summary
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.
Active Substances (1)
avatrombopag maleate
Documents (14)
Doptelet-H-C-004722-P46-007 : EPAR - Assessment report - Variation
August 13, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
Doptelet : EPAR - Procedural steps taken and scientific information after the authorisation (archive)
January 27, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
Doptelet : EPAR - Procedural steps taken and scientific information after the authorisation
June 18, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Doptelet
April 26, 2019
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Doptelet : EPAR - All authorised presentations
June 25, 2019
AUTHORISED_PRESENTATIONS
CHMP post-authorisation summary of positive opinion for Doptelet (II-04-G)
December 11, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
Doptelet : EPAR - Public assessment report
June 25, 2019
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Doptelet-H-C-004722-II-0004-G : EPAR - Assessment report - Variation
January 28, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Doptelet : EPAR - Public assessment report
June 25, 2019
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Doptelet
April 26, 2019
CHANGES_SINCE_INITIAL_AUTHORISATION
Doptelet : EPAR - Medicine overview
June 25, 2019
OVERVIEW_DOCUMENT
Doptelet : EPAR - Risk-management-plan summary
June 25, 2019
RISK_MANAGEMENT_PLAN_SUMMARY
Doptelet : EPAR - Product information
June 25, 2019
DRUG_PRODUCT_INFORMATION
Doptelet-H-C-PSUSA-00010779-202005 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
April 7, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (7)
Question
What are the risks associated with Doptelet?
Answer
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.
Question
Other information about Doptelet
Answer
Doptelet received a marketing authorisation valid throughout the EU on 20 June 2019.
Question
How is Doptelet used?
Answer
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.
Question
How does Doptelet work?
Answer
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.
Question
What benefits of Doptelet have been shown in studies?
Answer
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.
Question
Why is Doptelet authorised in the EU?
Answer
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.
Question
What measures are being taken to ensure the safe and effective use of Doptelet?
Answer
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.