Safety profile
Doptelet is well tolerated and the most frequently reported adverse reactions (≥1/10) were headache and fatigue6
In the Phase 3 study of adult patients with chronic ITP, exposure-adjusted adverse events of Doptelet were generally comparable with placebo:1
- Any TEAE: 4.3% per patient-week vs 6.6% with placebo
- Any SAE: 1.2% per patient-week vs 0.7% with placebo
Similar AE profiles were observed across multiple studies within ITP and chronic liver disease.1–5
Doptelet is the only oral TPO-RA that has not been associated with significant hepatotoxicity in clinical trials; no liver function monitoring is required.1,6
This table is drawn up by SOBI based on table IV p 488 in ref 2
*Exposure-adjusted incidence rate = number of events/total patient-weeks exposure x 100%.1
Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo aninvasive procedure. 6
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). 6
AE, adverse event; ITP, immune thrombocytopenia; SAE, serious adverse event; TEAE, treatment-emergent adverse event; TPO-RA, thrombopoietin receptor agonist.
References
1. Jurczak W, Chojnowski K, Mayer J, et al. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br J Haematol. 2018;183(3):479-490. 2. Al-Samkari H, Jiang D, Gernsheimer T, et al. Adults with immune thrombocytopenia who switched to avatrombopag following prior treatment with eltrombopag or romiplostim: A multicentre US study. Br J Haematol. 2022;197(3):359-366. 3. Bussel JB, Kuter DJ, Aledort LM, et al. A randomized trial of avatrombopag, an investigational thrombopoietin-receptor agonist, in persistent and chronic immune thrombocytopenia. Blood. 2014;123(25):3887-3894. 4. Terrault N, Chen YC, Izumi N, et al. Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia. Gastroenterology. 2018;155(3):705-718. 5. Terrault NA, Hassanein T, Howell CD, et al. Phase II study of avatrombopag in thrombocytopenic patients with cirrhosis undergoing an elective procedure. J Hepatol. 2014;61(6):1253-1259. 6. Doptelet Summary of Product Characteristics. 22/05/2025