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 an invasive 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 et al. Br J Haematol. 2018; 183(3):479–490. 2. Al-Samkari H and Nagalla S. Platelets. 2022; 33(2):257–264. 3. Bussel JB et al. Blood. 2014; 123(25):3887–3894. 4. Terrault N et al. Gastroenterology. 2018; 155(3):705–718. 5. Terrault N et al. J Hepatol. 2014; 61(6):1253–1259. 6. Doptelet Summary of Product Characteristics. 22/05/2025