Click here for United Kingdom
prescribing information
Click here for Republic of Ireland
prescribing information
Adverse Event Reporting details can be found at the bottom of this page
In a Phase III, multicentre, randomised, double-blind, parallel-group, placebo-controlled study, adult patients with chronic ITP were randomised 2:1 to Doptelet 5–40 mg once a day (n=32) or placebo (n=17). Doptelet was initiated at 20 mg once a day, and dose was titrated from days 5±1 to 28. Treatment continued until week 26, at which point eligible patients enrolled into an open-label extension phase.1
Primary endpoint: Doptelet patients (n=32) achieved a median of 12.4 weeks at or above the platelet target (≥50 × 109/L) without rescue therapy vs 0.0 weeks with placebo (p<0.0001).1
Secondary endpoint: The median platelet count was consistently higher with Doptelet vs placebo from day 8 (80.5 x 109/L vs 8 x 109/L).1
In a post-hoc subgroup analysis of the Phase III study, treatment with Doptelet was equally effective among patients with and without prior TPO-RA experience.2
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).3
ITP, immune thrombocytopenia; TPO-RA, thrombopoietin receptor agonist.
1. Jurczak W et al. Br J Haematol. 2018; 183(3):479–490. 2. McCrae KR et al. ISTH. 2019. 3. Doptelet EMC Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/11837/smpc#gref Last accessed: September 2023.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard (for United Kingdom) and www.hpra.ie (for Republic of Ireland). Adverse events should also be reported to Swedish Orphan Biovitrum Ltd at [email protected] or Telephone +44 (0) 800 111 4754