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prescribing information
Adverse Event Reporting details can be found at the bottom of this page
Speed of onset and sustainability of response
Doptelet helps get patients to the ≥50 x 109/L target within 8 days, and keeps them there for months*1,2
The efficacy and safety of Doptelet in adult patients with chronic ITP was evaluated in a Phase 3, multicentre, randomised, double-blind, parallel-group, placebo-controlled study.1
*At EOT visit (visit 22), patients could enter the extension phase. Patients not continuing entered the dose-tapering and follow-up phase.1
†For patients who did not enter the extension phase.1 ‡Optional entry into the open-label extension phase.1 §The screening visit and day 1 baseline/randomisation visit platelet counts were averaged to obtain the baseline platelet count value.1 IIPatients who discontinued early who met the criteria for a lack of treatment effect may have moved directly into the open-label extension phase.1
- Primary endpoint: Cumulative number of weeks of platelet response, defined as platelet count ≥50 x 109/L in the absence of rescue therapy over 6 months of once-daily treatment1
- Secondary endpoint: The proportion of patients with platelet response at day 8 and the proportion of patients with a reduction in the use of concomitant ITP medications from baseline1
*Significantly more Doptelet patients achieved response by month 6 (87.5% vs. 5.9% placebo; P<0.0001).2
†Defined as a platelet count ≥50 x 109/L in the absence of rescue therapy. ‡Vs 0.0 with placebo (P<0.0001).1
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; CONMED, concomitant medication; DOP, Doptelet; EOT, end-of-treatment; ITP, immune thrombocytopenia; qd, once daily; R, randomisation
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. Doptelet EMC Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/11837/smpc#gref Last accessed: April 2025.
Doptelet is a registered trademark of AkaRx, Inc., a Sobi company. Sobi is a trademark of Swedish Orphan Biovitrum AB (publ) © 2025 Sobi, Inc. – All rights reserved.
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App
Store (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