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Doptelet

Safety profile

Doptelet is consistently well tolerated in adult patients and has no requirement for routine liver function testing as standard1

In the Phase 3 study of adult patients with primary 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

Liver icon

Doptelet has had no significant hepatoxicity signal identified in clinical trials; no liver function monitoring is required as standard.1,6

Most frequent TEAEs and SAEs during the core study1

Most frequent TEAEs and SAEs during the core study

*Exposure-adjusted incidence rate = number of events/total patient-weeks exposure x 100%.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).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 EMC Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/11837/smpc#gref Last accessed: August 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

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