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prescribing information
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prescribing information
Adverse Event Reporting details can be found at the bottom of this page
Rapid and sustained efficacy:
In the pivotal, Phase 3, randomised study:
- Doptelet patients achieved a median of 12.4 weeks at or above target platelet count without rescue therapy over 6 months*1
- 65.6% of patients on Doptelet achieved the ≥50 x 109/L platelet target by day 8*1
Effective regardless of prior treatment experience
In a retrospective observational study:
- After switching to Doptelet from another TPO-RA, 88% of primary ITP patients reached the ≥50x109/L platelet target†2
Tolerability profile comparable to placebo
- Exposure-adjusted TEAEs 4.3% per patient week vs 6.6% with placebo*1
- Doptelet is the only oral TPO-RA that has not been associated with a significant hepatotoxicity signal in ITP clinical trials; no liver function monitoring is required as standard1,3
Doptelet can be taken with any food and no liver function monitoring is required as standard3
- Doptelet should be taken at the same time of day (e.g. in the morning or evening) with food, including when taking the dose less frequently than once daily1,3–5
- No liver function monitoring is required as standard1,3
*Vs 0.0% with placebo (P<0.0001), Phase 3 study.
†This study included patients with primary or secondary ITP; the figure quoted is for the primary ITP subgroup alone.
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; 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 et al. Br J Haematol. 2022; doi:10.1111/bjh.18081. 3. Doptelet EMC Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/11837/smpc#gref Last accessed: September 2023. 4. Cheloff AZ and Al-Samkari H. J Blood Med. 2019; 10:313–321. 5. Tsykunova G and Ghanima W. Ther Clin Risk Manag. 2022; 18:273–286.
▼ 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
PP-18704