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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
Dosing
An oral TPO-RA taken with any food1,2
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 daily.
Doptelet meets patient preference for an oral treatment taken with any type of food1-3
The TRAPeze study is an ongoing pan-European, cross-sectional, exploratory, observational study that aims to explore patients’ experiences with TPO-RAs and their preferences towards TPO-RA treatment attributes. Included are results from the UK and Ireland cohort of the TRAPeze study, consisting of 32 people with ITP who had been treated with eltrombopag or romiplostim (the only TPO-RAs available at the time of the study). The survey consisted of two sections on treatment preference and disease burden. The treatment preference section consisted of 10 sets of scenarios, each requiring participants to choose between two hypothetical treatment scenarios that correspond to different TPO-RA attributes. The disease burden section consisted of 101 questions on demographics, disease characteristics, treatment history, overall satisfaction with therapy, impact of ITP on work, productivity, personal life and healthcare resource utilisation.3
International guidelines recommend considering patient preference, adherence, and impact on quality of life when it comes to treatment choice.4–6
In the TRAPeze study, adult patients with chronic ITP were:
7x more likely to choose oral treatment vs injection3
4x more likely to choose oral treatment with no food-type restrictions vs with3
One dosage strength for manageable adjustment1
Begin at 20 mg once daily and titrate up and down as needed, based on your patient’s platelet count.1
After initiating therapy, assess platelet counts at least once weekly until a stable platelet count ≥50 × 109/L and ≤150 × 109/L has been achieved. Twice weekly platelet count monitoring should be conducted during the first weeks of therapy in patients receiving Doptelet only once or twice weekly. Twice weekly monitoring should also be conducted after dose adjustments during the treatment. Due to the potential risk of platelet counts above 400 x 109/L within the first weeks of treatment patients should be carefully monitored for any signs or symptoms of thrombocytosis. After a stable platelet count has been achieved, obtain platelet counts at least monthly. After discontinuation of Doptelet, platelet counts should be obtained weekly for at least 4 weeks.1
†Initial dose regimen for all patients except those taking moderate or strong dual inducers or moderate or strong dual inhibitors of CYP2C9 and CYP3A4/5, or of CYP2C9 alone.1 ‡Discontinue if platelet count >250 x 109/L after 2 weeks of Doptelet 20 mg once a week. Discontinue if platelet count <50 x 109/L after 4 weeks of Doptelet 40 mg once daily. Please consult Doptelet SmPC for full information on dose adjustments.
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).1
AVA, avatrombopag; ELT, eltrombopag; ITP, immune thrombocytopenia; TPO-RA, thrombopoietin receptor agonist.
References
1. Doptelet EMC Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/11837/smpc#gref Last accessed: September 2023. 2. Jurczak W et al. Br J Haematol. 2018; 183(3):479–490. 3. McDonald V et al. Hematology. 2021; 26(1): 799–808. 4. Matzdorff A et al. Oncol Res Treat. 2018; 41 Suppl 5:1–30. 5. Neunert CE et al. Blood Adv. 2019; 3(23):3829–3866. 6. Provan D et al. Blood Adv. 2019; 3(22):3780–3817.
▼ 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-18709