Doptelet has an established safety profile1,2
Adverse reactions with a frequency ≥10% in adults with chronic ITP treated with Doptelet—pooled data from clinical trials.1
| Adverse reaction | Doptelet (n=128) (%) | Placebo (n=22) (%) |
|---|---|---|
| Headache | 31 | 14 |
| Fatigue | 28 | 9 |
| Contusion | 26 | 18 |
| Epistaxis | 19 | 18 |
| Upper respiratory tract infection | 15 | 5 |
| Arthralgia | 13 | 0 |
| Gingival bleeding | 13 | 0 |
| Petechiae | 11 | 9 |
| Nasopharyngitis | 10 | 0 |
Doptelet has1-4*:
No associated liver damage*
No reported interactions with statins
No cataract precautions
What are some specific safety events to monitor for?
Thrombotic/Thromboembolic complications1
- In clinical trials in patients with chronic ITP, 7% (9/128) of patients treated with Doptelet developed a thromboembolic event
- Consider the potential increased thrombotic risk when administering Doptelet to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions and acquired risk factors
- Monitor platelet counts and follow the dosing guidelines to achieve target platelet counts. Monitor patients receiving Doptelet for signs and symptoms of thromboembolic events and institute treatment promptly
Serious adverse reactions1
- Occurred more frequently in patients with chronic ITP treated with Doptelet (9%; 12/128); included headache, occurring in 1.6% (2/128)
- Adverse reactions resulting in discontinuation of Doptelet that were reported in more than 1 patient included headache, occurring in 1.6% (2/128)
*Doptelet had no significant liver damage reported in clinical trials. Therefore, no additional liver function monitoring is required.2
ITP=immune thrombocytopenia.
Discover Doptelet dosing
See dosing and titration information for Doptelet.
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- DOPTELET (avatrombopag) [prescribing information]. Morrisville, NC: AkaRx, Inc; 2025.
- Jurczak W, Chojnowski K, Mayer J, et al. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br J Haematol. 2018;183(3):479-490.
- Bussel J, Allen LF, Aggarwal K, Vredenburg M, Tian W, Liebman W. Lack of clinically significant hepatotoxicity in patients with chronic immune thrombocytopenia treated with the novel, oral thrombopoietin receptor antagonist avatrombopag: pooled safety analysis of four clinical studies. Poster presented at: ISTH Conference 2019. July 6-10, 2019; Melbourne, Australia. Abstract PB0418.
- Data on file. Clinical study report for AVA-PED-301. 2025: Sobi, Inc.