dosing

SAFETY PROFILE

Doptelet and Doptelet Sprinkle have no associated liver damage and no required eye exams.1-4*

Doptelet and Doptelet Sprinkle have a demonstrated safety profile1,3

WARNINGS AND PRECAUTIONS (RISK OF BLOOD CLOTS WITH TPO-RA CLASS)1

Doptelet and Doptelet Sprinkle have been associated with thrombotic and thromboembolic complications in patients with persistent or chronic ITP.

Consider the potential increased thrombotic risk when administering Doptelet and Doptelet Sprinkle to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions and acquired risk factors.

Doptelet and Doptelet Sprinkle should not be administered to patients with persistent or chronic ITP in an attempt to normalize platelet counts. Monitor platelet counts and follow the dosing guidelines to achieve target platelet counts.

Monitor patients receiving Doptelet and Doptelet Sprinkle for signs and symptoms of thromboembolic events and institute treatment promptly.

Serious adverse reactions1

Two patients experienced serious adverse reactions to Doptelet during the core phase: thrombocytosis and headache.

 
AVA1,2
PBO1,2

Any TEAE, n (%)†

Considered treatment-related by investigator

50 (92.6)
7 (13.0)
16 (76.2)
1 (4.8)
TEAE leading to study drug being withdrawn, n (%)‡
2 (3.7)
1 (4.8)

Treatment-emergent adverse events1,2

Two patients receiving treatment experienced adverse events that resulted in discontinuation: vomiting and headache in one patient, and leukocytosis in one patient.

Most common adverse reactions1,2§
AVA
PBO
Viral infectionII
20
5
Nasopharyngitis
20
10
Cough
17
0
Pyrexia
17
0
Oropharyngeal pain
13
0
*Doptelet and Doptelet Sprinkle had no significant liver damage reported in clinical trials. Therefore, no additional liver function monitoring is required.1,3,4
†The frequency of TEAEs was 92.6% over 12 weeks with Doptelet and Doptelet Sprinkle, compared to 76.2% for placebo over 6 weeks.2
‡1/21 placebo patient withdrawn due to contusion.5
§In ≥10% of Doptelet-treated patients and ≥2% more than placebo-treated patients.1
IIViral infection includes viral upper respiratory infection, viral infection, COVID-19, parainfluenza virus infection, and rhinovirus infection.1

AVA=avatrombopag; ITP=immune thrombocytopenia; PBO=placebo; TEAE=treatment-emergent adverse event; TPO-RA=thombopoietin receptor agonist.

Discover Doptelet and Doptelet Sprinkle dosing

See dosing and titration information for both tablet and oral granules.

VIEW DOSING

  1. DOPTELET (avatrombopag) [prescribing information]. Morrisville, NC: AkaRx, Inc; 2025.
  2. Data on file. Clinical study report for AVA-PED-301. 2025: Sobi, Inc.
  3. 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.
  4. 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.
  5. Grace RF, Leblebisatan G, Aydinok Y, et al; on behalf of the AVA-PED-301 Study Group. Avatrombopag for the treatment of children and adolescents with immune thrombocytopenia (AVA-PED-301): a multicentre, randomised, double-blind, placebo-controlled, phase 3b study. Lancet Haematol. 2025;12(7):e494-e504.