Doptelet
Pooled Doptelet safety data from ADAPT‐1 and ADAPT‐2 (N=430)1,2*
Thrombotic/Thromboembolic Complications1
- In clinical trials, 0.4% (1/274) of patients with chronic liver disease treated with Doptelet developed a treatment-emergent event of portal vein thrombosis
Serious Adverse Reactions1
- The most common serious adverse reaction reported in patients with CLD treated with Doptelet compared to placebo was hyponatremia (0.7% v. 0%)
Adverse reactions with a frequency of ≥3% adults with CLD treated with Doptelet1
| HIGH-BASELINE PLATELET COUNT COHORT (≥40 to <50 × 109/L) | LOW-BASELINE PLATELET COUNT COHORT (<40 × 109/L) | COMBINED-BASELINE PLATELET COUNT COHORTS (<50 × 109/L) | ||||
|---|---|---|---|---|---|---|
| Adverse Reaction† | Doptelet 40 mg (n=115) (%) | Placebo (n=65) (%) | Doptelet 60 mg (n=159) (%) | Placebo (n=91) (%) | Total Doptelet (N=274) (%) | Total Placebo (N=156) (%) |
| Pyrexia | 8 | 9 | 11 | 9 | 10 | 9 |
| Abdominal Pain | 7 | 6 | 6 | 7 | 7 | 6 |
| Nausea | 7 | 6 | 6 | 8 | 7 | 7 |
| Headache | 7 | 5 | 4 | 8 | 6 | 6 |
| Fatigue | 3 | 2 | 4 | 4 | 4 | 3 |
| Edema Peripheral | 4 | 2 | 3 | 2 | 3 | 2 |
Low discontinuation rates (<1%) due to
adverse reactions.1
No increase in hepatotoxicity was reported in ADAPT-1 and ADAPT-2.2
Incidence of thrombosis (1/430): In ADAPT-1 and ADAPT-2, there was one treatment-emergent event of portal vein thrombosis.1
*ADAPT-1 and ADAPT-2 were 2 identically designed, multicenter, randomized, double-blind, placebo-controlled studies.1
†Treatment-emergent adverse reactions sorted in descending order by total patients treated with Doptelet (N=274).1
- DOPTELET (avatrombopag) [prescribing information]. Durham, NC: AkaRx, Inc; 2021.
- Terrault N, Chen Y, Izumi N, et al. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018;155(3):705-718.