Safety Profile for Healthcare Professionals

 

DOPTELET® (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease before a scheduled procedure

DOPTELET® (avatrombopag) SAFETY PROFILE WAS SIMILAR TO PLACEBO ACROSS 2 PIVOTAL CLINICAL TRIALS

Pooled safety data from ADAPT-1 and ADAPT-2 (N=430)1*

Adverse reactions with a frequency of ≥3% in patients with CLD treated with DOPTELET

Adverse drug reactions sorted in descending order by total patients treated with DOPTELET were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

*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

Low discontinuation rates (<1%) due to adverse reactions

No increase in hepatotoxicity was reported in ADAPT-1 and ADAPT-22

Incidence of thrombosis (1/430): In ADAPT-1 and ADAPT-2 there was one treatment-emergent event of portal vein thrombosis

Doptelet Efficacy

DOPTELET® (avatrombopag) Dosing Recommendations

DOPTELET is taken once daily for 5 days with food.1

References:

1. DOPTELET [package insert]. Durham, NC: Dova Pharmaceuticals, Inc.

2. Terrault N, Chen Y-C, 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.

INDICATION

DOPTELET® (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION FOR DOPTELET

Warnings and Precautions

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET. Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

Contraindications: None

Adverse Reactions

The most common adverse reactions (≥3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

 

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INDICATION

DOPTELET® (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION FOR DOPTELET

Warnings and Precautions

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET. Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).