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

CONSISTENT EFFICACY IN 2 ROBUST STUDIES THAT INCLUDED PROCEDURES RANGING FROM LOW TO HIGH BLEEDING RISK

ELIGIBLE PROCEDURES IN THE ADAPT-1 AND ADAPT-2 STUDIES1:

  • Biliary interventions
  • Bronchoscopy +/- biopsy
  • Chemoembolization for HCC
  • Colonoscopy +/- polypectomy/biopsy
  • Dental procedures
  • Ethanol ablation
  • Laparoscopic interventions
  • Liver biopsy
  • Nephrostomy tube placement
  • Paracentesis
  • Radiofrequency ablation
  • Renal biopsy
  • Thoracentesis
  • Transjugular intrahepatic portosystemic shunt
  • Upper GI endoscopy +/- biopsy
  • Upper GI endoscopy +/- sclerotherapy
  • Upper GI endoscopy +/- variceal banding
  • Vascular catheterization

In the ADAPT studies, the percentage of patients who underwent procedures with low, moderate, or high risk was as follows: Low, 60.8%; Moderate, 17.2%; and High, 22.1%.2

ADAPT-1 and ADAPT-2 were 2 identically designed, multicenter, randomized, double-blind, placebo-controlled studies (N=435)2

ADAPT-1 and ADAPT-2 Phase III study design to evaluate the efficacy and safety of DOPTELET

DOPTELET® (avatrombopag) HELPS PROTECT PATIENTS DURING AND AFTER A SCHEDULED PROCEDURE

Significantly reduced the need for platelet transfusions or rescue procedures for bleeding for up to 7 days post procedure2*

88% of high-baseline patients and up to 69% of low-baseline patients taking DOPTELET achieved the primary endpoint (N=435)

DOPTELET HELPS PROTECT PATIENTS DURING AND AFTER A SCHEDULED PROCEDURE

Primary Endpoint: Patients not requiring a platelet transfusion or any rescue procedure for bleeding up to 7 days following a scheduled procedure2

*From randomization of DOPTELET 40 mg or DOPTELET 60 mg once daily for 5 days up to 7 days after a procedure, compared to placebo (P<.001; N=435).2

MEAN PLATELET COUNTS NEARLY DOUBLED WITH DOPTELET® (avatrombopag)

With DOPTELET, platelet counts significantly increased by procedure day2

Up to +45,000 in high-baseline patients and +32,000 in low-baseline patients2

Mean platelet counts nearly doubled with DOPTELET

97% of patients with a platelet count measured on procedure day had an increase with DOPTELET3

WITH DOPTELET® (avatrombopag), PATIENTS CAN BE READY FOR PROCEDURE DAY WITH ≥50,000/μL PLATELETS

Significantly more patients achieved a platelet count of ≥50,000/μL with DOPTELET2

Up to 93% of high-baseline patients and 69% of low-baseline patients reached the 50,000/μL target (N=435)2

WITH DOPTELET, PATIENTS CAN BE READY FOR PROCEDURE DAY WITH ≥50,000/μL PLATELETS
Doptelet Efficacy

Explore the Safety Profile of DOPTELET® (avatrombopag)

The safety profile of DOPTELET was similar to placebo.1

References:

1. 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.

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

3. Data on file. Dova Pharmaceuticals, Inc.

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).