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For US healthcare professionals only
- Important Safety Information
- Prescribing Information
- Patient Information Leaflet
- For Patients
For US healthcare professionals only
CONSISTENT EFFICACY
In 2 robust studies that included procedures ranging from low to high bleeding risk.1
ADAPT‐1 and ADAPT‐2 were 2 identically designed, multicenter, randomized, double‐blind, placebo‐controlled studies (N=435)1,2
- 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
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<0.0001; N=435).2
88%
of high-baseline patients taking Doptelet achieved the primary endpoint (N=117)
66%
of low-baseline patients taking Doptelet achieved the primary endpoint (N=90)
Up to +45,000 in high-baseline patients and
+32,000 in low-baseline patients2
97% of patients whose platelet counts were measured on procedure day had an increase with Doptelet
Important Safety Information
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.
Doptelet should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.
93%
of high-baseline patients reached the
50,000 platelets/μL target (N=58)
69%
of low-baseline patients reached the
50,000 platelets/μL target (N=90)
Explore the safety profile of Doptelet
The safety profile of Doptelet® (avatrombopag) was similar to placebo.1
DOPTELET SAFETY PROFILE
References:
- 1. DOPTELET [package insert]. Durham, NC: AkaRx, 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 or chronic immune thrombocytopenia. Portal vein thrombosis has been reported in patients with chronic liver disease, and thromboembolic events (arterial and venous) have been reported in patients with chronic immune thrombocytopenia treated with TPO receptor agonists.
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. In clinical trials in patients with chronic immune thrombocytopenia, 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 (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).
DOPTELET should not be administered to patients with chronic liver disease or chronic immune thrombocytopenia in an attempt to normalize platelet counts. 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.
Contraindications: None
Drug Interactions
Dose adjustments are recommended for patients with chronic immune thrombocytopenia taking moderate or strong dual CYP2C9 and CYP3A4 inducers or inhibitors.
Adverse Reactions
The most common adverse reactions (≥3%) in patients with chronic liver disease were: pyrexia, abdominal pain, nausea, headache, fatigue, and peripheral edema.
Postmarketing Experience
Following the approval of DOPTELET, hypersensitivity reactions involving the immune system, including, but not limited to, pruritus, rash, choking sensation, swollen face, and swollen tongue have been reported.
Please see Full Prescribing Information for DOPTELET (avatrombopag) at doptelet.com
For WAC pricing, visit doptelethcp.com/wac-pricing.
INDICATION
DOPTELET® (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with:
• Chronic liver disease who are scheduled to undergo a procedure.
