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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 pivotal 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%.1
Primary Endpoint: Patients not requiring a platelet transfusion or any rescue procedure for bleeding up to 7 days following a scheduled procedure
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).1,2
88%
of high-baseline patients taking Doptelet achieved the primary endpoint (N=117)1
66%
of low-baseline patients taking Doptelet achieved the primary endpoint (N=90)1
Up to +45,000 in high-baseline patients and
+32,000 in low-baseline patients1
97% of patients whose platelet counts were measured on procedure day had an increase with Doptelet.1,3†
270/277 patients treated with Doptelet in ADAPT-1 and ADAPT-2 had increased platelet counts by procedure day.
Important Safety Information
Thrombotic/Thromboembolic Complications. 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)1,2
69%
of low-baseline patients reached the
50,000 platelets/μL target (N=90)1,2
Explore the safety profile of Doptelet
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.
- 3. Data on file. 2018: Sobi, 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
WARNINGS AND PRECAUTIONS
Thrombotic/Thromboembolic Complications. DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic complications in patients with chronic liver disease (0.4%; (1/274) in DOPTELET-treated patients) and thromboembolic complications in patients with chronic immune thrombocytopenia (7%; (9/128) in DOPTELET-treated patients). 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.
Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions.
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 for signs and symptoms of thromboembolic events and institute treatment promptly.
Serious Adverse Reactions
The most common serious adverse reaction reported in DOPTELET-treated patients compared to placebo was hyponatremia (0.7% v. 0%).
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.
These are not all the possible risks associated with DOPTELET. Please see Full Prescribing Information for DOPTELET at www.doptelethcp.com
To report suspected adverse reactions, contact Sobi North America at 1-866-773-5274 or FDA at 1-800-FDA-1088.
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.
