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For US healthcare professionals only
- Important Safety Information
- Prescribing Information
- Patient Information Leaflet
- For Patients
For US healthcare professionals only
LIFT PLATELETS IN JUST 5 DAYS
Raise your patients' platelet counts with Doptelet® (avatrombopag).1*Number of days to reach treatment goal will vary.For adults with chronic liver disease (CLD) who have thrombocytopenia and are scheduled to undergo a procedure.1,2
5Days
With just 5 daily doses, Doptelet can help raise platelet counts.1†
50K
Significantly more patients taking Doptelet reached a platelet count ≥50,000/μL compared to placebo.1*
2x
On average, patients taking Doptelet nearly doubled their platelet count in time for a procedure.1
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.
Doptelet works with the body to increase platelet counts1-3
Doptelet helps provide added protection during and after the procedure
Significantly reduced the need for platelet transfusions or rescue procedures for bleeding up to 7 days post procedure.‡
Use the Doptelet Scheduling Calendar to plan your patient’s dosing start date.
A measured increase in platelet counts was observed in Doptelet treatment groups over time beginning on Day 4 post-dose, that peaked on Days 10-13, decreased 7 days post-procedure, and then returned to near baseline values by Day 35.1
On procedure day, 10 to 13 days after starting Doptelet 40 mg or Doptelet 60 mg once daily for 5 days, compared to placebo (P<0.0001; N=435).1
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
In pooled analysis of ADAPT-1 and ADAPT-2 (N=277).1
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References:
- 1. DOPTELET [package insert]. Durham, NC: AkaRx, Inc.
- 2. Data on file. 2017: Sobi, Inc.
- 3. 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
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.
