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For US healthcare professionals only
- Important Safety Information
- Prescribing Information
- Patient Information Leaflet
- For Patients
For US healthcare professionals only
RAISE & MAINTAIN
Platelet counts
Doptelet® (avatrombopag) is a fast-acting, long-lasting TPO-RA for ITP.1,2*
Rapid onset with Doptelet1
Patients on Doptelet reached target platelet counts of 50,000/μL for a median of 12.4 cumulative weeks.1
8days
In as few as 8 days, 66% of Doptelet patients reached 50,000 platelets per microliter1
Core Study: Efficacy was evaluated in a 6-month, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. Patients had previously received one or more prior chronic ITP therapies and had average screening and baseline platelet counts of <30×109/L. Forty-nine patients were randomized (2:1) to receive either Doptelet (n=32) or placebo (n=17).
- The primary efficacy endpoint was the cumulative number of weeks of platelet response, defined as a platelet count ≥50×109/L in the absence of rescue therapy, over 6 months of once-daily treatment in adults with chronic ITP. Doptelet-treated patients had a median duration of 12.4 cumulative weeks vs 0 weeks for placebo
- A secondary efficacy endpoint was the proportion of patients with a platelet response (platelet counts ≥50×109/L) at Day 8. 66% (n=21/32) of Doptelet-treated patients had platelet counts of ≥50,000/μL at Day 8 compared to placebo (n=0/17)
Open-label extension: Patients could enter the open-label extension phase if they completed the 6-month core study, or if they experienced a lack of efficacy during that period. In the extension phase, all patients received titrated Doptelet once daily. Thirty-nine patients (24 Doptelet and 14 placebo) entered the 90-week maintenance period of the extension phase, in which Doptelet dose titration and downward titration of concomitant ITP medications were allowed. At the end of the extension phase, a 4-week, dose-tapering period was followed by a 30-day follow-up after the last dose of Doptelet.2
- The primary endpoint of the extension study was to assess the long-term safety and efficacy of treatment with Doptelet by measuring platelet response rate, bleeding, and the use of rescue therapy2
- Exploratory endpoints included the percentage of patients who achieved platelet counts ≥50,000/μL or ≥100,000/μL at any time during the core study and its extension phase. These endpoints were reported in an integrated analysis of the Phase 3 core study and extension phase data. In an integrated analysis of the core study and its extension phase, 93.8% of patients initially randomized to Doptelet and who continued to be treated with Doptelet during the extension phase achieved a platelet count of ≥50,000/μL at any time, compared to 64.7% of placebo patients who rolled-over to Doptelet.4,5
With Doptelet, nearly every patient can reach their treatment goal3,4
- 94% of patients reached 50,000 platelets/μL at least once during the pivotal trial or open-label extension‡
- The study was not placebo-controlled; therefore, causality cannot be attributed, and hypothesis testing cannot determine whether within-arm changes were due to drug effect. The Extension Study may not meet the FDA definition of an adequate and well-controlled study due to its study design
- 38% of patients reached a complete response by Day 8 of 100,000 platelets/μL (N=32)
- Platelet counts remained above baseline for more than a year with Doptelet2
Throughout the core study and extension phase, 72.3% of patients were exposed to avatrombopag for at least 32 weeks. In the open-label extension phase for those patients continuing Doptelet treatment, a response was achieved at 44.2% of visits.2,5
Target platelet count window in pivotal trial was ≥50×109/L to ≤150×109/L.2
In an integrated analysis of the core study and its open-label extension phase, 93.8% of patients initially randomized to Doptelet achieved a platelet count of ≥50,000/μL at any time, and 64.7% of placebo patients who rolled-over to Doptelet in the open-label extension phase also reached this metric.4,5
See Dr. Steven Fein discuss Doptelet® (avatrombopag) ITP study results
Dr. Steven Fein, MD, MPH
Founder/President of Heme Onc Call
Visit the video library to view more presentations.
View Discussion
Visit the video library to view more presentations.
View DiscussionReferences:
- 1. DOPTELET [package insert]. Durham, NC: AkaRx, Inc.
- 2. Jurczak W, Chojnowski K, Mayer J, et al. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br J Haematol. 2018;183(3):479-490.
- 3. Data on file. 2014: Sobi, Inc.
- 4. Nagalla S, Vredenburg M, Tian W, Allen LF. Platelet response to avatrombopag in patients with chronic immune thrombocytopenia: additional analyses from a phase 3 study and its extension. Blood. 2019;134(suppl 1):1071.
- 5. Al-Samkari H, Aggarwal K, Vredenburg M, Tian W, Allen LF. Long-term response rates in patients with chronic immune thrombocytopenia treated with avatrombopag: additional analyses from a phase 3 study and its extension phase. Blood. 2019;134(suppl 1):2356.
INDICATION
DOPTELET® (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
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
Serious adverse reaction that occurred more frequently in patients treated with DOPTELET (9%; 12/128) compared to placebo (5%; 1/22) was headache, occurring in 1.6% (2/128).
Adverse Reactions
The most common adverse reactions (≥10%) in patients with chronic immune thrombocytopenia were headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.
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 immune thrombocytopenia who have had an insufficient response to a previous treatment.
