You are about to leave doptelethcp.com and go to an external page.
Please note that Sobi is not responsible for the content of the website you are about to visit.
CONTINUEGo back
You are about to leave doptelethcp.com and go to an external page.
Please note that Sobi is not responsible for the content of the website you are about to visit.
CONTINUEGo back
This information is intended for healthcare professionals in the United States.
Are you a healthcare professional?
Yes
NoDiscover the Copay Assistance Program
Terms and Conditions
DOPTELET IS THE FASTEST-GROWING TPO-RA1**
Based on year-over-year financial market growth data for TPO-RAs from fiscal year 2021 compared to fiscal year 2022.1
Reference: 1. Data on file. TPO-RA Market Growth. 2023: Sobi, Inc.
DOPTELET NOW HAS PARITY ACCESS WITH ELTROMBOPAG AT SOME OF THE LARGEST COMMERCIAL PLANS1
Use our look-up tool to see if your commercial plan is eligible for Doptelet.
Reference: 1. Data on file. CAM Conversion Guide. 2022: Sobi, Inc.
Food required.
Platelet monitoring required. After initiating therapy with Doptelet, assess platelet counts weekly until a stable platelet count of ≥50x109/L has been achieved, and then obtain platelet counts monthly thereafter.
Rapid and durable response in the 6-month core study:
In the pivotal trial and open-label extension:
With Doptelet, keep platelet counts lifted at 50,000/μL.1‡
Patients on Doptelet reached target platelet counts of 50,000 platelets/μL for a median of 12.4 cumulative weeks.1
Most patients reached 50,000 platelets/μL in as few as 8 days with Doptelet.1§
In the pivotal trial and open-label extension:
94% of patients reached 50,000 platelets/μL at least once in Doptelet clinical trials.3||
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).
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 15 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.2,4
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.
Patients can take Doptelet with any food (food required); no administration concerns with minerals like calcium or magnesium.1
Doptelet does not require additional liver-function monitoring; no significant hepatotoxicity seen in Doptelet clinical trials.1,2
Doptelet can be taken anytime, anywhere, without adding trips to the doctor (platelet monitoring required).1†
Food required.1
Platelet monitoring required. After initiating therapy with Doptelet, assess platelet counts weekly until a stable platelet count of ≥50x109/L has been achieved, and then obtain platelet counts monthly thereafter.1
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.2,4
Study Design: 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).1
Exploratory endpoints were reported in an integrated analysis of the Phase 3 Core Study and Extension Phase data. Patients could enter the 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 open-label titrated Doptelet. Thirty-nine patients entered the Extension Phase (24 Doptelet and 15 placebo).3,4
Doptelet Patient Experience
To see more videos on Doptelet, visit our video library.
TPO-RA=thrombopoietin receptor agonist.
Avatrombopag was not studied as part of the 2019 ASH guidelines.
Our support specialists can help answer your questions about Doptelet and access options —
call 833-368-2663.
Monday–Friday 8 AM–8 PM ET.
Doptelet worked to raise platelet counts in patients with ITP in the Phase 3 clinical study. Ready to see the numbers?1†
View EfficacyINDICATION
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.
This website uses cookies. By continuing to use this website, you consent to our use of these cookies.