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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 the 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 weeks.1
8days
In only 8 days, 66% of Doptelet patients reached 50,000 platelets per microliter1
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.
- A secondary efficacy endpoint was the proportion of patients with a platelet response (platelet counts ≥50×109/L) at Day 8.
With Doptelet, nearly every patient can reach their goal3,4‡
- 94% of patients reached 50,000 platelets/μL at least once during the pivotal trial or open-label extension
- 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.4,5
Target platelet count window in pivotal trial was ≥50×109/L to ≤150×109/L.2
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).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. Dova Pharmaceuticals, 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 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 (≥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.
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 immune thrombocytopenia who have had an insufficient response to a previous treatment.
