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This information is intended for healthcare professionals in the United States.
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NoDiscover the Doptelet Copay Program
Terms and Conditions
Doptelet is broadly available** and covered on United Healthcare, Express Scripts, CVS Caremark and Aetna.
Formulary status is subject to change and does not imply clinical efficacy or safety.††
**
Broadly available: covered for over 50% of patients on plan.
††
For specific information, please contact the patient's insurer. Individual access may vary by geography and plan benefit design. Third-party payment for prescription
drugs is affected by numerous factors, and Sobi makes no representation or guarantee concerning reimbursement or coverage for Doptelet or any other service or item.
Patients on Doptelet reached target platelet counts of 50,000/μL for a median of 12.4 cumulative weeks.1
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).
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
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
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.
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