ITP Efficacy

For your adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment

 

HELP RAISE AND MAINTAIN PLATELET COUNTS1

Patients on DOPTELET® (avatrombopag) obtained a platelet count of ≥50×109/L for a median of 12.4 weeks without the need for rescue therapy (P<.0001 vs placebo)*

Chart: Median platelet count.
66%

of patients treated with DOPTELET achieved platelet counts of ≥50×109/L on Day 8

*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).

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.

Target platelet count window in pivotal trial was ≥50×109/L to ≤150×109/L.

§A secondary efficacy endpoint was the proportion of patients with a platelet response (platelet count ≥50×109/L) at Day 8.

Doptelet Efficacy

DOPTELET® (avatrombopag) Dosing and Titration

DOPTELET is taken with food, with no calcium or other food restrictions.1

References:

1. DOPTELET [package insert]. Durham, NC: Dova Pharmaceuticals, 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.

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 immune thrombocytopenia. Thromboembolic events (arterial and venous) have been reported in patients with chronic immune thrombocytopenia treated with TPO receptor agonists.

In clinical trials, 7% (9/128) of patients with chronic immune thrombocytopenia 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 immune thrombocytopenia in an attempt to normalize platelet counts. Follow the dosing guidelines to achieve target platelet counts.

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%) were: headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae and nasopharyngitis.

Please see Full Prescribing Information for DOPTELET® (avatrombopag).

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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 immune thrombocytopenia. Thromboembolic events (arterial and venous) have been reported in patients with chronic immune thrombocytopenia treated with TPO receptor agonists.