ITP Safety

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

 

SAFETY AND TOLERABILITY PROFILE DEMONSTRATED IN MULTIPLE CLINICAL TRIALS1

Adverse reactions with a frequency ≥10% in patients with chronic ITP treated with DOPTELET® (avatrombopag)—pooled data from clinical trials*

Adverse
Reaction
DOPTELET
(N=128)
%
Placebo
(N=22)
%
Headache 31 14
Fatigue 28 9
Contusion 26 18
Epistaxis 19 18
Upper Respiratory
Tract Infection
15 5
Arthralgia 13 0
Gingival Bleeding 13 0
Petechiae 11 9
Nasopharyngitis 10 0

*The safety of DOPTELET in adults with chronic ITP was evaluated in two Phase 3 trials (one randomized, double-blind, placebo-controlled trial, and one randomized, double-blind, active-controlled trial) and two Phase 2 trials (one randomized, double-blind, placebo-controlled, dose-ranging trial and one open-label extension trial) in 161 patients with chronic ITP. Analysis included 128 patients who received 2.5 to 40 mg of DOPTELET once daily for a median exposure of 29.1 weeks, and 22 patients who received placebo for a median exposure of 5.9 weeks.1,2

Doptelet Efficacy

DOPTELET® (avatrombopag) Efficacy

Discover how DOPTELET increased platelet counts in the clinical trial.1

References:

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

2. 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.