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🏅 FDA Orphan Designation

Doptelet

avatrombopag

Manufacturer: Sobi, Inc.

Indicated for:
Immune-mediated thrombotic thrombocytopenic purpuraOrphanWiskott-Aldrich syndromeImmune thrombocytopeniaAutoimmune thrombocytopenia

FDA-Approved Indications (4)

treatment of thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

Treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure

Population: adults

Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

Population: adults

Treatment of thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

Population: pediatric ≥1 year

Indications & Usage

1 INDICATIONS AND USAGE DOPTELET is a thrombopoietin receptor agonist indicated for the treatment of: Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. ( 1.1 ) Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. ( 1.2 ) Thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment ( 1.3 ) 1.1 Treatment of Thrombocytopenia in Patients with Chronic Liver Disease (CLD) DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. 1.2 Treatment of Thrombocytopenia in Adult Patients with Chronic Immune Thrombocytopenia (ITP) DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. 1.3 Treatment of Thrombocytopenia in Pediatric Patients 1 Year and Older with Persistent or Chronic Immune Thrombocytopenia (ITP) DOPTELET is indicated for the treatment of thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.