FDA label
What is Promacta used for?
Promacta contains eltrombopag olamine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Promacta lists 3 uses: Treatment of Thrombocytopenia in Patients With Persistent or Chronic Immune Thrombocytopenia; Treatment of Thrombocytopenia in Patients With Hepatitis C Infection; Treatment of Severe Aplastic Anemia.
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Promacta, tablet, film coated
Indications and Usage, quoted from the label by Novartis Pharmaceuticals Corporation (NDA022291). Cross-references to other label sections are left out.
Treatment of Thrombocytopenia in Patients With Persistent or Chronic Immune Thrombocytopenia
PROMACTA is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
Treatment of Thrombocytopenia in Patients With Hepatitis C Infection
PROMACTA is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.
Treatment of Severe Aplastic Anemia
- PROMACTA is indicated in combination with standard immunosuppressive therapy (IST) for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.
- PROMACTA is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
Limitations of Use
- PROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (MDS).
- Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.
Source: DailyMed label, set id 7714a0ed-34bb-46e6-a0a5-b363908b22c2, version 31, effective December 18, 2025. NDC 0078-0684, one of 4 listings for this product.
Questions
What is Promacta used for?
The FDA label for Promacta lists 3 uses: Treatment of Thrombocytopenia in Patients With Persistent or Chronic Immune Thrombocytopenia; Treatment of Thrombocytopenia in Patients With Hepatitis C Infection; Treatment of Severe Aplastic Anemia.
What drug class is Promacta?
FDA lists eltrombopag olamine in the Thrombopoietin Receptor Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Promacta
- Is Promacta a controlled substance?Federal schedule
- Generic for PromactaFDA Orange Book
- Generic for Promacta KitFDA Orange Book
- Thrombopoietin Receptor Agonists listFDA drug class
- Promacta Medicare Part D coverageBy plan and state
- NDC 0078-0684Promacta NDC record
- NDC 0078-0685Promacta NDC record
- NDC 0078-0686Promacta NDC record