Finished product reference
Eltrombopag
Tablet · Oral · 50 mg
- List code
- 51001
- Salt form
- Olamine
WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY In patients with chronic hepatitis C, Eltrombopag tablets in combination with interferon and ribavirin may increase the risk of hepatic decompensation . Eltrombopag tablets may increase the risk of severe and potentially life-threatening hepatotoxicity.
What it is and how it works
Mechanism of Action Eltrombopag is a TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor (also known as cMpl) and initiates signaling cascades that induce proliferation and differentiation of megakaryocytes leading to increased platelet production.
Indications
Eltrombopag tablets are thrombopoietin receptor agonist 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. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets 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. in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.
Dosage and administration (summary)
Take Eltrombopag tablets without a meal or with a meal low in calcium (≤ 50 mg). Take Eltrombopag tablets at least 2 hours before or 4 hours after any medications or products containing polyvalent cations, such as antacids, calcium-rich foods, and mineral supplements. ( 2.4 , 7.1 , 12.3 ) Persistent or Chronic ITP: Initiate Eltrombopag tablets at 50 mg orally once daily for most adult and pediatric patients 6 years and older, and at 25 mg orally once daily for pediatric patients aged 1 to 5 years. Dose reductions are needed for patients with hepatic impairment and some patients of East-/Southeast-Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 10 9 /L.
Contraindications
None. None.
Warnings and precautions
Hepatotoxicity: Monitor liver function before and during therapy. Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia. Thrombotic/Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving Eltrombopag tablets. Monitor platelet counts regularly. Hepatic Decompensation in Patients With Chronic Hepatitis C In patients with chronic hepatitis C, Eltrombopag tablets in combination with interferon and ribavirin may increase the risk of hepatic decompensation.
Pregnancy
Pregnancy Risk Summary Available data from a small number of published case reports and postmarketing experience with Eltrombopag tablets use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Storage and supply
Tablets The 12.5-mg tablets are Light gray to gray colored round shaped film coated tablets debossed with “12.5” on one side and “VT” on other side. Should be free from physical defects.
Source: Eltrombopag (Eltrombopag) — US FDA prescribing information, 2025-06-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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