ROMPAG contains eltrombopag, an oral thrombopoietin receptor agonist. It stimulates the thrombopoietin receptor signaling pathway in megakaryocyte precursor cells, promoting platelet production and increasing platelet counts in the peripheral blood.
The medication may be used in patients:
Eltrombopag has been evaluated in several major clinical studies. In a randomized clinical trial involving patients with chronic ITP, eltrombopag produced a significantly higher rate of achieving platelet counts of at least 50,000/µL compared with placebo; at the 50 mg dose, the response rate was 70% versus 11% with placebo. (PubMed)
The RAISE study also demonstrated that eltrombopag was superior to placebo in maintaining clinically meaningful platelet counts, reducing the need for rescue treatment, and lowering bleeding risk in patients with chronic ITP. (PubMed)
Long-term efficacy and safety were evaluated in the EXTEND study. In the final analysis, 85.8% of 302 patients achieved a platelet count of ≥50×10⁹/L at least once without rescue treatment, while a substantial proportion maintained responses over an extended treatment period. Bleeding symptoms also decreased during long-term therapy. (PubMed)
Eltrombopag has also been studied in severe aplastic anemia and is included in modern treatment approaches for selected patients with this condition. (FDA Access Data)
The medication is used for certain forms of thrombocytopenia, primarily chronic immune thrombocytopenia in patients who have had an insufficient response to previous treatment with corticosteroids, immunoglobulins, or splenectomy. Eltrombopag is also used for certain forms of severe aplastic anemia; exact indications depend on the patient's age and treatment regimen.
The medication is not intended simply to normalize platelet counts without a medical indication. Its primary therapeutic goal is to achieve a platelet level sufficient to reduce bleeding risk while avoiding excessive platelet elevation.
The medication is taken orally according to the physician's instructions. The tablet should be swallowed whole with water. The dose is individualized according to the underlying condition, baseline platelet count, treatment response, liver function, and concomitant therapy. Eltrombopag has important administration considerations regarding food and products containing polyvalent cations, so the prescribed administration schedule should be followed according to the official labeling for the specific product.
Side Effects
Eltrombopag requires monitoring of blood counts and liver function. Clinical studies have identified hepatotoxicity, thrombotic events, and bone marrow changes as important safety considerations.
