Alvaiz FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 9, 2024.
FDA Approved: Yes (First approved November 29, 2023)
Brand name: Alvaiz
Generic name: eltrombopag choline
Dosage form: Tablets
Company: Teva Pharmaceuticals USA, Inc.
Treatment for: Thrombocytopenia, Aplastic Anemia
Alvaiz (eltrombopag choline) is thrombopoietin receptor agonist used for the treatment of thrombocytopenia and aplastic anemia.
- Alvaiz is indicated:
- for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Alvaiz 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 adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Alvaiz 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 interferonbased therapy.
- for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
Limitations of Use: Alvaiz is not indicated for the treatment of patients with myelodysplastic syndrome (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. - Eltrombopag is a thrombopoietin (TPO) receptor agonist that works to increase platelet production by interacting with the transmembrane domain of the human TPO-receptor to initiate signaling cascades that induce proliferation and differentiation of megakaryocytes.
- Eltrombopag was first approved under the brand name Promacta (eltrombopag olamine) in 2008. Alvaiz (eltrombopag choline) is not substitutable with Promacta products on a milligram per milligram basis.
- Alvaiz is administered orally, once daily.
- Warnings and precautions associated with Alvaiz include hepatotoxicity, increased risk of death and progression of myelodysplastic syndromes to acute myeloid leukemia, and thrombotic/thromboembolic complications.
- Common adverse reactions include anemia, nausea, pyrexia, cough, fatigue, headache, diarrhea, and increased alanine aminotransferase.
Further information
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