for oral use Initial U.S. Approval: 2022
Pyrukynd (mitapivat) tablets to treat hemolytic anemia (a disorder in which red blood cells are destroyed faster than they can be made) in adults with pyruvate kinase deficiency, an inherited disorder that causes premature red blood cell destruction.
Facts about mitapivat tablets
Approval Date: 2/17/2022
Proprietary Name: Pyrukynd
Active Ingredient(s): mitapivat
FDA-approved use: To treat hemolytic anemia in pyruvate kinase deficiency
Dosage Form: Tablet
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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Query For mitapivat tablets
Approved accessible "mitapivat tablets"
PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase. PYRUKYND is a prescription medicine used to treat low red blood cell counts caused by the early breakdown of red blood cells (hemolytic anemia) in adults with pyruvate kinase deficiency (PK Deficiency). It is not known if PYRUKYND is safe and effective in children. Active ingredient: mitapivat Inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains: FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin.
Mitapivat is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase deficiency. Mitapivat, sold under the brand name Pyrukynd, is a medication used to treat hemolytic anemia. It is taken as the sulfate hydrate salt by mouth. Mitapivat is a pyruvate kinase activator. Mitapivat was approved for medical use in the United States in February 2022, and in the European Union in November 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.
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PYRUKYND (mitapivat) tablets for oral use Initial U.S. Approval: 2022
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