Thursday, February 17, 2022

FDA approves treatment for anemia in adults with rare inherited disorder – Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA approves treatment for anemia in adults with rare inherited disorder

FDA has approved 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 (PK) deficiency.

Because of drug interactions, patients should either avoid using Pyrukynd with certain other medications or adjust the Pyrukynd dose. Abruptly stopping Pyrukynd could worsen premature red blood cell destruction. Patients should avoid suddenly stopping or pausing Pyrukynd and follow their health care provider's instructions for discontinuing treatment. 

The most common side effects of Pyrukynd are decreases in estrone and estradiol (types of the estrogen hormone) in men, increased urate (a type of salt in the body), back pain, and joint stiffness. The effects of Pyrukynd on estrone and estradiol could not be reliably assessed in women because of normal changes in these hormones during the menstrual cycle and use of hormonal contraception. 

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