The US FDA has approved mitapivat, a pyruvate kinase activator indicated for the treatment of anemia in adults with alpha- or beta-thalassemia. Clinical evidence In clinical trials involving participants with α- or β-thalassemia, mitapivat led to higher hemoglobin response rates (42.3% vs 1.6%), greater improvements in FACIT-Fatigue scores (4.85 vs 1.46 points), and higher transfusion reduction responses (30.4% vs 12.6%) compared with placebo. Dosage and administration Available in the form of tablets The tablet should be swallowed whole.
Do not split, crush, chew, or dissolve the tablets Recommended dose is 100 mg orally twice daily with or without food Contraindications None Warnings and precautions Hepatocellular injury Adverse reactions Headache Insomnia Did you find this FDA Alert interesting? Source : FDA ##Disclaimer## The content provided on Docplexus is intended for educational…
