MITAPIVAT

Other

Brand names: AQVESME

Oral

Mechanism of Action

12.1 Mechanism of Action Mitapivat is a pyruvate kinase activator that acts by allosterically binding to the pyruvate kinase tetramer and increasing pyruvate kinase (PK) activity. Imbalances in globin chain production during erythropoiesis result in increased oxidative stress, which leads to ineffective erythropoiesis and hemolysis. In nonclinical models of beta-thalassemia, mitapivat improved energy homeostasis, RBC longevity, ineffective erythropoiesis, and hemolysis by increasing PK activity.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS 5
Of these 5 patients, two had serious liver injury and were hospitalized including 1 patient who developed jaundice (peak bilirubin 32 mg/dL)
AQVESME is available only through a restricted program under a REMS [see Warnings and Precautions (5
2 AQVESME REMS AQVESME is available only through a restricted program under a REMS called the AQVESME REMS because of the risk of hepatocellular injury

Known Side Effects

9 documented side effects by frequency

Fatigue

>10%

Joint Pain

1-10%

Headache

1-10%

Drug Not Working

1-10%

General Unwellness

0.1-1%

Back Pain

0.1-1%

Shortness of Breath

0.1-1%

Weakness

0.1-1%

Dizziness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral