Is Mitapivat approved by the FDA?
Mitapivat (Pyrukynd) was approved by the FDA on February 17, 2022. This approval provides a much-needed treatment option for adults suffering from pyruvate kinase deficiency, helping to manage their symptoms and improve their quality of life.
How Mitapivat Works
Mitapivat works by activating the pyruvate kinase enzyme, which plays a crucial role in the glycolysis pathway that helps produce energy in red blood cells. By enhancing the function of this enzyme, Mitapivat helps stabilize red blood cells and prevent their premature destruction, thereby increasing their count in the blood.
Usage and Dosage
Mitapivat is available in various dosages, including 5 mg, 20 mg, and 50 mg oral tablets. The specific dosage and regimen will be determined by a healthcare provider based on the patient's condition and response to treatment. It can be taken with or without food, and the tablets should be swallowed whole without crushing, chewing, or breaking them.
Administration and Monitoring
Patients are advised to follow their prescription instructions carefully and not to share the medication with others. Regular follow-ups and blood tests may be required to monitor the effectiveness and adjust the dosage if necessary.
Side Effects
Mitapivat may cause various side effects, some of which can be serious. It is essential to get emergency medical help if any signs of an allergic reaction occur, such as hives, difficulty breathing, or swelling of the face, lips, tongue, or throat. Serious side effects requiring immediate medical attention include:
- Jaundice (yellowing of the skin or eyes)
- Dark urine
- Dizziness
- Confusion
- Tiredness
- Shortness of breath
Common side effects include:
- Flushing (sudden warmth, redness, or tingling feeling)
- Breast swelling and tenderness
- Changes in sexual function
- Irregular heart rhythm
- Abnormal blood tests
- Back or joint pain
Warnings and Precautions
Patients should be aware of potential serious side effects and report them to their doctor immediately. Before starting Mitapivat, patients should inform their doctor if they have a history of liver disease or if they are pregnant or breastfeeding.
Drug Interactions
Mitapivat can interact with other medications, including prescription and over-the-counter drugs, vitamins, and herbal products. It is crucial to inform the healthcare provider about all other medicines being used to avoid any adverse interactions.
Conclusion
Mitapivat (Pyrukynd) received FDA approval on February 17, 2022, for the treatment of hemolytic anemia in adults with pyruvate kinase deficiency. This medication offers a new hope for patients suffering from this condition, helping to manage symptoms and improve their overall well-being. Regular monitoring and adherence to prescribed instructions are vital for optimizing treatment outcomes and minimizing potential side effects.
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