Mitapivat-Pyrukynd detailed instructions and instructions for use

Mitapivat (mitapivat)-Pyrukynd is an oral drug. As a pyruvate kinase activator, mitapivat helps improve the metabolism of red blood cells by enhancing the pyruvate kinase activity in red blood cells, thereby alleviating anemia, fatigue and other symptoms caused by PK deficiency. PK deficiency is a hereditary disease that results in the functional loss or abnormality of pyruvate kinase in red blood cells, which in turn leads to shortened red blood cell life, hemolytic anemia and related clinical symptoms.

1. Indications and mechanism of action

Metapival is mainly used to treat hemolytic anemia caused by pyruvate kinase (PK) deficiency in adults. This disease shortens the lifespan of red blood cells, causing symptoms of anemia. Patients often feel extremely tired and dizzy. The mechanism of action of Metapival is to increase the energy supply in red blood cells and prolong the survival time of red blood cells by activating pyruvate kinase (PK). PK deficiency reduces the synthesis of ATP (energy molecule) in red blood cells, causing premature rupture of red blood cells. Metapival restores normal ATP production, slows down the rupture of red blood cells, relieves hemolysis and improves anemia by increasing the activity of pyruvate kinase.

2. Usage and dosage

The use of mitava requires dose adjustment based on the patient's specific conditions. The patient's hemoglobin level and blood transfusion requirements usually need to be assessed regularly during treatment to determine whether the dose needs to be adjusted. Metapival should be taken as directed by your doctor. Swallow the tablet whole and do not break, crush or chew it. This medication can be taken with food or on an empty stomach.

1. Starting dose and adjustment plan: The starting dose of mitava is 5 mg twice daily. At the beginning of treatment, patients need to take this dose. As treatment progresses, doctors will adjust the dose based on the patient's hemoglobin level and hemolysis.

Weeks 1-4: Starting dose is 5 mg twice daily.

Weeks 5-8 weeks: If the hemoglobin is below the normal range or there is a need for blood transfusion in the past 8 weeks, increase the dose to 20 mg twice a day; if the hemoglobin is within the normal range and no blood transfusion is required, continue to maintain 5 mg twice a day.

No.Weeks 9-12: If hemoglobin is below the normal range or a blood transfusion has been required within the past 8 weeks, increase the dose to 50 mg twice daily, the maximum recommended dose; if hemoglobin is normal and no transfusion is required, maintain the current dose (5 mg or 20 mg twice daily).

Treatment termination criteria: If no effect is seen after 24 weeks of treatment, and the hemoglobin level and hemolysis indicators have not improved, treatment should be stopped.

2. Treatment of missed doses

If you miss a dose of Metapival and the missed dose does not exceed4 hours, you should take it as soon as possible. If you miss a dose for more than 4 hours, skip the missed dose and take the medicine on time at the next scheduled time. Patients should avoid increasing or decreasing dosage on their own to ensure consistent treatment.

3. Adverse reactions

The most common adverse reactions of metapival include laboratory abnormalities, such as decreased estrone and estradiol, increased urate, back pain, and joint pain. Additionally, some patients may experience musculoskeletal pain and other discomfort. Because the drug acts on the activity of pyruvate kinase in the body, some patients may experience slight changes in hormone levels in the body, especially male patients who may experience a decrease in estrone and estradiol. Although these side effects are usually not serious, patients should communicate with their doctor regularly so that treatment options can be adjusted in a timely manner.

4. Storage conditions

Metapival should be stored in a dry, cool place at a temperature of 20°C to 25°C, with the temperature allowed to fluctuate between 15°C and 30°C. Medications should be kept in their original packaging until use. Avoid getting the medicine damp or exposed to high temperatures to ensure the stability and effectiveness of the medicine.

Reference materials:https://www.ema.europa.eu/en/medicines/human/EPAR/pyrukynd