Pyrukynd

Warnings and Precautions, Hepatocellular Injury in Another Condition (5.2)         01/2025

PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.

PYRUKYND is taken orally with or without food. The tablets should be swallowed whole. Do not split, crush, chew, or dissolve the tablets.

• 5 mg tablets: round, blue, film-coated tablets with "M5" printed on one side.
• 20 mg tablets: round, blue, film-coated tablets with "M20" printed on one side.
• 50 mg tablets: oblong, blue, film-coated tablets with "M50" printed on one side.

The following clinically significant adverse reaction is described elsewhere in labeling:

• Acute Hemolysis with Abrupt Treatment Discontinuation
  
  
  [see
  
  

  5.1 Acute Hemolysis with Abrupt Treatment Interruption

  Acute hemolysis with subsequent anemia has been observed following abrupt interruption or discontinuation of PYRUKYND in a dose-ranging study. Avoid abruptly discontinuing PYRUKYND. Gradually taper the dose of PYRUKYND to discontinue treatment if possible

  [see Dosage and Administration ]

  . When discontinuing treatment, monitor patients for signs of acute hemolysis and anemia including jaundice, scleral icterus, dark urine, dizziness, confusion, fatigue, or shortness of breath

  .

  5.1 Acute Hemolysis with Abrupt Treatment Interruption

  Acute hemolysis with subsequent anemia has been observed following abrupt interruption or discontinuation of PYRUKYND in a dose-ranging study. Avoid abruptly discontinuing PYRUKYND. Gradually taper the dose of PYRUKYND to discontinue treatment if possible

  [see Dosage and Administration ]

  . When discontinuing treatment, monitor patients for signs of acute hemolysis and anemia including jaundice, scleral icterus, dark urine, dizziness, confusion, fatigue, or shortness of breath

  .

  5.1 Acute Hemolysis with Abrupt Treatment Interruption

  Acute hemolysis with subsequent anemia has been observed following abrupt interruption or discontinuation of PYRUKYND in a dose-ranging study. Avoid abruptly discontinuing PYRUKYND. Gradually taper the dose of PYRUKYND to discontinue treatment if possible

  [see Dosage and Administration ]

  . When discontinuing treatment, monitor patients for signs of acute hemolysis and anemia including jaundice, scleral icterus, dark urine, dizziness, confusion, fatigue, or shortness of breath

  .

  ].
  
  
• Hepatocellular Injury in Another Condition
  
  
  [see
  
  

  5.2 Hepatocellular Injury in Another Condition

  In patients with another condition treated with PYRUKYND at a higher dose than that recommended for patients with PK deficiency, liver injury has been observed. These events were characterized by a time to onset within the first 6 months of treatment with peak elevations of alanine aminotransferase of >5×ULN with or without jaundice. All patients discontinued treatment with PYRUKYND, and these events improved upon treatment discontinuation.

  Obtain liver tests prior to the initiation of PYRUKYND and monthly thereafter for the first 6 months and as clinically indicated. Interrupt PYRUKYND if clinically significant increases in liver tests are observed or alanine aminotransferase is >5 times the upper limit of normal (ULN). Discontinue PYRUKYND if hepatic injury due to PYRUKYND is suspected.

  ]
  
  
  .