Inrebic

INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) ( 1 ).

None None

• Anemia and Thrombocytopenia: Manage by dose reduction, interruption, or transfusion ( 5.2 ).
• Gastrointestinal Toxicity: Manage by dose reduction or interruption if patient develops severe diarrhea, nausea, or vomiting. Prophylaxis with antiemetics and treatment with antidiarrhea medications are recommended ( 5.3 ).
• Hepatic Toxicity: Manage by dose reduction or interruption ( 5.4 ).
• Amylase and Lipase Elevation: Manage by dose reduction or interruption ( 5.5 ).
• Uveitis: Monitor for symptoms and refer for ophthalmological evaluation ( 5.6 ).
• Major Adverse Cardiac Events (MACE): Monitor for development of MACE ( 5.7 ).
• Thrombosis: Evaluate and treat symptoms of thrombosis promptly ( 5.8 ).
• Secondary Malignancies: Monitor for development of secondary malignancies, particularly in patients who are current or past smokers ( 5.9 ).
• Symptom Exacerbation Following Interruption or Discontinuation of Treatment: Manage with supportive care and consider resuming treatment with INREBIC ( 5.10 ).

5.1Encephalopathy, Including Wernicke's Serious

and fatal encephalopathy, including Wernicke's encephalopathy, has occurred in INREBIC-treated patients. Serious cases were reported in 1.3% (8/608) of patients treated with INREBIC in clinical trials and 0.16% (1/608) of cases were fatal. Wernicke's encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Signs and symptoms of Wernicke's encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia).

Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including Wernicke's, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency. However, if thiamine levels are low, replete thiamine prior to starting treatment.