Table 2 Recommendations for preventing and monitoring VOD in patients receiving InO
From: Management of important adverse events associated with inotuzumab ozogamicin: expert panel review
Preventing VOD | |
• | Avoid HCT conditioning regimens containing dual alkylating agents, thiotepa, or both |
• | Use prophylactic agents (e.g., ursodiol) |
• | When possible, avoid hepatotoxic agents (e.g., azoles) in combination with high-dose alkylator-condition administration |
• | In patients proceeding to HCT, limit treatment with InO to 2 cycles |
Monitoring for VOD | |
• | In patients who have experienced prior confirmed severe or ongoing VOD, follow recommendations in country-specific prescribing information to determine appropriate use of InO |
• | Monitor patient weight for fluid retention daily |
• | More frequently monitor LFTs and look for clinical signs and symptoms of hepatotoxicity in patients who develop abnormal LFTs |
• | Before and after each InO dose, monitor ALT, AST, total bilirubin, and alkaline phosphatase levels and adjust InO dose as recommended (Table 3) |
• | In patients proceeding to HCT, closely monitor LFTs during the first month post-HCT, then less frequently thereafter based on standard practice |