Severe Reactions to Intravenous and Intramuscular Use
- Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of phytonadione. Reactions have occurred despite dilution to avoid rapid infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified.
- Severe reactions, including death have occurred during and immediately after IV injection.
- Events have occurred even when appropriate dilution was used to avoid rapid infusion. Some patients have exhibited symptoms on first administration of the drug.
- Majority of reports have occurred following intravenous administration, even though precautions were taken with dilution and avoidance of rapid infusion.
- Thus, restrict IV use for situations where other routes are not feasible and benefit/risk ratio is assessed and considered justified
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest.
Updated April 2018