Table 6 Description of potential DDI risk categories [20, 21]
Risk category | Description |
|---|---|
A | Not clinically significant. Research data have not demonstrated interaction between the specified agents. |
B | Not clinically significant. There is evidence for possible interaction but little to no evidence of clinical concern resulting from concomitant use of the specified agents. |
C | Clinically significant. The benefits of concomitant use of the specified agents often outweigh the risks. An appropriate monitoring plan is required to identify potential negative effects of the interaction and dosage adjustments of one or both agents involved may be needed in some patients |
D | Clinically significant. A patient-specific assessment should be conducted to determine whether the benefits of concomitant therapy outweigh the risks. Specific actions should be taken in order to realize the benefits and/or minimize the risks i.e., aggressive monitoring, empiric dosage changes, or choosing alternative agents |
X | Clinically significant. Concomitant use of the specified agents should be avoided because the risks involved always outweigh the benefits |