Darifenacin and Oliceridine interaction

…prolonged opioid adverse reactions and exacerbated respiratory depression, may occur when OLINVYK is used under the following conditions: In patients with decreased Cytochrome P450 (CYP) 2D6 function (poor metabolizers of CYP2D6 or normal metabolizers taking moderate or strong CYP2D6 inhibitors) [See Drug Interactions ( 7 ); Use in Specific Populations ( 8.8 )].

…oliceridine, which may lead to decreased efficacy, may occur under the following conditions: Concomitant use of OLINVYK with CYP3A4 inducers Discontinuation of a moderate or strong CYP3A4 or CYP2D6 inhibitor Closely monitor these patients at frequent intervals and consider supplemental doses of OLINVYK [see Dosage and Administration ( 2.2 ), Drug Interactions ( 7 )] .

Table 6: Clinically Significant Drug Interactions with OLINVYK Moderate to Strong Inhibitors of CYP2D6 Clinical Impact: Concomitant administration of a moderate to strong CYP2D6 inhibitor can increase the plasma concentration of oliceridine [see Clinical Pharmacology ( 12.3 )] , resulting in increased or prolonged opioid effects.

If a CYP2D6 inhibitor is discontinued, increase of the OLINVYK dosage may be considered until stable drug effects are achieved.

Inhibitors of CYP2D6: Paroxetine, fluoxetine, quinidine, bupropion Inducers of CYP3A4 Clinical Impact: The concomitant use of OLINVYK and CYP3A4 inducers can decrease the plasma concentration of oliceridine [see Clinical Pharmacology ( 12.3 )] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence…