Interactions : אינטראקציות

4.5   Interaction with other medicinal products and other forms of interaction

No formal clinical drug-drug interaction studies with azacitidine have been conducted.
In case of concomitant administration with other antineoplastic agents, caution and monitoring is recommended as an antagonistic, additive, or synergistic pharmacodynamic effect cannot be excluded.
These effects may be dependent on the dose, sequence and schedule of administration.

Onureg exposure was minimally affected when co-administered with a proton pump inhibitor (omeprazole). Therefore, dose modification is not required when Onureg is co-administered with proton pump inhibitors or other pH modifiers.



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An in vitro study of azacitidine with human liver fractions indicated that azacitidine was not metabolised by cytochrome P450 isoforms (CYPs). Therefore, interactions with CYP inducers or inhibitors are considered unlikely (see section 5.2).
Clinically relevant inhibitory or inductive effects of azacitidine on the metabolism of cytochrome P450 substrates are unlikely (see section 5.2). No clinically relevant drug-drug interactions are expected when Onureg is co-administered with substrates of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporters (OAT) OAT1 and OAT3, organic anion transporting polypeptides (OATP) OATP1B1 and OATP1B3, or organic cation transporter (OCT) OCT2.
Azacitidine is not a substrate of P-gp, therefore it is not expected to interact with P-gp inducers or inhibitors.