Strong CYP3A Inducers: Avoid concomitant administration of Ninlaro with strong CYP3A inducers (such as rifampin, phenytoin, carbamazepine, and St. John's Wort) [see Pharmacology under Actions].
Strong CYP3A Inhibitors: Co-administration of Ninlaro with clarithromycin did not result in a clinically meaningful change in the systemic exposure of ixazomib.
Strong CYP1A2 Inhibitors: Co-administration of Ninlaro with strong CYP1A2 inhibitors did not result in a clinically meaningful change in the systemic exposure of ixazomib based on a population PK analysis.
Effect of Ninlaro on Other Drugs: Ixazomib is neither a reversible nor a time-dependent inhibitor of CYPs 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4/5. Ixazomib did not induce CYP1A2, CYP2B6, and CYP3A4/5 activity or corresponding immune-reactive protein levels. Ninlaro is not expected to produce drug-drug interactions via CYP inhibition or induction.
Transporter-Based Interactions: Ixazomib is a low affinity substrate of P-gp. Ixazomib is not a substrate of BCRP, MRP2 or hepatic OATPs. Ixazomib is not an inhibitor of P-gp, BCRP, MRP2, OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1, or MATE2-K. Ninlaro is not expected to cause transporter-mediated drug-drug interactions.
Oral contraceptives: When NINLARO is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters, the risk for reduced efficacy of oral contraceptives needs to be considered. Women using hormonal contraceptives should additionally use a barrier method of contraception.