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ACOMPLIA (RIMONABANT): DRUG INTERACTIONS

Acomplia (Rimonabant) is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in vitro. Concomitant administration of CYP3A4 inhibitors will lead to increased exposure of rimonabant. Concomitant administration of CYP3A4 inducers is expected to reduce the exposure of rimonabant.

Potential for other medicinal products to affect Rimonabant (Acomplia):

Concomitant administration of ketoconazole (a potent CYP3A4 inhibitor) increased rimonabant AUC by 104% (95% prediction interval: 40% - 197%). A similar increase in exposure is expected with other potent CYP3A4 inhibitors. Caution is advised during concomitant use of ACOMPLIA and potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, ritonavir, clarithromycin, telithromycin, nefazodone).

Although concomitant administration of CYP3A4 inducers (e.g. phenytoin, rifampicin, phenobarbital, carbamazepine, St Johnís wort) has not been studied, it is expected that concomitant administration of potent CYP3A4 inducers may reduce the plasma concentration of rimonabant and may result in loss of efficacy. Concomitant administration of orlistat, ethanol or lorazepam had no significant effect on the plasma levels of rimonabant.

Potential for Acomplia (Rimonabant) tablets to affect other medicinal products:

The in vivo inhibitory effect on CYP2C8 has not been studied. However, in vitro, rimonabant had a mild inhibitory effect on CYP2C8. The potential for inhibition of CYP2C8 in vivo appears to be low. Rimonabant does not inhibit or induce other CYP enzymes or P-glycoprotein (P-gp) in vitro. This was confirmed clinically with specific probe studies using midazolam (CYP 3A4 substrate) and warfarin (CYP 2C9 substrate) and digoxin (a P-gp substrate).

The steady-state pharmacokinetics of an ethinyl estradiol/levonorgestrel combination oral contraceptive were not significantly altered by concomitant administration of rimonabant.

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