Drug Interaction Report

MONITOR: Neither the leukapheresis procedure nor sipuleucel-T have been studied for use in combination with chemotherapy or immunosuppressive agents (e.g., systemic corticosteroids). Since sipuleucel-T is designed to stimulate the immune system, concurrent use of myelo- or immunosuppressive agents may alter the efficacy and/or safety of sipuleucel-T.

MANAGEMENT: Patients should be carefully evaluated to determine whether it is medically appropriate to reduce or discontinue chemotherapy or immunosuppressive agents prior to treatment with sipuleucel-T.

Food may have variable effects on the oral bioavailability of zidovudine. Fatty foods have been reported to decrease the rate and extent of zidovudine absorption following oral administration. In a study of 13 AIDS patients, mean peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) of zidovudine were 2.8 and 1.4 times higher, respectively, in fasting patients than in those administered the medication with breakfast. In addition, variations in plasma zidovudine concentrations were increased when administered in the fed state. In another study of eight patients, the time to reach peak concentration (Tmax) was increased from 0.68 to 1.95 hours, and Cmax was reduced by 50% when zidovudine was administered with a liquid high-fat meal relative to fasting. Protein meals can also delay the absorption and reduce the Cmax of zidovudine, although the extent of absorption is not significantly affected. The clinical significance of these alterations, if any, is unknown. The product labeling states that zidovudine may be taken with or without food.