Interactions : אינטראקציות

9. DRUG INTERACTIONS

9.1 Effects of Other Drugs on Bortezomib
Strong CYP3A4 inducers
Coadministration with a strong CYP3A4 inducer decreases the exposure of bortezomib [see Clinical Pharmacology (13.3)] which may decrease bortezomib efficacy. Avoid coadministration with strong CYP3A4 inducers.

Strong CYP3A4 Inhibitors
Coadministration with a strong CYP3A4 inhibitor increases the exposure of bortezomib [see Clinical Pharmacology (13.3)] which may increase the risk of bortezomib toxicities.
Monitor patients for signs of bortezomib toxicity and consider a bortezomib dose reduction if bortezomib must be given in combination with strong CYP3A4 inhibitors.

9.2 Drugs Without Clinically Significant Interactions with bortezomib No clinically significant drug interactions have been observed when bortezomib was coadministered with dexamethasone, omeprazole, or melphalan in combination with prednisone [see Clinical Pharmacology (13.3)].

During clinical trials, hypoglycemia and hyperglycemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving bortezomib treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.