FDA Updates Lopinavir/Ritonavir (Kaletra) Labeling to Include New Drug Interaction Information

"On January 17, 2013, FDA approved revisions to the Kaletra (lopinavir/ritonavir) labels to include new drug interaction information. The following updates were included. "Anticoagulants: Rivaroxaban. Avoid concomitant use of rivaroxaban and Kaletra. Coadministration of Kaletra and rivaroxaban is expected to result in increased exposure of rivaroxaban which may led to risk of increased bleeding "Anticonvulsants: Lamotrigine and valproate. Coadministration of Kaletra and lamotrigine or valproate may decrease the exposure of lamotrigine or valproate. A dose increase of the lamotrigine or valproate may be needed when coadministered with Kaletra and therapeutic concentration monitoring for lamotrigine may be indicated; particularly during dosage adjustments. "Corticosteroids (systemic); Budesonide and prednisone. Concomitant use may result in increased steroid concentrations and reduced serum cortisol concentrations. Concomitant use of glucocorticoids that are metabolized by CYP3A, particularly for long-term use, should consider the potential benefit of treatment versus the risk of systemic corticosteroid effects. Concomitant use may increase the risk for development of systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. "HCV-Protease Inhibitor: Boceprevir. It is not recommended to coadminister Kaletra and boceprevir. Concomitant administration of Kaletra and boceprevir reduced boceprevir, lopinavir and ritonavi...