HIV/AIDS Update - Kaletra (lopinavir/ritonavir) label update: 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 ritonavir steady-state exposures
HCV-Protease Inhibitor: Telaprevir. It is not recommended to coadminister Kaletra and telaprevir. Concomitant administration of Kaletra and telaprevir reduced steady-state telaprevir exposure, while the steady-state lopinavir exposure was not affected.
Inhalded or Intransal Steroids: e.g. Budesonide: Concomitant use of Kaletra and fluticasone or other glucocorticoids that are metabolized by CYP3A is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects. Concomitant use may result in increased steroid concentrations and reduce serum cortisol concentrations. Systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression have been reported during postmarketing use in patients when certain ritonavir-containing products have been coadministered with fluticasone propionate or budesonide.
PDE5 Inhibitors: Avanafil. Do not use Kaletra with avanafil
because a safe and effective avanafil dosage regimen has not been
Drug interaction or clinical studies reveal no clinically significant interaction between Kaletra and raltegravir.
The updated labeling will be made available through Drugs@FDA.
Kaletra is a product of Abbott Laboratories.
Office of Special Health Issues
Food and Drug Administration
Division of Antiviral Products
Food and Drug Administration
Posted: January 2013
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