Kaletra Label Updated to Add Drug Interactions, Including Boceprevir and Telaprevir

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Product label information for the HIV protease inhibitor lopinavir/ritonavir (Kaletra) was revised to include information about several additional medications with the potential for drug-drug interactions, the U.S. Food and Drug Administration (FDA) announced last week.

Among these are the systemic corticosteroids budesonide and prednisone, and the recently approved hepatitis C virus (HCV) protease inhibitors boceprevir (Victrelis) and telaprevir (Incivek).

Below is an edited excerpt from the recent FDA press release describing the changes.

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.

Inhaled 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 established.

Drug interaction or clinical studies reveal no clinically significant interaction between Kaletra and raltegravir [Isentress, and HIV integrase inhibitor].

The updated labeling will be made available through Drugs@FDA.

1/24/13

Source

R Klein and K Struble, Food and Drug Administration. Kaletra (lopinavir/ritonavir) label update: drug interaction information. HIV/AIDS Update. Press release. January 22, 2013.