The Food and Drug Administration (FDA) has approved labeling updates for Kaletra (lopinavir/ritonavir; AbbVie) tablet and oral solution.
Under Dosage and Administration, the update states that because Kaletra oral solution contains ethanol, it is not recommended for use with polyurethane feeding tubes due to potential incompatibility.
Ranolazine, an antianginal drug, has been added as a new contraindication. The labeling states that concomitant use has potential for serious and/or life-threatening reactions.
Under Drug Interactions, a new anticancer agent (eg, venetoclax) and systemic/inhaled nasal/ophthalmic corticosteroids (eg, betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, prednisone, triamcinolone) were added. Coadministration of venetoclax and Kaletra may increase the risk of tumor lysis syndrome. Coadministration with with oral dexamethasone or other systemic corticosteroids that are CYP3A inducers may result in loss of therapeutic effect and development of resistance to lopinavir; alternative corticosteroids should be considered.
Coadministration with corticosteroids whose exposures are potentiated by strong CYP3A inhibitors can increase the risk for Cushing’s syndrome and adrenal suppression. The labeling states that alternative corticosteroids whose pharmacokinetic and pharmacodynamic profiles are less affected by strong CYP3A inhibitors (eg, beclomethasone, prednisolone) should be considered especially for long-term use.
The Medication Guide has also been updated to reflect these changes.
Kaletra, a protease inhibitor, is currently indicated to treat HIV-1 infection in combination with other antiretroviral agents. It is supplied as 100mg/25mg and 200mg/25mg strength tablets as well as a 80mg/20mg per mL oral solution.
For more information call (800) 633-9110 or visit Kaletra.com.