The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Kaletra (lopinavir/ritonavir; AbbVie) film-coated tablets and oral solution.

Kaletra, an HIV protease inhibitor, combines the antiviral drug lopinavir co-formulated with ritonavir. Ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby boosting levels of lopinavir. The approved sNDA includes updates to the Contraindications, Warnings and Precautions, Drug Interactions, Clinical Pharmacology, and the Medication Guide sections.

The Contraindications section has been updated to include the antiarrhythmic dronedarone, the anti-gout agent colchicine, and the hepatitis C direct-acting antiviral elbasvir/grazoprevir. 

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The Warnings and Precautions section includes additional information under the diabetes mellitus/hyperglycemia section to state that monitoring for hyperglycemia, new onset diabetes mellitus or an exacerbation of diabetes mellitus should be considered in patients being treated with Kaletra.

The Drug Interactions section has been updated with information on OATP1B1, isavuconazonium sulfate, and colchicine in patients with renal and/or hepatic impairment, as well as ombitasvir/paritaprevir/ritonavir and dasabuvir. Also, etravirine and rilpivirine have been added to the list of drugs under no observed or predicted interactions with Kaletra.

The drug interactions and pharmacokinetics table in the Clinical Pharmacology section has been updated with the additions of elbasvir/grazoprevir, ombitasvir/paritaprevir/ritonavir and dasabuvir, maraviroc, and tenofovir alafenamide.

Lastly, the “Who should not take Kaletra?” question under the Medication Guide was updated with the additions of dronedarone, elbasvir/grazoprevir, and colchicine. The “Tell your doctor about all the medicines you take” section was updated with the additions of isavuconazonium sulfate and ombitasvir/paritaprevir/ritonavir and dasabuvir.

Kaletra is available as 200mg/50mg and 100mg/25mg strength tablets and as a 80mg/20mL strength oral solution.

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