Label Changes for:
Kaletra (lopinavir and ritonavir) Solution for Oral Use
Changes have been made to the CONTRAINDICATIONS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008
|The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.|
|Sections Modified||Summary of Changes to Contraindications and Warnings|
USE IN SPECIFIC POPULATIONS
PATIENT PACKAGE INSERT
Kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir.
Table 3: Drugs That Are Contraindicated With Kaletra