Updated labels for Cabenuva, Apretude, Vocabria including warnings against “serious or severe hypersensitivity reactions including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)”

Updated labels for Cabenuva (Label, Letter), Apretude (Label, Letter) and Vocabria (Label, Letter) were published on the FDA website, including warnings against “serious or severe hypersensitivity reactions including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)”, which were detected as post-marketing AEs associated with cabotegravir. 

The following statements were added under the upfront ‘Warnings and Precautions’ and ‘Hypersensitivity Reaction’ sections across all labels: 

• “Serious or severe hypersensitivity reactions have been reported with cabotegravir and include Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)”.
• “Discontinue CABENUVA/APRETUDE/VOCABRIA immediately if signs or symptoms of hypersensitivity reactions develop”

The following statements were added to the ‘Patient Counselling’ section across all labels:

• “Instruct patients to immediately stop taking CABENUVA/APRETUDE/VOCABRIA and seek medical attention if they develop a rash associated with any of the following symptoms (e.g. fever, extreme tiredness, muscle/joint aches)”.
• Additional Context: SJS and TEN are rare, serious skin and mucous membrane disorders typically caused by medications, with TEN representing a more severe, life-threatening form of SJS. 
  • ViiV’s medical information portal indicates that two cases have been identified (as of October 2024), and describes the AE as “very rare”.