Apretude: PRAC reviewed with inclusion of new adverse events/warning in the SmPC

Background

Based on the assessment of the PSUR, PRAC reviewed the benefit-risk balance of Apretude, a
centrally authorised medicine containing cabotegravir and issued a recommendation on its
marketing authorisation(s).

Summary of recommendation(s) and conclusions

• Based on the review of the data on safety and efficacy, the benefit-risk balance of
  Apretude (cabotegravir) in the approved indication(s) remains unchanged.
• Nevertheless, the product information should be updated to include Stevens-Johnsons
  syndrome/toxic epidermal necrolysis (SJS/TEN) as undesirable effects with a frequency
  ‘very rare’ and a warning regarding severe cutaneous adverse reactions (SCARs). In
  addition, the product information should be updated to add gait disturbance (as a
  consequence of injection site reactions) as an undesirable effect with a frequency ‘rare’.
  Therefore, the current terms of the marketing authorisation(s) should be varied.
• In the next PSUR, the MAH should provide reviews of cases of psychosis, mood
  disorders, rhabdomyolysis, seizure and SCARs.