Aggiornate le schede tecniche dei seguenti farmaci: Dovato, Tivicay, Triumeq

Scope of the update

Update of section 4.8 of the SmPC to add “completed suicide” to the list of adverse drug reactions (ADRs) with frequency ”rare” in the dolutegravir (Tivicay), dolutegravir/ abacavir/lamivudine (Triumeq) and dolutegravir/lamivudine (Dovato) following the finalisation of PSUSA procedure EMEA/H/C/PSUSA/00010075/202101 (reporting period 17 Jan 2020 to 16 Jan 2021) based on reports of completed suicide from participants exposed to dolutegravir containing regimen in ViiV Healthcare-sponsored clinical trials. As the changes impact all dolutegravir containing products, the MAH submitted a worksharing procedure to include Dolutegravir/Rilpivirine (Juluca) product in accordance with Article 20 (worksharing procedure) of Commission Regulation (EC) 1234/2008. The Package Leaflet is updated in section 4 with a rather identical wording. The proposed wording should be as follows (identical with the suggested wording by the MAH regarding Dovato (footnote instead of brackets for the explanatory wording is acceptable to be in line with already included footnote on suicidal ideation and suicide attempt), Triumeq and Juluca. Nevertheless, the wording in section 4 for Tivicay is not exactly the same as for the other three products and should be therefore adapted accordingly). Furthermore, it could be considered to add a statement for patients in section of the PL that they should consult their doctor especially if neuropsychiatric side effects occur, since only under this condition an adequate reaction by the HCPs (knowledge of the adverse effects) is possible.