Safety and tolerability of more than 6 days of tedizolid treatment
Mireia Mensa Vendrell 1 , Maria Tasias Pitarch 2 , Miguel Salavert Lletí 2 , Eva Calabuig Muñoz 2 , Laura Morata Ruiz 3 , Genís Castells Lao 4 , Ester López Suñé 4 , Jose Mensa Pueyo 3 , Maria Rosa Oltra Sempere 5 , Maria-Luisa Pedro-Botet Montoya 6 , Valentina Isernia 6 , Esteban Alberto Reynaga Sosa 6 , Leonor Moreno Nuñez 7 , Juan Pasquau Liaño 8 , Sergio Sequera Arquelladas 8 , José Ramón Yuste Ara 9 , Alex Soriano Viladomiu 10
Tedizolid has demonstrated its efficacy and safety in clinical trials, however, data concerning its tolerability in long-term treatments is scarce. The aim of the study was to assess the indications and to describe the long-term safety profile of tedizolid.
A multicentric, retrospective study of patients who received tedizolid for more than 6-days was conducted. Adverse events (AEs) were identified from patients' medical records and laboratory data.
The World Health Organization causality categories were used to discern AEs probably associated with tedizolid.Eighty-one patients, treated with tedizolid 200mg once-daily for a median (IQR) duration of 28 (14-59) days, were included, 36 (44.4%) had previously received linezolid. Most common reasons for selecting tedizolid were to avoid linezolid potential toxicities or interactions (53.1%) or due to previous linezolid-related toxicities (27.2%).
Most common indications were off-label, including prosthetic joint infections, osteomyelitis and respiratory infections (77.8%). Overall, 9/81 patients (11.1%) experienced a probably associated AE. Two patients (2.5%) developed gastrointestinal disorders, 1 (1.2%) anemia and 6 thrombocytopenia (7.4%) after a median (IQR) duration of treatment of 26.5 (17-58.5) days. Four (5%) patients discontinued tedizolid due to AEs.
Among 23 patients with chronic renal failure (CRF) the rate of mielotoxicity was 17.4% and only 8.7% had to stop tedizolid and 20 out of 22 with previous linezolid-associated toxicity had no AE.
Long-term tedizolid treatments had good tolerance with rates of gastrointestinal AE and hematological toxicity lower than those reported with linezolid, particularly in patients with CRF and in those with a previous history of linezolid-associated toxicity.