FARMACIA HOSPITALARIA最新文献

Introduction: Bruton's tyrosine kinase inhibitors (BTKi) have replaced immunochemotherapy in patients with chronic lymphocytic leukemia (CLL). The safety profile, particularly in monotherapy indications under real-world clinical practice conditions, is key to optimizing outcomes.

Objective: To describe the safety and tolerability of continuous/indefinite BTKi therapy in patients with CLL treated in the first line and relapse/refractory (R/R) conditions with BTKi monotherapy, within labeled indications, at a tertiary care hospital.

Methods: Observational, retrospective, single-centre study including patients with CLL treated with iBTK (2015-2024). Demographic data, previous lines of treatment, dose adjustments and suspensions, and adverse events (AEs) by system and severity were recorded. Proportions were compared using Fisher's exact test. Treatment continuation was analyzed using Kaplan-Meier curves, log-rank tests, and Cox regression.

Results: Eighty-three patients (50.6% male) were included, with a mean age at diagnosis of 67.2 years. Forty-eight (58%) received iBTK as first-line therapy and 35 (42%) in R/R. The most commonly used iBTK was ibrutinib (62.5% in first-line and 88.6% in R/R). Median follow-up was 20.8 months. Overall, 28,9% required dose adjustment, with no differences between the two groups (p = 0.158). Treatment discontinuation was more frequent in patients with R/R patients (74.3% vs 39.6%; RR 1.81; 95% CI: 1.23-2.66; p = 0.002). AE were the most common reason for treatment discontinuation (15.7%). A total of 161 AEs were recorded, with infectious AE being the most frequent category. Respiratory infections were significantly more incident in R/R patients (p = 0.046). Patients with prior exposure to immunochemotherapy had an increased risk of treatment discontinuation (HR = 2.15; 95% CI: 1.18-3.89; p = 0.012).

Conclusions: BTKi showed a manageable safety profile, with infections as the most common toxicity and secondary malignancies occurring at rates comparable to those reported in the literature. Treatment discontinuation was less frequent in the frontline setting, underscoring the influence of clinical context and prior therapies. Despite the limitations of a retrospective, single-centre design, this study provides information applicable to daily practice and highlights the importance of close follow-up to optimize both safety and treatment continuity.

Objectives: New drugs such as faricimab have been developed to treat ophthalmic neovascular diseases. While these drugs increase treatment success, they also increase costs. Repackaging drugs strikes a balance between technical requirements and treatment flexibility. The aim of this study was to evaluate the microbiological stability of repackaged faricimab under controlled conditions in order its already demonstrated chemical, biological, and microbiological stability.

Methods: This was a prospective, controlled experimental study. The contents of four vials of faricimab were repackaged into 16 silicone oil-free syringes with a low dead space volume. A bubble adaptor was used to ensure the maximum efficiency from fractioning. All samples were stored at 2-8 °C. Four of the syringes were cultivated on blood and Sabouraud agar at set time points (9 days, 16 days, 23 days, and 30 days). The endpoint of the study was positive microbiological growth in any of the samples. Negative and positive controls were cultivated alongside the test samples.

Results: None of the 16 samples or the negative controls exhibited microbiological growth at any stage of the culturing process. All positive controls showed microbiological growth.

Conclusions: When repackaged in silicone oil-free syringes, faricimab retains microbiological stability for up to 30 days when it is prepared and stored under controlled conditions.