The safety profile of Polyoxidonium in daily practice: results from postauthorization safety study in Slovakia.

AIM

This study assessed the safety of Polyoxidonium 6 mg lyophilisate for solution for injection in routine practice with a special focus on signs or symptoms of potential adverse renal effects.

MATERIALS & METHODS: A local, multicenter, prospective, open-label, noninterventional, uncontrolled postauthorization safety study was conducted in 15 healthcare centers in Slovakia. Adult patients who received commercially available Polyoxidonium 6 mg lyophilisate for solution for injection as a part of their routine care were observed for one cycle of treatment, consisting of five or ten injections. For safety assessment, adverse events were monitored with a special focus on signs or symptoms of potential adverse renal effects. At the end of the study, investigators and subjects rated the overall tolerance of Polyoxidonium treatment as well as improvement. Data collection was based on the review of medical records and routine examination of subjects.

RESULTS

In total, 502 subjects were enrolled and 498 (99.2%) subjects completed the study. 19 (3.8%) subjects experienced a total of 34 adverse events. Only one (0.1%) subject experienced eight adverse drug reactions (ADRs): restlessness, fatigue, feeling hot (n = 2), pyrexia (n = 3) and asthenia. There were no renal ADRs or serious ADRs. At the end of the study, both investigators and subjects very positively rated global tolerability and global improvement.

CONCLUSION

Polyoxidonium was well tolerated in the heterogenous population of patients, mostly with chronic recurrent bacterial or viral infections. No renal ADRs were reported in this postauthorization safety study, which was designed with a special focus on identifying potential adverse renal effects.