5PSQ-058 The importance of monitoring adverse drug reactions: data from the treatment of a rare disease

Background and importance Idiopathic pulmonary fibrosis (IPF) is a rare disease characterised by scar tissue formation in the lungs. The prevalence is higher in men (20/100 000) than women (13/100 000). The average age at onset is 66 years. Currently, nintedanib and pirfenidone are used to treat IPF. They have an antifibrotic and anti-inflammatory activity, slowing down the progression of the disease and are subjected to additional monitoring. It is very important to report any suspected adverse drug reaction (ADR) to better understand the efficacy and safety profiles of both of these drugs. Aim and objectives We analysed the ADRs reported in the year 2018 for pirfenidone and nintedanib in our hospital. Material and methods Suspected ADRs reported by patients and sent to the national pharmacovigilance network (RNFV) were analysed. Results Eleven ADRs were recorded for each drug. Considering that the number of patients treated with pirfenidone was 19 and with nintedanib 25, the number of ADRs reported appeared to be quite relevant. Pirfenidone ADR reports were: 5 (45.4%) skin disorders, such as dermatitis, erythema and photosensitivity; 3 gastrointestinal disorders (27.2%), such as diarrhoea, nausea, dysgeusia and inappetence; 2 nervous system (18.2%), with sleepiness and confusion; and in 1 case (9%) there was an increase in levels of aspartate aminotransferase, with a probable onset of hepatic alteration. The reports for nintedanib were 7 (63.6%) for the gastrointestinal system, of which 4 consisted of diarrhoea, and the others asthenia and nausea; and 4 (36.4%) related to toxic hepatitis, of which 1 was reported as serious. The pulmonologists, therefore, reduced the daily dose for 12 patients (54.5%); for 2 patients (9%) they changed therapy from pirfenidone to nintedanib and for the remaining ones they temporarily suspended treatment (36.4%). Conclusion and relevance Initially IPF had been treated with cortisone drugs, azathioprine and cyclophosphamide, while in the past 10 years the development of novel more specific medicines significantly prolonged life expectancy. Nevertheless, it is essential to carry out continuous monitoring of drugs to ensure that patients are treated as effectively and safely as possible. The pharmacist plays a central role in this activity, through direct interaction with patients during dispensing of medicines. References and/or acknowledgements No conflict of interest.