Hemangiol® in infantile haemangioma: A paediatric post-marketing surveillance drug study

Abstract

Aim: Infantile haemangioma (IH) is the most common benign tumour in children. Since 2014, propranolol has become the first-choice therapy and currently Hemangiol® is the only approved drug for complicated haemangioma. This post-marketing study reported the use of Hemangiol® for IH in paediatric practice. Method and Results: From January 2014 to November 2018, 94 children (median age 4 [0;21] months; 75% female) treated with Hemangiol® for proliferative IH were enrolled in the study. The systematic paediatric cardiology consultation never contraindicated beta-blockers. Two Hemangiol® initiation protocols were used: a conventional ambulatory 3-week titration phase protocol (N=76, 80.9%), and a rapid initiation protocol with a 48-hour dose escalation in conventional hospitalization for severe proliferative IH (N=18, 19.1%). In both protocols, the haemodynamic tolerance was good. The mean maintenance dose of Hemangiol® was 2.7±0.8 mg/kg/day, with a median treatment duration of 7 [1.5;19] months. Adverse events (AEs) have been found in 25 (26,6%) patients including 8 (8.5%) patients with serious AEs (uncontrolled bronchial hyperreactivity, N=5; serious hypoglycaemia, N=3). Some patients had one or more AEs, a total of 24 non-serious AEs was reported in 19 patients (sleep disturbances, N=9; respiratory disorders, N=5; digestive disorders, N=6). No cardiac adverse event was reported. Conclusion: This post-marketing surveillance drug study supports the good tolerance of Hemangiol® in children with IH. A rapid initiation protocol is of interest when treatment is urgent. The pre-therapeutic paediatric cardiology consultation should not be systematic but only indicated on specific patients.

Sleep behavior of infants with infantile hemangioma treated with propranolol—a cohort study

“…Our data show that propranolol exposure mainly affects infants’ nighttime sleep consolidation by reducing Sleep Efficiency and, at trend level, increasing the Number of Nighttime Awakenings , compared to untreated infants at age 6 months. This is clearly in line with previous reports on sleep disturbance in propranolol-treated infants [ 2 , 4 – 7 ] and publications on adult patients reporting increased nighttime awakenings, insomnia, and nightmares while on propranolol and other beta-blockers [ 40 – 43 ]. However, infant 24-hour Total Sleep was not affected by propranolol.…”