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. ClinicalTrials.gov:
NCT 04105517.