Propandiol in infantile haemangioma

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The European Commission granted a marketing authorisation valid throughout the European Union for Hemangiol on 23 April 2014. Hemangiol is a medicine that contains the active substance propranolol and It is used to treat children with proliferating infantile haemangioma (benign tumours of blood vessels. Hemangiol is used in infants with serious complications, such as painful ulcers, scarring and breathing difficulties, who require systemic therapy (treatment which can have an effect on the whole body). The active substance propranolol is a beta-blocker, a class of medicines that have been widely used to treat diseases of the heart and high blood pressure in adult. It is not exactly known how it works in proliferative infantile haemangioma, it is thought to do so by several mechanisms including narrowing the blood vessels and so decreasing blood supply to the haemangioma, blocking the formation of new blood vessels in the growth, triggering cell death of the abnormal blood vessel cells and blocking the effect of certain proteins (called VEGF and bFGF), which are important for the growth of blood vessels. Hemangiol was investigated in one main study involving 460 children aged from five weeks to five months at the start of treatment and who had proliferative infantile haemangioma that required systemic therapy. Hemangiol at a dose of 3 mg/kg per day given for 6 months was shown to be more effective than placebo. In around 60% (61 out of 101) of children treated with the most effective dose of Hemangiol (3 mg/kg/day for 6 months), haemangiomas disappeared completely or almost completely compared with around 4% (2 out of 55) in children who received placebo. The most common side effects are sleep disorders, respiratory tract infections such as bronchitis, diarrhoea and vomiting. Serious side effects observed include bronchospasm and low blood pressure. Hemangiol is available as a solution to be taken by mouth. The recommended starting dose of Hemangiol is 0.5 mg per kilogram bodyweight (0.5 mg/kg), twice a day (at least 9 hours apart). The dose is progressively increased to a maintenance dose of 1.5 mg/kg twice a day.

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