What is Hemangiol - propranolol used for?
Hemangiol is a medicine that contains the active substance propranolol . It is indicated in the treatment of children suffering from a proliferative infantile hemangioma, a benign tumor (abnormal growth of non-tumor tissue) of blood vessels. Hemangiol is used in infants with serious complications, including ulcers accompanied by pain, at risk of scarring and with difficulty breathing, which require systemic therapy (treatment that can have an effect on the whole organism). Treatment with Hemangiol should be started in children aged 5 weeks to 5 months.
How is Hemangiol - propranolol used?
Hemangiol can only be obtained with a prescription. Treatment should be initiated by a physician experienced in the diagnosis, treatment and management of infantile hemangiomas, in a structure suitable for the management of any serious side effects. Hemangiol is available as a solution to be administered by mouth. The recommended starting dose of Hemangiol is 0.5 mg per kilogram of body weight (0.5 mg / kg), taken twice a day (at least 9 hours apart). The dose is progressively increased to reach the maintenance dose of 1.5 mg / kg twice a day. The dose is given to the child during or immediately after a meal, using the oral syringe supplied with the bottle. Treatment with Hemangiol should last for at least six months and the patient should be monitored once a month, particularly to allow the doctor to adjust the dose. For more information, see the package leaflet.
How does Hemangiol - propranolol work?
The active substance in Hemangiol, propranolol, belongs to a group of medicines called beta-blockers, which have been widely used to treat a variety of conditions in adult patients, including heart disease and hypertension. Although the mechanism of action of Hemangiol in the proliferative infantile hemangioma is not precisely known, it is believed that more mechanisms are involved, including the narrowing of blood vessels and therefore the reduction of blood flow to hemangioma, the suppression of the formation of new blood vessels in the tumor mass, the induction of abnormal blood vessel cell death and the suspension of the effect of some proteins (called VEGF and bFGF), which are important for blood vessel growth.
What benefit has Hemangiol - propranolol shown during the studies?
Hemangiol was examined in one main study involving 460 children (aged between 5 weeks and 5 months at the start of therapy), suffering from a proliferative infantile hemangioma that required systemic therapy. The study compared different propranolol doses with placebo (a dummy treatment); the main measure of effectiveness was the total or almost complete disappearance of hemangiomas after 6 months of treatment. Hemangiol, taken at a dose of 3 mg / kg per day (in two separate doses of 1.5 mg / kg) for 6 months, has been shown to be more effective than placebo. In about 60% (61 out of 101) of children treated with the most effective dose of Hemangiol (3 mg / kg / day for 6 months) the hemangiomas disappeared completely or almost completely, a result that was only observed in 4 approximately 2% of children treated with placebo.
What is the risk associated with Hemangiol - propranolol?
The most common side effects of Hemangiol (which may affect more than 1 in 10 children) are sleep disorders, respiratory tract infections such as bronchitis (inflammation of the pulmonary airways), diarrhea and vomiting. Serious side effects seen with Hemangiol include bronchospasm (temporary narrowing of the airways) and low blood pressure. For the full list of all side effects reported with Hemangiol, see the package leaflet. Hemangiol should not be given to: premature babies who have not reached the correct age of 5 weeks (the correct age is the age that a premature baby would have if he was born at term); breastfed babies if the mother is being treated with medicines that should not be taken concurrently with propranolol; children with asthma or with a history of bronchospasm; children with certain cardiovascular diseases, including low blood pressure; children prone to having low blood sugar levels. For the full list of limitations, see the package leaflet.
Why has Hemangiol - propranolol been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hemangiol's benefits are greater than its risks and recommended that it be approved for use in the EU. The committee concluded that Hemangiol is an effective therapy for hemangioma. As for safety, the CHMP considered that the safety profile of the medicine is acceptable; the risks identified are those already known for propranolol and can be adequately managed.
What measures are being taken to ensure the safe and effective use of Hemangiol - propranolol?
A risk management plan has been developed to ensure that Hemangiol is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hemangiol, including the appropriate precautions to be followed by healthcare professionals and patients. The company will provide healthcare professionals who will administer Hemangiol to patients with an information package to inform them of the need to monitor children to detect the occurrence of some undesirable effects and to give indications on the management of these effects. It will also provide instructions on how to properly administer the medicine to avoid the risk of low blood sugar levels. Further information is available in the summary of the risk management plan.
Other information on Hemangiol - propranolol
On 23 April 2014, the European Commission issued a marketing authorization for Hemangiol, valid throughout the European Union. For more information about treatment with Hemangiol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 04-2014.
