12 April 2014

Hemangeol for Infant Hemangeoma

Propranolol hydrochloride with brand name Hemangeol is a pediatric oral solution which was approved by US-FDA in March 2014. Hemangeol is the first and only approved treatment for “proliferating infantile hemangioma” that requires systemic therapy.

Propranolol has long been known and used in the treatment and prevention of cardiac arrhythmias, but its use in infants with infantile hemangioma had never been properly studied and there was no pharmaceutical form approved for pediatric use. In 2009, Pierre Fabre Dermatologic undertook the pharmaceutical and clinical development of Propranolol for infants suffering from infantile hemangioma, with demonstrated clinical safety and efficacy.

Infantile hemangioma is also commonly referred to as strawberry hemangioma/strawberry birthmark or simply hemangioma. Theyaregrowths of microscopic blood vessels and are usually harmless and is categorised asnon-cancerous condition affecting cutaneous blood vessels. It can be also referred to as proliferative hemangioma, because it is caused by proliferating endothelial cells, the cells that line the blood vessels.These lesions usually develop shortly after birth andresemble “blood blisters” that will pop and bleed if disturbed but hemangiomas are actually solid in nature anddoes not rupture or bleed. The lesions look to be painful but they are not actuallypainful.Majority of the lesions, that is around 80% of infantile hemangiomas generallyappear on the head and neck area. They grow to 80% of maximum size in the first three months and most stop growing at about 5 months. However, they may keep growing for up to 18 months. 

Infantile hemangiomas are classified as superficial, deep or mixed lesions. Theymight be localized, that is, confined to a small area orcould be segmental involving the central or peripheral nervous system.Segmental hemangiomas are more serious than localizedhemangiomas, and there are three types in this: The first type is superficial infantile hemangiomas which are also called capillary haemangioma or haemangioma simplex. The blood vessels in uppermost layers of the skin are dilated in this type of hemangioma.The deep infantile hemangiomas arealso known as cavernous hemangiomas. These are more deeply rooted in the dermis and subcutis. They appear as a bluish soft to firm swelling.The third category is the mixed hemangiomaswhich are combination of both types of haemangiomas.

The vast majority of these cases do not require any medical or surgical intervention. Medical care of clinically significant hemangiomas has been limited to a few medications, including glucocorticosteroids (topical, intralesional, and oral), interferon alfa, and rarely, vincristine and topical imiquimod.

Hemangeol was specially formulated for the use in pediatric population following the guidelines of health regulatory agencies.The FDA approval of Hemangeol was based on a randomized, double blind placebo controlled, multi-dose and multi-center adaptive phase II/III trial, which compared four Propranolol treatment regimens (1 or 3 mg/kg/day for 3 or 6 months) versus placebo. The study was conducted in infants5 weeks to 5 months old who were suffering with a proliferative infantile hemangioma requiring systemic treatment. The treatment protocol of 3 mg/kg/day dose for the duration of 6 months had a 60.4% success rate versus 3.6% in the placebo group (p< 0.0001) reaching the primary endpoint: complete or nearly-complete resolution of the target hemangioma. 11.4% of patients needed to be retreated after stopping the treatment.

Hemangeol is contraindicated in premature infants with age less than 5 weeks or in infants weighing less than 2 kg.It is also contraindicated to infants suffering from asthma or history of bronchospasm, heart rate less than80 beats per minute, greater than first degree heart block, or heart failure; blood pressure less than 50/30 mmHg; or subjects with neuroendocranial tumor called as pheochromocytoma.

The reported adverse reactions in infants treated with Hemangeol were sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough, fever, diarrhoea, and vomiting.Although some cases of hemangioma do not need treatment and only needs watchful observation,some proliferating infantile hemangioma obviously require proper treatment regimen to control the progression of the disease.

Hemangeol is a boon for infants with hemangeoma as the beta-blocker Propranolol has been shown to clear infant hemangioma after 6 months of treatment, according to preliminary findings from a clinical trial. Hemangeol is the first medical treatment that was approved by US-FDA for the treatment of infantile hemangioma.

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