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.
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