Propanolol Oral Solution (Hemangeol): A Breakthrough in Treating Infantile Hemangioma

Infantile hemangioma is a common vascular tumor that affects infants and young children. Although many hemangiomas resolve spontaneously, some can cause complications, necessitating medical intervention.¹

Image credit: Ольга Иванова - stock.adobe.com

Hemangeol, a propranolol-based oral solution, has emerged as a groundbreaking treatment for infantile hemangiomas, providing a safe and effective therapeutic option for pediatric patients.² This article explores the significance of Hemangeol in the management of infantile hemangioma, its mechanism of action, safety profile, and its impact on patient outcomes.

Infantile hemangiomas are benign tumors characterized by an overgrowth of blood vessels. They often appear shortly after birth and go through a phase of rapid growth, typically between the ages of 1 and 3 months. After this proliferative phase, most hemangiomas enter a slow involution phase, eventually resolving without intervention. However, some hemangiomas may pose risks, especially when located near vital structures, such as the eyes, nose, or throat, leading to complications like vision impairment, breathing difficulties, or disfigurement.³

Before the emergence of Hemangeol, the treatment of infantile hemangiomas primarily involved surgical procedures, laser therapy, or corticosteroids, each with its limitations and potential adverse effects. Hemangeol, a beta-blocker that contains propranolol, was approved by the FDA in 2014 as the first and only pharmacological treatment for infantile hemangioma.⁴ Its approval marked a significant milestone in pediatric dermatology.

Hemangeol's active ingredient, propranolol, is a non-selective beta-blocker that works by reducing the proliferation of blood vessels in the hemangioma. It achieves this by blocking beta-adrenergic receptors, which control blood vessel dilation and growth.

As a result, Hemangeol slows down the growth of the hemangioma, preventing complications and promoting its gradual involution. It is manufactured as oral solution (4.28 mg/mL propranolol hydrochloride) that may be diluted in a small quantity of milk or fruit juice, given in a baby’s bottle.⁵

It is recommended to initiate treatment at 5 weeks to 5 months of age. The starting dose is 0.15 mL/kg (0.6 mg/kg) twice daily and after 1 week, then increase dose to 0.3 mL/kg (1.1 mg/kg) twice daily. After 2 weeks it is recommended increase to a maintenance dose of 0.4 mL/kg (1.7 mg/kg) twice daily.

Producent is recommending administering doses at least 9 hours apart during or after feeding as well as to readjust dosing for changes in the child’s weight. Because it is a non-selective beta blocker, it is recommended to monitor heart rate and blood pressure for 2 hours after the first dose or increasing dose.⁶

Medication is not recommended to premature infants with corrected age less than 5 months or infants weighting less than 2 kg. Although beta blockers may cause hypoglycemia, it is recommended to administer the drug during or after feeding.

Propranolol should not be used in patients who are not able to feed or who are vomiting because of the hypoglycemia risk. Producent recommends monitoring heart rate and blood pressure for 2 hours after initiation or dose increases.

That medication should not be given to patients with bradycardia (<80 beats per minute), greater than first dree block, decompensated heart failure or if blood pressure is less than 50/30 mmHg, and pheochromocytoma. It may cause bronchospasm, therefore it is recommended to avoid use in patients with asthma or lower respiratory infection. The dedication may increase the risk of stroke in PHACE syndrome. Propranolol as a beta-blocker may interfere with epinephrine used to treat serious anaphylaxis.⁶

One of the key advantages of Hemangeol is its favorable safety profile when administered under medical supervision. It is administered as an oral solution, making it convenient for pediatric patients and caregivers; however, close monitoring of vital signs, including heart rate and blood pressure, is essential during treatment.

The introduction of Hemangeol has had a profound impact on the management of infantile hemangiomas. Its efficacy in reducing the size and complications of hemangiomas has been well-documented in clinical trials and real-world clinical practice. Patients treated with Hemangeol have experienced improved cosmetic outcomes, reduced pain, and a decreased risk of complications associated with untreated or inadequately managed hemangiomas.

Hemangeol represents a significant advancement in the treatment of infantile hemangioma, offering a safe and effective pharmacological option for pediatric patients. Targeting the underlying mechanism of hemangioma growth has revolutionized the approach to managing this common pediatric condition.

However, it is essential that Hemangeol is administered under the guidance of experienced health care professionals who can monitor its effects and ensure the safety and well-being of the young patients. As research and clinical experience continue, Hemangeol's role in the management of infantile hemangioma is likely to expand, further improving the lives of affected children.

References

1. Margileth AM, Museles M. Cutaneous hemangiomas in children. Diagnosis and conservative management. JAMA. 1965 Nov 1. 194(5):523-6.
2. Drolet BA, Frommelt PC, Chamlin SL, Haggstrom A, et al. Initiation and use of propranolol for infantile hemangioma: report of a consensus conference. Pediatrics. 2013 Jan. 131(1):128-40.
3. Darrow DH, Greene AK, Mancini AJ, et al. Diagnosis and management of infantile hemangioma. Pediatrics. 2015;136(4):e1060-1104.
4. Pierre Fabre obtains FDA approval to market HemangeolTM for the treatment of infantile hemangioma Business Wire 2014 Mar 17. http://www.businesswire.com/news/home/20140317005904/en/Pierre-Fabre-Obtains-FDA-Approval-Market-HemangeolTM#.U1GBMdzXlSU. Accessed on September 2, 2023.
5. Hemangiol (propranolol) [product monograph]. Brossard, Quebec, Canada: Pierre-Fabre Dermo-Cosmetique; February 2018.
6. Hemangeol (propranolol) [prescribing information]. Parsippany, NJ: Pierre Fabre Pharmaceuticals, Inc; December 2019.