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A Treatment Option for Infantile Hemangioma Is Here

The First and Only FDA-Approved Treatment for Proliferating Infantile Hemangioma Requiring Systemic Therapy
  • 60% of infantile hemangioma completely or nearly completely resolved by 6 months vs 4% for placebo
  • 88% of infantile hemangioma showed improvement after 5 weeks of treatment.*

*Based on independent-investigator assessment of telangiectasis, color, textural change and distortion of anatomical landmarks or skin contours compared to baseline.

hemangeol baby bottle

The Discovery of Propranolol in the Treatment of Infantile Hemangioma

In 2007, while treating a baby for Infantile Hemangioma with oral steroids, the baby presented a cardiomyopathy (a complication of this treatment). Therefore, the child was treated with propranolol. Dr. Christine Léauté-Labréze and her colleagues discovered that propranolol hydrochloride (the active ingredient in HEMANGEOL) could also control the growth of hemangiomas. It is believed that the drug may have an effect on proliferating infantile hemangiomas through vasoconstriction, inhibition of angiogenesis, and induction of apoptosis.1

This discovery prompted a randomized, controlled clinical trial to investigate the safety and efficacy of propranolol hydrochloride (HEMANGEOL) for infantile hemangioma, with the goal of developing a pediatric formulation and strength that met regulatory guidelines and requirements, including the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA).2,3

1. Fette A. Propranolol in use for treatment of complex infant hemangiomas: literature review regarding current guidelines for preassessment and standards of care before initiation of therapy. Scientific World Journal. 2013:1-9.

2. Drolet BA, Frommelt PC, Chamlin SL, et al. Initiation and use of propranolol for infantile hemangioma: report of a consensus conference. Pediatrics. 2013;131(1):128-140.

3. European Medicines Agency website. European Medicines Agency decision. https://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500141483.pdf. Accessed January 21, 2023

Proven Efficacy

Complete or Nearly Complete Resolution After 6 Months of Therapy

Statistically significant response was shown in patients (5 weeks to 5 months of age with proliferating infantile hemangiomas) treated with HEMANGEOL versus placebo.

In a pivotal Phase II/III clinical trial (n=460), 4 regimens of propranolol hydrochloride were compared: 1.2 or 3.4 mg/ kg/day in twice daily divided doses for 3 or for 6 months as compared to placebo.

Among patients treated with HEMANGEOL 3.4 mg/kg/day for 6 months

  • 60% of infants receiving HEMANGEOL vs. 4% of those in the placebo group
    met the primary endpoint of complete or nearly complete resolution of infantile hemangioma (P<0.0001)
  • 10% of successful patients at week 24 required retreatment of their infantile hemangioma
  • Life-threatening infantile hemangioma, function-threatening infantile hemangioma, and ulcerated infantile hemangioma with pain and lack of response to simple wound care measures were excluded
  • 88% of patients on HEMANGEOL showed improvement of infantile hemangioma after 5 weeks of treatment*

**Based on independent-investigator assessment of telangiectasis, color, textural change and distortion of anatomical landmarks or skin contours compared to baseline.

hemangeol dose chart

In a second open-label clinical study (n=23), target lesions resolved by 3 months in 36% of infants with proliferating infantile hemangioma, including:

  • Function-threatening infantile hemangioma
  • Infantile hemangioma in certain anatomic locations that often leave scars or deformity
  • Large facial infantile hemangioma
  • Smaller infantile hemangioma in exposed areas
  • Severe ulcerated infantile hemangioma
  • Pedunculated infantile hemangioma

Efficacy At a Glance

hemangeol dose chart

Before and After HEMANGEOL Treatment
*individual results may vary

hemangeol side effects

Before and After HEMANGEOL Treatment
*individual results may vary

1. Data on file. Pierre Fabre Pharmaceuticals, Inc., 2014. 2. Leaute-Labreze, Frieden I, Voisard J. Propranolol in infantile hemangiomas: results from an international double-blind, randomized, placebo controlled, multidose, adaptive phase 2/3 study. Presented at: AAD 71st annual meeting March 1-5 2013, Miami, FL.

Safety Profile

The most frequently reported adverse reactions (≥10%) in infants treated with HEMANGEOL were:

  • Sleep disorders
  • Aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever
  • Diarrhea
  • Vomiting

The following adverse events were observed with an incidence of less than 1%:

  • Cardiac disorders
  • Decreased blood glucose
  • Decreased heart rate
  • Urticaria
  • Alopecia

Fewer than 2% of treated patients discontinued treatment due to adverse reactions

hemangeol dose chart

Mechanism of Action Hypothesis

The mechanism of action of HEMANGEOL (propranolol hydrochloride) in infantile hemangioma is not well understood.

The hypothesis is that the drug’s effect on proliferating infantile hemangioma can be attributed to 3 molecular mechanisms, leading to1:

  • A local hemodynamic effect (reduction in blood flow)
  • An anti-angiogenic effect (reduction of growth factors)
  • An apoptosis triggering effect on capillary endothelial cells (increase rate of infantile hemangioma cell death)
hemangeol dose chart
1. Storch CH, Hoeger PH. Propranolol for infantile haemangiomas: insights into the molecular mechanisms of action. Br J Dermatol. 2010;163:269–274.

Important Safety Information for HEMANGEOL
HEMANGEOL can cause serious side effects, including low blood sugar (hypoglycemia), for your child. Please read the important safety information for HEMANGEOL and speak with your doctor before taking HEMANGEOL.

HEMANGEOL Important Safety Information

Important Safety Information for HEMANGEOL

Do not give HEMANGEOL to your child if your child:

  • was born prematurely and has not reached the corrected age of 5 weeks
  • weighs less than 4 ½ pounds
  • is allergic to propranolol or any of the other ingredients in HEMANGEOL
  • has asthma or a history of breathing problems
  • has a heart problem, slow heart rate (less than 80 heart beats per minute), very low blood pressure
  • is at risk for low blood sugar, for example is vomiting or unable to take feedings
  • has high blood pressure caused by a tumor on the adrenal gland, called “pheochromocytoma”


Tell your doctor about all of your child’s medical conditions, all of the medicines your child takes, and all of the medicines that you take if you are breastfeeding your child.

HEMANGEOL can cause serious side effects, including:

Low blood sugar (hypoglycemia), especially if your child is not taking feedings, or is vomiting. HEMANGEOL may make it more difficult to recognize the signs and symptoms of low blood sugar in your child. To help reduce the risk of low blood sugar with HEMANGEOL, give HEMANGEOL during or shortly after feeding your child. Feed your child regularly during treatment. Tell your doctor if your child has a poor appetite. If your child is not taking feedings, due to an illness or vomiting, do not give HEMANGEOL until your child is taking feedings normally again.

If your child has any of the signs or symptoms of low blood sugar listed below during treatment with HEMANGEOL, stop giving your child HEMANGEOL and call your doctor or go to the nearest emergency room right away.

Signs or symptoms of low blood sugar include: pale, blue or purple skin color, sweating, irritability, crying for no apparent reason, irregular or fast heartbeat, poor feeding, low body temperature, unusual sleepiness, seizures, breathing stops for short periods of time, and loss of consciousness

If your child is conscious, give him/her a drink of a liquid containing sugar.

Other serious side effects can include:
  • New or worsening slow heart rate (bradycardia) or low blood pressure (hypotension).
  • Breathing problems or wheezing.
  • Stroke. HEMANGEOL may increase the risk of stroke in certain children who have severe problems with the blood vessels in their brain, particularly if your child has a large hemangioma that affects the face or head.


Call your doctor or go to the nearest hospital emergency room if your child has:

  • pale skin color, slow or uneven heartbeats, arms or legs feel cold, blue or purple skin color, or fainting.
  • breathing problems or wheezing during treatment with HEMANGEOL.


The most common side effects include: sleep problems, worsening respiratory tract infections, diarrhea, and vomiting.

These are not all the possible side effects of HEMANGEOL. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Full Prescribing Information and Medication Guide.