Privacy Policy

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HEMANGEOL.com is owned by Pierre Fabre Pharmaceuticals, Inc. You can access HEMANGEOL.com without disclosing your personal data. Our website does not enable our visitors to communicate with other visitors or to post information to be accessed by others. Our website may include links to other companies’ websites. Since we do not control those websites, we encourage you to review the privacy policies posted on those sites. This website does not publish content that is targeted to children.

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With the exception of information gathered for the technical administration of the website, we do not automatically log personal data nor do we link information automatically logged by other means with personal data about specific individuals. On HEMANGEOL.com, we do not collect personally identifiable information from individuals unless they provide it to us voluntarily and knowingly. This means we do not require you to register or provide information to us in order to view our site. This website does not use session or persistent cookies.

Security

We do not give visitors to our website the option of using a secure transmission method to access the content.
Privacy policy version March 1, 2014. It is subject to change without notice.

Privacy Support

Visitors who wish to contact us concerning our privacy policies may do so at the following address:
medinfo@pfpharmausa.com
Pierre Fabre Pharmaceuticals, Inc.
8 Campus Drive
Parsippany, NJ 07054
1-855-PFPHARM (737-4276)



INDICATION
HEMANGEOLTM oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.

IMPORTANT SAFETY INFORMATION
HEMANGEOLTM is contraindicated in the following conditions:
  • Premature infants with corrected age <5 weeks
  • Infants weighing less than 2 kg
  • Known hypersensitivity to propranolol or any of the excipients
  • Asthma or history of bronchospasm
  • Heart rate <80 beats per minute, greater than first degree heart block, or decompensated heart failure
  • Blood pressure < 50/30 mmHg
  • Pheochromocytoma
HEMANGEOLTM prevents the response of endogenous catecholamines to correct hypoglycemia and masks the adrenergic warning signs of hypoglycemia, particularly tachycardia, palpitations and sweating.

HEMANGEOLTM can cause hypoglycemia in children, especially when they are not feeding regularly or are vomiting; withhold the dose under these conditions. Hypoglycemia may present in the form of seizures, lethargy, or coma. If a child has clinical signs of hypoglycemia, parents should discontinue HEMANGEOLTM and call their health care provider immediately or take the child to the emergency room.

Concomitant treatment with corticosteroids may increase the risks of hypoglycemia.

HEMANGEOLTM may cause or worsen bradycardia or hypotension. Monitor heart rate and blood pressure after treatment initiation or increase in dose. Discontinue treatment if severe (<80 beats per minute) or symptomatic bradycardia or hypotension (systolic blood pressure <50 mmHg) occurs.

HEMANGEOLTM can cause bronchospasm; do not use in patients with asthma or a history of bronchospasm. Interrupt treatment in the event of a lower respiratory tract infection associated with dyspnea and wheezing.

HEMANGEOLTM may worsen circulatory function in patients with congestive heart failure or increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies. Investigate infants with large facial infantile hemangioma for potential arteriopathy associated with PHACE syndrome prior to HEMANGEOLTM therapy.

HEMANGEOLTM will interfere with epinephrine used to treat serious anaphylaxis.

The most frequently reported adverse reactions to HEMANGEOLTM (occurring ≥10% of patients) were sleep disorders, aggravated respiratory tract infections, diarrhea, and vomiting. Adverse reactions led to treatment discontinuation in fewer than 2% of treated patients.

The most common ( >3% more often on HEMANGEOLTM than on placebo) adverse reactions reported in the a total of 424 patients treated with HEMANGEOLTM 1.2 mg/kg/day or 3.4 mg/kg/day were sleep disorder (17.5%; 16.1%), bronchitis (8%; 13.4%), peripheral coldness (8%; 6.7%), agitation (8.5%; 4.5%), diarrhea (4.5%; 6.3%), somnolence (5%; 0.9%), nightmare (2%; 6.3%), irritability (5.5%; 1.3%), decreased appetite (2.5%; 3.6%), and abdominal pain (3.5%; 0.4%), respectively.

Adverse events such as cardiac disorders, urticaria, alopecia, hypogylcemia, and bradycardia occurred in less than 1%.

Safety and effectiveness for infantile hemangioma have not been established in pediatric patients greater than 1 year of age.

Please see Full Prescribing Information and Medication Guide .

Important Safety Information