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Limitation of liability

Pierre Fabre Pharmaceuticals, Inc. shall not be liable for any direct, indirect, incidental, special, or consequential damages resulting from the use or inability to use this website or from the products, services, and information purchased or obtained through Pierre Fabre Pharmaceuticals, Inc., even if Pierre Fabre Pharmaceuticals, Inc. has been advised of the possibility of such damages.

Miscellaneous

This agreement shall be governed by and construed in accordance with the laws of the State of New Jersey without regard to any choice of law principles that could result in the application of the laws of any other jurisdiction. All actions relating to or in connection with this Agreement are to be venued in the state or federal courts of New Jersey.

Pierre Fabre Pharmaceuticals, Inc. shall not be liable for delays or failure to meet its obligations pursuant to this Agreement due to causes beyond the party’s reasonable control, provided the nonperforming party promptly notifies the other party of the nonperformance and takes all reasonable steps to recommence performance promptly.

If any provision of these terms is held to be invalid or unenforceable, the remainder of the provisions shall remain in full force and effect.

You agree that regardless of any statute or law to the contrary, any claim or cause of action arising out of or related to use of this website or these terms must be filed within one (1) year after such claim or cause of action arose. If you have any questions regarding these terms, please e-mail us at medinfo@pfpharmausa.com.



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