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 beat
    • Urticaria
    • Alopecia
  • Fewer than 2% of treated patients discontinued treatment due to adverse reactions

Compassionate Use Program

More than 600 infants received HEMANGEOL in a compassionate use program (CUP). Mean age at treatment initiation was 3.6 months. Mean dose of HEMANGEOL was 2.2 mg/kg/day and mean treatment duration was 7.1 months.

The adverse reactions reported in the CUP were similar to the adverse drug reactions observed during clinical trials but some were more severe.



HEMANGEOL® (propranolol hydrochloride) oral solution is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.

Important Safety Information

CONTRAINDICATIONS

HEMANGEOL® (propranolol hydrochloride) oral solution 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

WARNINGS AND PRECAUTIONS

HEMANGEOL prevents the response of endogenous catecholamines to correct hypoglycemia and masks the adrenergic warning signs of hypoglycemia, particularly tachycardia, palpitations and sweating. HEMANGEOL 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 HEMANGEOL 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.

HEMANGEOL 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.

HEMANGEOL 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.

HEMANGEOL 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 HEMANGEOL therapy.

HEMANGEOL will interfere with epinephrine used to treat serious anaphylaxis.

ADVERSE REACTIONS

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

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