Oral Administration by Parents and Caregivers

HEMANGEOLTM (propranolol hydrochloride) oral solution 4.28 mg/mL should be initiated in infants aged 5 weeks to 5 months. It is contraindicated in premature infants with corrected age younger than 5 weeks and in infants weighing less than 2 kg. See more important safety information at right. HEMANGEOL(TM)HEMANGEOLTM is administered through a unique graduated syringe. In order to minimize the risk of hypoglycemia, HEMANGEOLTM should be given to infants during or right after a feeding. If necessary, HEMANGEOLTM may be diluted in a small amount of milk or fruit juice in a baby bottle.

Recommended Dosing

  • Week 1 – starting dose is 0.15 mL/kg (0.6 mg/kg) twice daily
  • Week 2 – increase dose to 0.3 mL/kg (1.1 mg/kg) twice daily
  • Week 3 – increase to a maintenance dose of 0.4 mL/kg (1.7 mg/kg) twice daily
  • Administer twice daily doses at least 9 hours apart during or after feeding
  • Readjust dose for changes in the child’s weight
  • Monitor heart rate and blood pressure for 2 hours after the first dose or increasing dose
  • Duration of treatment: 6 months

HEMANGEOLTM is supplied with a unique graduated oral dosing syringe and syringeadapter as a convenience to parents and caregivers.

HEMANGEOLTM is a pediatric oral solution:

  • Alcohol free, sugar free, and paraben free
  • Strawberry and vanilla flavor


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