Hemangeol
(Propranolol Hydrochloride)Dosage & Administration
Initiate treatment at ages 5 weeks to 5 months.
The recommended starting dose of HEMANGEOL is 0.15 mL/kg (0.6 mg/kg) (see Table 1) twice daily, taken at least 9 hours apart. After 1 week, increase the daily dose to 0.3 mL/kg (1.1 mg/kg) twice daily. After 2 weeks of treatment, increase the dose to 0.4 mL/kg (1.7 mg/kg) twice daily and maintain this for 6 months. Readjust the dose periodically as the child’s weight increases.
To reduce the risk of hypoglycemia, administer HEMANGEOL orally during or right after a feeding. Skip the dose if the child is not eating or is vomiting
Warnings and Precautions (5.1)]
Monitor heart rate and blood pressure for 2 hours after HEMANGEOL initiation or dose increases
Warnings and Precautions (5.2)].
If hemangiomas recur, treatment may be re-initiated
A randomized, double-blind study in 460 infants, aged 35 days to 5 months at inclusion, with proliferating infantile hemangiomas (IH) requiring systemic therapy (excluding life-threatening IH, function-threatening IH, and ulcerated IH with pain and lack of response to simple wound care measures) compared four regimens of HEMANGEOL (1.2 or 3.4 mg/kg/day in twice daily divided doses for 3 or 6 months; N=99-103 per group) to placebo (N=55). Clinical efficacy was evaluated by counting complete or nearly complete resolution of the target hemangioma, which was evaluated by blinded centralized independent assessments of photographs at Week 24 compared to baseline.
Demographic patient characteristics and hemangioma characteristics were similar among the five regimens. For the whole population, 29% were male, 37% were in the lower age group (35-90 days), and 72% were Caucasian. Overall, 70% had a target hemangioma on the head, most commonly cheek (13%) and forehead (11%).
The main reason for treatment discontinuation was the treatment inefficacy, which happened in 58% of patients randomized to placebo, 25-30% of patients randomized to HEMANGEOL for 3 months (mainly after the switch to placebo), and 7-9% of patients randomized to HEMANGEOL for 6 months.
Overall, 2 out of 55 patients (4%) in the placebo arm and 61 out of 101 patients (60%) on HEMANGEOL 3.4 mg/kg/day for 6 months had complete or nearly complete resolution of their hemangioma at Week 24 (p <0.0001).
There were no significant differences in response by age (35-90 days / 91-150 days), sex, or hemangioma site. There were too few non-Caucasians to assess differences in effects by race.
Of patients on HEMANGEOL 3.4 mg/kg/day for 6 months who were considered successes, 10% required retreatment for recurrence of hemangiomas.
A second uncontrolled study in 23 patients with proliferating IH included function-threatening IH, IH in certain anatomic locations that often leave permanent scars or deformity, large facial IH, smaller IH in exposed areas, severe ulcerated IH, pedunculated IH. Target lesions resolved in 36% of patients by 3 months.
HEMANGEOL is supplied with an oral dosing syringe for administration. Administration directly into the child’s mouth is recommended. Nevertheless, if necessary, the product may be diluted in a small quantity of milk or fruit juice, given in a baby’s bottle.
| Week 1 | Week 2 | Week 3 (maintenance) | |
Weight (kg) | Volume administered | Volume administered | Volume administered |
twice a day | twice a day | twice a day | |
2 to <2.5 | 0.3 mL | 0.6 mL | 0.8 mL |
2.5 to <3 | 0.4 mL | 0.8 mL | 1 mL |
3 to <3.5 | 0.5 mL | 0.9 mL | 1.2 mL |
3.5 to <4 | 0.5 mL | 1.1 mL | 1.4 mL |
4 to <4.5 | 0.6 mL | 1.2 mL | 1.6 mL |
4.5 to <5 | 0.7 mL | 1.4 mL | 1.8 mL |
5 to <5.5 | 0.8 mL | 1.5 mL | 2 mL |
5.5 to <6 | 0.8 mL | 1.7 mL | 2.2 mL |
6 to <6.5 | 0.9 mL | 1.8 mL | 2.4 mL |
6.5 to <7 | 1 mL | 2 mL | 2.6 mL |
7 to <7.5 | 1.1 mL | 2.1 mL | 2.8 mL |
7.5 to <8 | 1.1 mL | 2.3 mL | 3 mL |
8 to <8.5 | 1.2 mL | 2.4 mL | 3.2 mL |
8.5 to <9 | 1.3 mL | 2.6 mL | 3.4 mL |
9 to <9.5 | 1.4 mL | 2.7 mL | 3.6 mL |
9.5 to <10 | 1.4 mL | 2.9 mL | 3.8 mL |
10 to <10.5 | 1.5 mL | 3 mL | 4 mL |
10.5 to <11 | 1.6 mL | 3.2 mL | 4.2 mL |
11 to <11.5 | 1.7 mL | 3.3 mL | 4.4 mL |
11.5 to <12 | 1.7 mL | 3.5 mL | 4.6 mL |
| 12 to <12.5 | 1.8 mL | 3.6 mL | 4.8 mL |
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Hemangeol Prescribing Information
HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.
Initiate treatment at ages 5 weeks to 5 months.
The recommended starting dose of HEMANGEOL is 0.15 mL/kg (0.6 mg/kg) (see Table 1) twice daily, taken at least 9 hours apart. After 1 week, increase the daily dose to 0.3 mL/kg (1.1 mg/kg) twice daily. After 2 weeks of treatment, increase the dose to 0.4 mL/kg (1.7 mg/kg) twice daily and maintain this for 6 months. Readjust the dose periodically as the child’s weight increases.
To reduce the risk of hypoglycemia, administer HEMANGEOL orally during or right after a feeding. Skip the dose if the child is not eating or is vomiting
Warnings and Precautions (5.1)]
Monitor heart rate and blood pressure for 2 hours after HEMANGEOL initiation or dose increases
Warnings and Precautions (5.2)].
If hemangiomas recur, treatment may be re-initiated
A randomized, double-blind study in 460 infants, aged 35 days to 5 months at inclusion, with proliferating infantile hemangiomas (IH) requiring systemic therapy (excluding life-threatening IH, function-threatening IH, and ulcerated IH with pain and lack of response to simple wound care measures) compared four regimens of HEMANGEOL (1.2 or 3.4 mg/kg/day in twice daily divided doses for 3 or 6 months; N=99-103 per group) to placebo (N=55). Clinical efficacy was evaluated by counting complete or nearly complete resolution of the target hemangioma, which was evaluated by blinded centralized independent assessments of photographs at Week 24 compared to baseline.
Demographic patient characteristics and hemangioma characteristics were similar among the five regimens. For the whole population, 29% were male, 37% were in the lower age group (35-90 days), and 72% were Caucasian. Overall, 70% had a target hemangioma on the head, most commonly cheek (13%) and forehead (11%).
The main reason for treatment discontinuation was the treatment inefficacy, which happened in 58% of patients randomized to placebo, 25-30% of patients randomized to HEMANGEOL for 3 months (mainly after the switch to placebo), and 7-9% of patients randomized to HEMANGEOL for 6 months.
Overall, 2 out of 55 patients (4%) in the placebo arm and 61 out of 101 patients (60%) on HEMANGEOL 3.4 mg/kg/day for 6 months had complete or nearly complete resolution of their hemangioma at Week 24 (p <0.0001).
There were no significant differences in response by age (35-90 days / 91-150 days), sex, or hemangioma site. There were too few non-Caucasians to assess differences in effects by race.
Of patients on HEMANGEOL 3.4 mg/kg/day for 6 months who were considered successes, 10% required retreatment for recurrence of hemangiomas.
A second uncontrolled study in 23 patients with proliferating IH included function-threatening IH, IH in certain anatomic locations that often leave permanent scars or deformity, large facial IH, smaller IH in exposed areas, severe ulcerated IH, pedunculated IH. Target lesions resolved in 36% of patients by 3 months.
HEMANGEOL is supplied with an oral dosing syringe for administration. Administration directly into the child’s mouth is recommended. Nevertheless, if necessary, the product may be diluted in a small quantity of milk or fruit juice, given in a baby’s bottle.
| Week 1 | Week 2 | Week 3 (maintenance) | |
Weight (kg) | Volume administered | Volume administered | Volume administered |
twice a day | twice a day | twice a day | |
2 to <2.5 | 0.3 mL | 0.6 mL | 0.8 mL |
2.5 to <3 | 0.4 mL | 0.8 mL | 1 mL |
3 to <3.5 | 0.5 mL | 0.9 mL | 1.2 mL |
3.5 to <4 | 0.5 mL | 1.1 mL | 1.4 mL |
4 to <4.5 | 0.6 mL | 1.2 mL | 1.6 mL |
4.5 to <5 | 0.7 mL | 1.4 mL | 1.8 mL |
5 to <5.5 | 0.8 mL | 1.5 mL | 2 mL |
5.5 to <6 | 0.8 mL | 1.7 mL | 2.2 mL |
6 to <6.5 | 0.9 mL | 1.8 mL | 2.4 mL |
6.5 to <7 | 1 mL | 2 mL | 2.6 mL |
7 to <7.5 | 1.1 mL | 2.1 mL | 2.8 mL |
7.5 to <8 | 1.1 mL | 2.3 mL | 3 mL |
8 to <8.5 | 1.2 mL | 2.4 mL | 3.2 mL |
8.5 to <9 | 1.3 mL | 2.6 mL | 3.4 mL |
9 to <9.5 | 1.4 mL | 2.7 mL | 3.6 mL |
9.5 to <10 | 1.4 mL | 2.9 mL | 3.8 mL |
10 to <10.5 | 1.5 mL | 3 mL | 4 mL |
10.5 to <11 | 1.6 mL | 3.2 mL | 4.2 mL |
11 to <11.5 | 1.7 mL | 3.3 mL | 4.4 mL |
11.5 to <12 | 1.7 mL | 3.5 mL | 4.6 mL |
| 12 to <12.5 | 1.8 mL | 3.6 mL | 4.8 mL |
Oral solution: 4.28 mg/mL propranolol hydrochloride.
Alcohol-, paraben- and sugar-free.
Of 460 infants with proliferating infantile hemangioma requiring systemic therapy who were treated with HEMANGEOL starting at 5 weeks to 5 months of age, 60% had complete or nearly complete resolution of their hemangioma at Week 24
A randomized, double-blind study in 460 infants, aged 35 days to 5 months at inclusion, with proliferating infantile hemangiomas (IH) requiring systemic therapy (excluding life-threatening IH, function-threatening IH, and ulcerated IH with pain and lack of response to simple wound care measures) compared four regimens of HEMANGEOL (1.2 or 3.4 mg/kg/day in twice daily divided doses for 3 or 6 months; N=99-103 per group) to placebo (N=55). Clinical efficacy was evaluated by counting complete or nearly complete resolution of the target hemangioma, which was evaluated by blinded centralized independent assessments of photographs at Week 24 compared to baseline.
Demographic patient characteristics and hemangioma characteristics were similar among the five regimens. For the whole population, 29% were male, 37% were in the lower age group (35-90 days), and 72% were Caucasian. Overall, 70% had a target hemangioma on the head, most commonly cheek (13%) and forehead (11%).
The main reason for treatment discontinuation was the treatment inefficacy, which happened in 58% of patients randomized to placebo, 25-30% of patients randomized to HEMANGEOL for 3 months (mainly after the switch to placebo), and 7-9% of patients randomized to HEMANGEOL for 6 months.
Overall, 2 out of 55 patients (4%) in the placebo arm and 61 out of 101 patients (60%) on HEMANGEOL 3.4 mg/kg/day for 6 months had complete or nearly complete resolution of their hemangioma at Week 24 (p <0.0001).
There were no significant differences in response by age (35-90 days / 91-150 days), sex, or hemangioma site. There were too few non-Caucasians to assess differences in effects by race.
Of patients on HEMANGEOL 3.4 mg/kg/day for 6 months who were considered successes, 10% required retreatment for recurrence of hemangiomas.
A second uncontrolled study in 23 patients with proliferating IH included function-threatening IH, IH in certain anatomic locations that often leave permanent scars or deformity, large facial IH, smaller IH in exposed areas, severe ulcerated IH, pedunculated IH. Target lesions resolved in 36% of patients by 3 months.
Safety and effectiveness for infantile hemangioma have not been established in pediatric patients greater than 1 year of age.
HEMANGEOL 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 [see]11 DESCRIPTION
HEMANGEOL is an oral solution of propranolol that is alcohol free, paraben free and sugar free. Each mL of HEMANGEOL contains 4.28 mg of propranolol hydrochloride, USP equivalent to 3.75 mg of propranolol.
Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (2RS)1-[(1-methylethyl)amino]-3-(naphthalene-1-yloxy)-propan-2-ol hydrochloride. Its structural formula is shown in Figure 1:
Figure 1. Propranolol HCl StructureMolecular formula: C16H21NO2-HCl
Propranolol hydrochloride is a stable, white, crystalline solid with a molecular weight of 295.8. It is readily soluble in water and ethanol.
HEMANGEOL contains the following inactive ingredients: strawberry/vanilla flavorings, hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, and water.
Figure 1. Propranolol HCl structure - 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
Hypoglycemia: Administer during or after feeding. Do not use in patients who are not able to feed
or are vomiting (
HEMANGEOL 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[see Description (11)]
- 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
- Premature infants with corrected age <5 weeks
- Infants weighing less than 2 kg
- Known hypersensitivity to propranolol or excipients
- Asthma or history of bronchospasm
- Bradycardia (<80 beats per minute), greater than first degree heart block, decompensated heart failure
- Blood pressure <50/30 mmHg
- Pheochromocytoma
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 at any time during treatment. Risk is increased during a fasting period (e.g., poor oral food intake, infection, vomiting) or when glucose demands are increased (e.g., cold, stress, infections). Withhold the dose under these conditions. Hypoglycemia may present in
the form of seizures, lethargy, or coma. Discontinue HEMANGEOL if hypoglycemia develops and treat appropriately Concomitant treatment with corticosteroids may increase the risk of hypoglycemia [ see Drug Interactions (7) ].
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Hypoglycemia and related events, like hypoglycemic seizure[see Warnings and Precautions (5.1)].
- Bronchospasm[see Warnings and Precautions (5.3)].
The most common adverse reactions to HEMANGEOL (occurring ≥ 10% of patients) were sleep disorders, aggravated respiratory tract infections, diarrhea, and vomiting.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical
trials of a drug may not reflect the rates observed in clinical practice.
In clinical trials for proliferating infantile hemangioma, 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, and vomiting. Adverse reactions led to treatment discontinuation in fewer than 2% of treated patients.
Overall, 479 patients in the pooled safety population were exposed to study drug in the clinical study program (456 in placebo-controlled trials). A total of 424 patients were treated with HEMANGEOL at doses 1.2 mg/kg/day or 3.4 mg/kg/day for 3 or 6 months. Of these, 63% of patients were aged 91-150 days and 37% were aged 35-90 days at randomization.
The following table lists according to the dosage the most common adverse reactions (treatment-emergent adverse events with an incidence at least 3% greater on one of the two doses than on placebo).
Reaction | Placebo N=236 | HEMANGEOL 1.2 mg/kg/day N=200 | HEMANGEOL 3.4 mg/kg/day N=224 |
Sleep disorder | 5.9% | 17.5% | 16.1% |
Bronchitis | 4.7 | 8.0 | 13.4 |
Peripheral coldness | 0.4 | 8.0 | 6.7 |
Agitation | 2.1 | 8.5 | 4.5 |
Diarrhea | 1.3 | 4.5 | 6.3 |
Somnolence | 0.4 | 5.0 | 0.9 |
Nightmare | 1.7 | 2.0 | 6.3 |
Irritability | 1.3 | 5.5 | 1.3 |
Decreased appetite | 0.4 | 2.5 | 3.6 |
Abdominal pain | 0.4 | 3.5 | 0.4 |
The following adverse events have been observed during clinical studies, with an incidence of less than 1%:
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 ADRs observed during clinical trials but some were more severe.
The following adverse reactions have been identified during post-approval use of propranolol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These adverse reactions are as follows:
HEMANGEOL is an oral solution of propranolol that is alcohol free, paraben free and sugar free. Each mL of HEMANGEOL contains 4.28 mg of propranolol hydrochloride, USP equivalent to 3.75 mg of propranolol.
Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (2RS)1-[(1-methylethyl)amino]-3-(naphthalene-1-yloxy)-propan-2-ol hydrochloride. Its structural formula is shown in Figure 1:
Molecular formula: C16H21NO2-HCl
Propranolol hydrochloride is a stable, white, crystalline solid with a molecular weight of 295.8. It is readily soluble in water and ethanol.
HEMANGEOL contains the following inactive ingredients: strawberry/vanilla flavorings, hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, and water.
Read these Instructions for Use before giving a dose of HEMANGEOL to your child for the first time and each time you get a refill. There may be new information. Your doctor or pharmacist should show you how to correctly measure and give a dose of HEMANGEOL to your child before you give it for the first time.
- To reduce the risk of your child getting low blood sugar (hypoglycemia), you must give HEMANGEOL either during a feeding or right away after a feeding.
- Do not give a dose of HEMANGEOL if your child is vomiting, is not taking feedings, or is showing signs or symptoms of low blood sugar.
When you get HEMANGEOL from your doctor or pharmacist, you will receive a box that contains the supplies needed to give HEMANGEOL to your child, including:
- One glass bottle of HEMANGEOL
- One 5 mL oral dosing syringe (inside a plastic bag) that is marked to help you correctly measure a dose of HEMANGEOL (See Figure A). If the carton does not contain the oral dosing syringe, ask your pharmacist to give you an oral dosing syringe that can be used to measure HEMANGEOL.
- Write down on the box the date when you first open the bottle.
- Do not remove the syringe adapter. If the syringe adapter is missing talk to your pharmacist.
- Keep your child in an upright position for a few minutes right after giving a dose of HEMANGEOL.
- If needed, you can dilute the dose of HEMANGEOL in a small amount of milk or fruit juice and give it to your child in a baby’s bottle. If your child spits up a dose or if you are not sure your child got all of the medicine, do not give another dose. Wait until the next scheduled dose.
- Do not take apart the oral dosing syringe.
- Do not use any soap or alcohol based product to clean. Wipe the outside dry.
- Do not put the oral dosing syringe through a sterilizer or dishwasher.
- When not in use, keep the bottle of HEMANGEOL and the oral dosing syringe in the box it comes in.
- Store HEMANGEOL at room temperature, between 68oF to 77oF (20oC to 25oC). Do not freeze.
- Safely throw away any opened bottle of HEMANGEOL after 2 months, even if there is medicine left in the bottle.
Manufactured for:
Pierre Fabre Pharmaceuticals, Inc.
Parsippany, NJ 07054
• Bradycardia and hypotension (
HEMANGEOL 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[see Description (11)]
- 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
- Premature infants with corrected age <5 weeks
- Infants weighing less than 2 kg
- Known hypersensitivity to propranolol or excipients
- Asthma or history of bronchospasm
- Bradycardia (<80 beats per minute), greater than first degree heart block, decompensated heart failure
- Blood pressure <50/30 mmHg
- Pheochromocytoma
HEMANGEOL may cause or worsen bradycardia or hypotension. In the studies of HEMANGEOL for infantile hemangioma the mean decrease in heart rate was about 7 bpm with little effect on blood pressure. 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.
Read these Instructions for Use before giving a dose of HEMANGEOL to your child for the first time and each time you get a refill. There may be new information. Your doctor or pharmacist should show you how to correctly measure and give a dose of HEMANGEOL to your child before you give it for the first time.
- To reduce the risk of your child getting low blood sugar (hypoglycemia), you must give HEMANGEOL either during a feeding or right away after a feeding.
- Do not give a dose of HEMANGEOL if your child is vomiting, is not taking feedings, or is showing signs or symptoms of low blood sugar.
When you get HEMANGEOL from your doctor or pharmacist, you will receive a box that contains the supplies needed to give HEMANGEOL to your child, including:
- One glass bottle of HEMANGEOL
- One 5 mL oral dosing syringe (inside a plastic bag) that is marked to help you correctly measure a dose of HEMANGEOL (See Figure A). If the carton does not contain the oral dosing syringe, ask your pharmacist to give you an oral dosing syringe that can be used to measure HEMANGEOL.
- Write down on the box the date when you first open the bottle.
- Do not remove the syringe adapter. If the syringe adapter is missing talk to your pharmacist.
- Keep your child in an upright position for a few minutes right after giving a dose of HEMANGEOL.
- If needed, you can dilute the dose of HEMANGEOL in a small amount of milk or fruit juice and give it to your child in a baby’s bottle. If your child spits up a dose or if you are not sure your child got all of the medicine, do not give another dose. Wait until the next scheduled dose.
- Do not take apart the oral dosing syringe.
- Do not use any soap or alcohol based product to clean. Wipe the outside dry.
- Do not put the oral dosing syringe through a sterilizer or dishwasher.
- When not in use, keep the bottle of HEMANGEOL and the oral dosing syringe in the box it comes in.
- Store HEMANGEOL at room temperature, between 68oF to 77oF (20oC to 25oC). Do not freeze.
- Safely throw away any opened bottle of HEMANGEOL after 2 months, even if there is medicine left in the bottle.
Manufactured for:
Pierre Fabre Pharmaceuticals, Inc.
Parsippany, NJ 07054
• Bronchospasm: Avoid use in patients with asthma or lower respiratory infection (
HEMANGEOL 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[see Description (11)]
- 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
- Premature infants with corrected age <5 weeks
- Infants weighing less than 2 kg
- Known hypersensitivity to propranolol or excipients
- Asthma or history of bronchospasm
- Bradycardia (<80 beats per minute), greater than first degree heart block, decompensated heart failure
- Blood pressure <50/30 mmHg
- Pheochromocytoma
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.
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Hypoglycemia and related events, like hypoglycemic seizure[see Warnings and Precautions (5.1)].
- Bronchospasm[see Warnings and Precautions (5.3)].
The most common adverse reactions to HEMANGEOL (occurring ≥ 10% of patients) were sleep disorders, aggravated respiratory tract infections, diarrhea, and vomiting.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical
trials of a drug may not reflect the rates observed in clinical practice.
In clinical trials for proliferating infantile hemangioma, 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, and vomiting. Adverse reactions led to treatment discontinuation in fewer than 2% of treated patients.
Overall, 479 patients in the pooled safety population were exposed to study drug in the clinical study program (456 in placebo-controlled trials). A total of 424 patients were treated with HEMANGEOL at doses 1.2 mg/kg/day or 3.4 mg/kg/day for 3 or 6 months. Of these, 63% of patients were aged 91-150 days and 37% were aged 35-90 days at randomization.
The following table lists according to the dosage the most common adverse reactions (treatment-emergent adverse events with an incidence at least 3% greater on one of the two doses than on placebo).
Reaction | Placebo N=236 | HEMANGEOL 1.2 mg/kg/day N=200 | HEMANGEOL 3.4 mg/kg/day N=224 |
Sleep disorder | 5.9% | 17.5% | 16.1% |
Bronchitis | 4.7 | 8.0 | 13.4 |
Peripheral coldness | 0.4 | 8.0 | 6.7 |
Agitation | 2.1 | 8.5 | 4.5 |
Diarrhea | 1.3 | 4.5 | 6.3 |
Somnolence | 0.4 | 5.0 | 0.9 |
Nightmare | 1.7 | 2.0 | 6.3 |
Irritability | 1.3 | 5.5 | 1.3 |
Decreased appetite | 0.4 | 2.5 | 3.6 |
Abdominal pain | 0.4 | 3.5 | 0.4 |
The following adverse events have been observed during clinical studies, with an incidence of less than 1%:
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 ADRs observed during clinical trials but some were more severe.
The following adverse reactions have been identified during post-approval use of propranolol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These adverse reactions are as follows:
HEMANGEOL is an oral solution of propranolol that is alcohol free, paraben free and sugar free. Each mL of HEMANGEOL contains 4.28 mg of propranolol hydrochloride, USP equivalent to 3.75 mg of propranolol.
Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (2RS)1-[(1-methylethyl)amino]-3-(naphthalene-1-yloxy)-propan-2-ol hydrochloride. Its structural formula is shown in Figure 1:
Molecular formula: C16H21NO2-HCl
Propranolol hydrochloride is a stable, white, crystalline solid with a molecular weight of 295.8. It is readily soluble in water and ethanol.
HEMANGEOL contains the following inactive ingredients: strawberry/vanilla flavorings, hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, and water.
Read these Instructions for Use before giving a dose of HEMANGEOL to your child for the first time and each time you get a refill. There may be new information. Your doctor or pharmacist should show you how to correctly measure and give a dose of HEMANGEOL to your child before you give it for the first time.
- To reduce the risk of your child getting low blood sugar (hypoglycemia), you must give HEMANGEOL either during a feeding or right away after a feeding.
- Do not give a dose of HEMANGEOL if your child is vomiting, is not taking feedings, or is showing signs or symptoms of low blood sugar.
When you get HEMANGEOL from your doctor or pharmacist, you will receive a box that contains the supplies needed to give HEMANGEOL to your child, including:
- One glass bottle of HEMANGEOL
- One 5 mL oral dosing syringe (inside a plastic bag) that is marked to help you correctly measure a dose of HEMANGEOL (See Figure A). If the carton does not contain the oral dosing syringe, ask your pharmacist to give you an oral dosing syringe that can be used to measure HEMANGEOL.
- Write down on the box the date when you first open the bottle.
- Do not remove the syringe adapter. If the syringe adapter is missing talk to your pharmacist.
- Keep your child in an upright position for a few minutes right after giving a dose of HEMANGEOL.
- If needed, you can dilute the dose of HEMANGEOL in a small amount of milk or fruit juice and give it to your child in a baby’s bottle. If your child spits up a dose or if you are not sure your child got all of the medicine, do not give another dose. Wait until the next scheduled dose.
- Do not take apart the oral dosing syringe.
- Do not use any soap or alcohol based product to clean. Wipe the outside dry.
- Do not put the oral dosing syringe through a sterilizer or dishwasher.
- When not in use, keep the bottle of HEMANGEOL and the oral dosing syringe in the box it comes in.
- Store HEMANGEOL at room temperature, between 68oF to 77oF (20oC to 25oC). Do not freeze.
- Safely throw away any opened bottle of HEMANGEOL after 2 months, even if there is medicine left in the bottle.
Manufactured for:
Pierre Fabre Pharmaceuticals, Inc.
Parsippany, NJ 07054
• Increased risk of stroke in PHACE syndrome (
By dropping blood pressure, HEMANGEOL may 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.