LumaSon
Generic: SULFUR HEXAFLUORIDE
Basic Information
Manufacturer
BRACCO DIAGNOSTICS INC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
7c679424-c3f7-ed02-892f-20ca0d775089
Indications & Usage
1 INDICATIONS AND USAGE Echocardiography Lumason is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
Ultrasonography of the Liver Lumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions.
Ultrasonography of the Urinary Tract Lumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux.
Lumason is an ultrasound contrast agent indicated for use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms ( 1 ) in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients ( 1 ) in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients ( 1 )
Ultrasonography of the Liver Lumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions.
Ultrasonography of the Urinary Tract Lumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux.
Lumason is an ultrasound contrast agent indicated for use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms ( 1 ) in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients ( 1 ) in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients ( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Cardiopulmonary reactions [see Warnings and Precautions ( 5.1 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence ≥ 0.5%) are headache and nausea ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults In completed clinical trials, a total of 6984 adult subjects (128 healthy volunteers and 6856 patients) received Lumason at cumulative doses ranging from 0.2 to 161 mL (mean 9.8 mL).
Lumason was administered mainly as single or multiple injections; however, some subjects received infusion dosing.
The majority (75%) of subjects received Lumason at cumulative doses of 10 mL or less.
There were 64% men and 36% women, with an average age of 59 years (range 17 to 99 years).
A total of 79% subjects were White; 4% were Black; 16% were Asian; <1% were Hispanic; and <1% were in other racial groups or race was not reported.
In the clinical trials, serious adverse reactions were observed in 2 subjects; one who experienced a hypersensitivity-type rash and presyncope and another who experienced anaphylactic shock shortly following Lumason administration.
The most commonly reported adverse reactions among patients (occurring among at least 0.2% of patients) are listed below (Table 1).
Most adverse reactions were mild to moderate in intensity and resolved spontaneously.
*occurring in at least 0.2% of patients Table 1.
Adverse Reactions in Adult Patients* n = 6856 Number (%) of Patients with Adverse Reactions 340 (5%) Headache 65 (1%) Nausea 37 (0.5%) Dysgeusia 29 (0.4%) Injection site pain 23 (0.3%) Feeling Hot 18 (0.3%) Chest discomfort 17 (0.2%) Chest pain 12 (0.2%) Dizziness 11 (0.2%) Injection Site Warmth 11 (0.2%) Pediatric Patients: In completed clinical trials for echocardiography, a total of 12 pediatric patients received Lumason at a dose of 0.03 mL/kg.
No adverse reactions were identified in pediatric patients [see Clinical Studies ( 14.1 )] .
6.2 Postmarketing Experience In the international postmarketing clinical experience and clinical trials, serious adverse reactions have uncommonly been reported following administration of Lumason.
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.
The serious adverse reactions include fatalities, especially in a pattern of symptoms suggestive of anaphylactoid/hypersensitivity reactions.
Other serious reactions included arrhythmias and hypertensive episodes.
These reactions typically occurred within 30 minutes of Lumason administration.
These serious reactions may be increased among patients with pre-existing PEG hypersensitivity and/or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions ( 5.1 , 5.2 )] .
Hypersensitivity Anaphylaxis, with manifestations that may include death, shock, bronchospasm, dyspnea, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema.
To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults In completed clinical trials, a total of 6984 adult subjects (128 healthy volunteers and 6856 patients) received Lumason at cumulative doses ranging from 0.2 to 161 mL (mean 9.8 mL).
Lumason was administered mainly as single or multiple injections; however, some subjects received infusion dosing.
The majority (75%) of subjects received Lumason at cumulative doses of 10 mL or less.
There were 64% men and 36% women, with an average age of 59 years (range 17 to 99 years).
A total of 79% subjects were White; 4% were Black; 16% were Asian; <1% were Hispanic; and <1% were in other racial groups or race was not reported.
In the clinical trials, serious adverse reactions were observed in 2 subjects; one who experienced a hypersensitivity-type rash and presyncope and another who experienced anaphylactic shock shortly following Lumason administration.
The most commonly reported adverse reactions among patients (occurring among at least 0.2% of patients) are listed below (Table 1).
Most adverse reactions were mild to moderate in intensity and resolved spontaneously.
*occurring in at least 0.2% of patients Table 1.
Adverse Reactions in Adult Patients* n = 6856 Number (%) of Patients with Adverse Reactions 340 (5%) Headache 65 (1%) Nausea 37 (0.5%) Dysgeusia 29 (0.4%) Injection site pain 23 (0.3%) Feeling Hot 18 (0.3%) Chest discomfort 17 (0.2%) Chest pain 12 (0.2%) Dizziness 11 (0.2%) Injection Site Warmth 11 (0.2%) Pediatric Patients: In completed clinical trials for echocardiography, a total of 12 pediatric patients received Lumason at a dose of 0.03 mL/kg.
No adverse reactions were identified in pediatric patients [see Clinical Studies ( 14.1 )] .
6.2 Postmarketing Experience In the international postmarketing clinical experience and clinical trials, serious adverse reactions have uncommonly been reported following administration of Lumason.
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.
The serious adverse reactions include fatalities, especially in a pattern of symptoms suggestive of anaphylactoid/hypersensitivity reactions.
Other serious reactions included arrhythmias and hypertensive episodes.
These reactions typically occurred within 30 minutes of Lumason administration.
These serious reactions may be increased among patients with pre-existing PEG hypersensitivity and/or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions ( 5.1 , 5.2 )] .
Hypersensitivity Anaphylaxis, with manifestations that may include death, shock, bronchospasm, dyspnea, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema.