Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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;
5 WARNINGS AND PRECAUTIONS Cardiopulmonary reactions, including fatalities.
Always have resuscitation equipment and trained personnel readily available ( 5.1 ) Hypersensitivity reactions.
Serious acute hypersensitivity reactions have occurred in patients with no prior exposure to sulfur hexafluoride lipid-containing microsphere products, including patients with prior hypersensitivity reaction(s) to PEG ( 5.2 , 6 ) 5.1 Serious Cardiopulmonary Reactions Serious cardiopulmonary reactions, including fatalities have occurred uncommonly during or shortly following administration of ultrasound contrast agents, including Lumason.
These reactions typically occurred within 30 minutes of administration.
The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias).
Like all medications, Lumason can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: