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 adverse reactions are discussed in greater detail in other sections of the label: Nephrogenic systemic fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Warnings and Precautions (5.3) ] The most commonly reported adverse reactions are nausea (1.3%) and headache (1.2%).
(6) 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 clinical trials with MultiHance, a total of 4967 adult subjects (137 healthy volunteers and 4830 patients) received MultiHance at doses ranging from 0.005 to 0.4 mmol/kg.
There were 2838 (57%) men and 2129 (43%) women with a mean age of 56.5 years (range 18 to 93 years).
A total of 4403 (89%) subjects were Caucasian, 134 (3%) Black, 275 (6%) Asian, 40 (1%) Hispanic, 70 (1%) in other racial groups, and for 45 (1%) subjects, race was not reported.
The most commonly reported adverse reactions in adult subjects who received MultiHance were nausea (1.3%) and headache (1.2%).
Most adverse reactions were mild to moderate in intensity.
One subject experienced a serious anaphylactoid reaction with laryngeal spasm and dyspnea [ see Warnings and Precautions (5.3) ].
Serious adverse reactions consisting of convulsions, pulmonary edema, acute necrotizing pancreatitis, and anaphylactoid reactions were reported in 0.1% of subjects in clinical trials.
5 WARNINGS AND PRECAUTIONS Hypersensitivity: anaphylactic/anaphylactoid reactions with cardiovascular, respiratory and cutaneous manifestations, ranging from mild to severe reactions including shock can occur.
Monitor patients closely for need of emergency cardiorespiratory support.
(5.3) Gadolinium is retained for months or years in brain, bone, and other organs.
(5.4) 5.1 Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures.
The safety and effectiveness of MultiHance have not been established with intrathecal use.
Like all medications, Multihance 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: