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 clinically significant adverse reactions are discussed elsewhere in labeling: • Nephrogenic Systemic Fibrosis (NSF) [see Boxed Warning and Warnings and Precautions ( 5.2 )] .
• Hypersensitivity reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] .
• Acute Respiratory Distress Syndrome [see Warnings and Precautions ( 5.4 )] .
• Gadolinium Retention [see Warnings and Precautions ( 5.5 )] .
Most common adverse reactions (incidence ≥ 0.5%) are headache, nausea, and dizziness ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 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 clinical practice.
The adverse reactions described in this section reflect gadobutrol injection exposure in 7,713 subjects (including 184 pediatric patients, ages 0 to 17 years) with the majority receiving the recommended dose.
Approximately 52% of the subjects were male and the ethnic distribution was 62% Caucasian, 28% Asian, 5% Hispanic, 2.5% Black, and 2.5% patients of other ethnic groups.
The average age was 56 years (range from 1 week to 93 years).
Overall, approximately 4% of subjects reported one or more adverse reactions during a follow-up period that ranged from 24 hours to 7 days after gadobutrol injection administration.
Adverse reactions associated with the use of gadobutrol injection were usually mild to moderate in severity and transient in nature.
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have occurred.
Monitor patients closely during and after administration of gadobutrol injection.
( 5.3 ) • Acute Respiratory Distress Syndrome: For Patients demonstrating respiratory distress after administration, assess oxygen requirement and monitor for worsening respiratory function.
( 5.4 ) • Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs.
( 5.5 ) 5.1 Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures.
Like all medications, Gadobutrol 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: