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 the labeling: Nephrogenic systemic fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Contraindications (4) and Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥ 0.5%) are nausea, headache, feeling hot, dizziness, and back pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc.
at 1-888-84-BAYER (1-888-842-2937) 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.
Adverse Reactions in Adults The safety of EOVIST was evaluated in 1,989 adult subjects who received EOVIST in clinical trials.
Overall, 59% of the subjects were male, and the racial and ethnic distribution was 64% White, 22% Asian, 3% Hispanic or Latino, 2% Black or African American, and 0.5% other ethnic groups.
The average age was 57 years (age range from 19 to 84 years).
Table 1 lists adverse reactions that occurred in ≥ 0.1% of subjects who received the recommended dose of EOVIST in clinical trials.
Table 1: Adverse Reactions Reported in ≥ 0.1% of Adult Subjects who Received EOVIST in Clinical Trials Adverse Reaction EOVIST n = 1,581 Rate (%) Nausea 1.1 Headache 1.1 Feeling hot 0.8 Dizziness 0.6 Back pain 0.6 Vomiting 0.4 Blood pressure increased 0.4 Injection site reactions (pain, burning, coldness, extravasation, irritation) 0.4 Dysgeusia 0.4 Paresthesia 0.3 Flushing 0.3 Parosmia 0.3 Pruritus (generalized, eye) 0.3 Rash 0.3 Respiratory disorders (dyspnea, respiratory distress) 0.2 Fatigue 0.2 Chest pain 0.1 Vertigo 0.1 Dry mouth 0.1 Chills 0.1 Feeling abnormal 0.1 Adverse reactions that occurred with a frequency of < 0.1% in subjects who received EOVIST include: tremor, akathisia, bundle branch block, palpitation, oral discomfort, salivary hypersecretion, maculopapular rash, hyperhidrosis, discomfort, and malaise.
Elevation of serum iron values and serum bilirubin laboratory values were reported in < 1% of subjects after administration of EOVIST.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Anaphylactic and other hypersensitivity 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 Retention: 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 EOVIST have not been established with intrathecal use.
EOVIST is not approved for intrathecal use [see Dosage and Administration (2.2) ].
Like all medications, Eovist 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: