EOVIST
Generic: GADOXETATE DISODIUM
Basic Information
Manufacturer
Bayer HealthCare Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
6218b1e1-cbc3-4c14-bec7-528ac163a561
Indications & Usage
1 INDICATIONS AND USAGE EOVIST is indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease.
EOVIST is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease.
( 1 )
EOVIST is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease.
( 1 )
Adverse Reactions
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.
The values did not exceed more than 3 times the baseline values and returned to baseline within 1 to 4 days.
Adverse Reactions in Pediatric Patients In a study of EOVIST in 52 pediatric patients between 2 months of age and 18 years of age, no new safety signals were observed [see Use in Specific Populations (8.4) ].
6.2 Postmarketing Experience The following additional adverse reactions have been identified during the postmarketing use of EOVIST or other GBCAs.
Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac Disorders: Tachycardia Gastrointestinal Disorders: Acute pancreatitis with onset within 48 hours after GBCA administration General Disorders and Administration Site Conditions: Fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems with variable onset and duration after GBCA administration [see Warnings and Precautions (5.4) ] Immune System Disorders: Hypersensitivity reactions (anaphylactic shock, hypotension, pharyngolaryngeal edema, urticaria, face edema, rhinitis, conjunctivitis, abdominal pain, hypoesthesia, sneezing, cough and pallor) Psychiatric Disorders: Restlessness Renal Disorders: Nephrogenic systemic fibrosis Respiratory, Thoracic, and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema Skin Disorders: Gadolinium associated plaques
( 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.
The values did not exceed more than 3 times the baseline values and returned to baseline within 1 to 4 days.
Adverse Reactions in Pediatric Patients In a study of EOVIST in 52 pediatric patients between 2 months of age and 18 years of age, no new safety signals were observed [see Use in Specific Populations (8.4) ].
6.2 Postmarketing Experience The following additional adverse reactions have been identified during the postmarketing use of EOVIST or other GBCAs.
Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac Disorders: Tachycardia Gastrointestinal Disorders: Acute pancreatitis with onset within 48 hours after GBCA administration General Disorders and Administration Site Conditions: Fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems with variable onset and duration after GBCA administration [see Warnings and Precautions (5.4) ] Immune System Disorders: Hypersensitivity reactions (anaphylactic shock, hypotension, pharyngolaryngeal edema, urticaria, face edema, rhinitis, conjunctivitis, abdominal pain, hypoesthesia, sneezing, cough and pallor) Psychiatric Disorders: Restlessness Renal Disorders: Nephrogenic systemic fibrosis Respiratory, Thoracic, and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema Skin Disorders: Gadolinium associated plaques