Gadodiamide

Mechanism-of-action class: Magnetic Resonance Contrast Activity.

• OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues ( 1.1 ) Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space ( 1.2 ) 1.1 CNS (Central Nervous System) OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see Clinical Studies (14.1) ]. 1.2 Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions) OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see Clinical Studies (14.2) ].

• OMNISCAN is contraindicated in patients with: Chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m 2 ) or acute kidney injury Prior hypersensitivity to OMNISCAN Patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ) or acute kidney injury ( 4 ).contraindicated

CNS – Adults and Pediatrics; 2 to 16 years of age: 0.2 mL/kg (0.1 mmol/kg) ( 2.1 , 2.4 ) Body – Adults and Pediatrics; 2 to 16 years of age: Kidney: 0.1 mL/kg (0.05 mmol/kg) Intrathoracic, intra-abdominal, and pelvic cavities: 0.2 mL/kg (0.1 mmol/kg) ( 2.2 , 2.4 ) 2.1 CNS (Central Nervous System) Adults: The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection. Pediatric Patients (2 to 16 years of age): The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection [see Dosage and Administration (2.3) ]. 2.2 Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions) Adult and Pediatric Patients (2 to 16 years of age): For imaging the kidney, the recommended dose of OMNISCAN is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) [see Dosage and Administration (2.3) ]. 2.3 Dosage Chart BODY WEIGHT PEDIATRIC ADULTS 0.05 0.1 0.05 0.1 kg lb (mmol/kg) (mmol/kg) VOLUME (mL) VOLUME (mL) 12 26 1.2 2.4 - - 14 31 1.4 2.8 - - 16 35 1.6 3.2 - - 18 40 1.8 3.6 - - 20 44 2 4 - - 22 48 2.2 4.4 - - 24 53 2.4 4.8 - - 26 57 2.6 5.2 - - 28 62 2.8 5.6 - - 30 66 3 6 - - 40 88 4 8 4 8 50 110 5 10 5 10 60 132 6 12 6 12 70 154 7 14 7 14 80 176 8 16 8 16 90 198 - - 9 18 100 220 - - 10 20 110 242 - - 11 22 120 264 - - 12 24 130 The heaviest patient in clinical studies weighed 136 kg.

Hypersensitivity Reactions: Anaphylactoid and other serious hypersensitivity reactions including fatal reactions have occurred particularly in patients with history of allergy or drug reactions. 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 ). Acute Renal Failure: Acute renal failure has occurred in patients with preexisting renal insufficiency. Use the lowest necessary dose of OMNISCAN and evaluate renal function in these patients ( 5.5 ). 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 OMNISCAN have not been established with intrathecal use. OMNISCAN is not approved for intrathecal use [see Dosage and Administration (2.1 , 2.2) ]. 5.2 Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of OMNISCAN among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ) as well as patients with acute kidney injury. Do not administer OMNISCAN to these patients.

The following clinically significant 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) ] Acute Renal Failure [see Warnings and Precautions (5.5) ] The most frequent adverse reactions (≤ 3%) observed during OMNISCAN adult clinical studies were nausea, headache, and dizziness ( 6.1 ) Serious or life-threatening reactions include: cardiac failure, arrhythmia and myocardial infarction ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies 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. Adverse Reactions in Adult Patients In clinical studies 1,160 patients were exposed to OMNISCAN. The most frequent adverse reactions were nausea, headache, and dizziness that occurred in 3% or less of the patients. The majority of these reactions were of mild to moderate intensity. The following adverse reactions occurred in 1% or less of patients: Application Site Disorders: Injection site reaction. Autonomic Nervous System Disorders: Vasodilation.

Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed ( 8.1 ). 8.1 Pregnancy Risk Summary GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data ) . In animal reproduction studies, no adverse fetal effects were observed with administration of gadodiamide to pregnant rats during organogenesis at doses 1.3 times the maximum human dose based on body surface area (see Data ) . Because of the potential risks of gadolinium to the fetus, use OMNISCAN only if imaging is essential during pregnancy and cannot be delayed. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Contrast enhancement is visualized in the human placenta and fetal tissues after maternal GBCA administration. Cohort studies and case reports on exposure to GBCAs during pregnancy have not reported a clear association between GBCAs and adverse effects in the exposed neonates.

Metabolism

The pharmacokinetics of intravenously administered gadodiamide in normal subjects conforms to an open, two-compartment model with mean distribution and elimination half-lives (reported as mean ± SD) of 3.7 ± 2.7 minutes and 77.8 ± 16 minutes, respectively. Gadodiamide is eliminated primarily in the urine with 95.4 ± 5.5% (mean ± SD) of the administered dose eliminated by 24 hours.

Clinical consequences of overdose with OMNISCAN have not been reported. The minimum lethal dose of intravenously administered OMNISCAN in rats and mice is greater than 20 mmol/kg (200 times the recommended human dose of 0.1 mmol/kg; 67 times the cumulative 0.3 mmol/kg dose). OMNISCAN is dialyzable.

• Jan 8, 1993NDANDA020123Ge Healthcare

1. 1Nephrogenic Systemic Fibrosis2,22566%
2. 2Pain75723%
3. 3Anxiety43213%
4. 4Emotional Distress39812%
5. 5Injury39712%
6. 6Mobility Decreased35511%
7. 7Arthralgia34510%
8. 8Skin Hypertrophy2758.2%
9. 9Fibrosis2738.2%
10. 10General Physical Health Deterioration2718.1%
11. 11Skin Induration2667.9%
12. 12Oedema Peripheral2647.9%
13. 13Rash2597.7%
14. 14Hypoaesthesia2587.7%
15. 15Asthenia2547.6%

The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Gadodiamide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
  Recruiting · Phase 4 · Interventional · 2,076 enrolled · Guerbet
  NCT04373564updated 2026-01-22
• Safety Evaluation of Linear and Macrocyclic Gadolinium Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging
  Unknown · Phase 4 · Interventional · 600 enrolled · The Central Hospital of Lishui City
  NCT04776187updated 2021-03-01
• A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide
  Completed · Phase 3 · Interventional · 407 enrolled · GE Healthcare
  NCT00209443updated 2019-04-25
• A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide
  Completed · Phase 3 · Interventional · 395 enrolled · GE Healthcare
  NCT00209391updated 2019-04-25
• Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer
  Terminated · Interventional · 2 enrolled · OHSU Knight Cancer Institute
  NCT02501759updated 2019-04-03
• Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
  Completed · Phase 4 · Interventional · 213 enrolled · GE Healthcare
  NCT00908310updated 2014-07-17
• Early Detection of Glioblastoma Multiforme (GBM) Treatment Responses Using Multiple Magnetic Resonance Modalities
  Terminated · Observational · 5 enrolled · Yale University
  NCT00589095updated 2014-07-02
• A Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging
  Completed · Phase 3 · Interventional · 533 enrolled · Amersham Buchler, GmbH & Co KG
  NCT00977093updated 2009-09-15
• A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain
  Completed · Phase 4 · Interventional · 114 enrolled · Bracco Diagnostics, Inc
  NCT00323102updated 2008-01-23

Frequently asked questions

How does Gadodiamide work?

Mechanism-of-action class: Magnetic Resonance Contrast Activity.

What is Gadodiamide used for?

According to FDA labeling, Gadodiamide carries indications including: OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues ( 1.1 ) Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space ( 1.2 ) 1.1 CNS (Central Nervous System) OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see Clinical Studies (14.1) ]. 1.2 Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions) OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see Clinical Studies (14.2) ].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Gadodiamide?

Gadodiamide is classified as Paramagnetic contrast media, Paramagnetic Contrast Agent, Magnetic Resonance Contrast Activity.

What are the contraindications for Gadodiamide?

Gadodiamide labeling lists contraindications including: OMNISCAN is contraindicated in patients with: Chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m 2 ) or acute kidney injury Prior hypersensitivity to OMNISCAN Patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ) or acute kidney injury ( 4 ).. Always consult the full prescribing information and a clinician.