Contrast Media Agents

Behind every image is a patient. We provide a comprehensive portfolio of contrast media to help meet patient and procedural needs across imaging modalities.

110m+

doses currently produced globally every year1

30m

more iodinated contrast media doses to be delivered annually by 20251

4 cGMP

accredited contrast media production facilities globally

$385m

invested over the last decade to increase capacity2

CONTRAST MEDIA

GE HealthCare has a distinguished history of contrast media development, offering a comprehensive product range across modalities, with a range of concentrations and innovative packaging choices.

INNOVATIVE PACKAGING

+PLUSPAK 100% recyclable packaging

Our +PLUSPAK packaging, used for certain contrast media products, is 100% recyclable. A life-cycle analysis showed that our polypropylene bottles, compared to glass, have a 59% lower environmental impact, and require 45% less cumulative energy. Our +PLUSPAK bottles, also require less secondary packaging, helping to reduce carbon footprint.3
IODINE RECYCLING

Protecting and optimizing iodine

We have been recycling iodine-based contrast media for healthcare facilities since 2006. Initially launched in Norway, we now offer this recycling program in 11 European countries and, in 2021, expanded it into Canada and the United States.4
References
1. GE HealthCare Data on File: Planned Investment; 2022
2. GE HealthCare Data on File: Contrast Media Demand; 2022
3. Dhaliwal et al. A life cycle assessment of packaging options for contrast media delivery: comparing polymer bottle vs. glass bottle. Int J Life Cycle Assess. 2014; 19: 1965-73.
4. GE HealthCare Data on File: Iodine-Recycling Program; 2022

JB08206US July 2024

Indications and Important Safety Information

Indications and Use – Omnipaque™ (iohexol)

Intrathecal Administration – Adults: Omnipaque 180, 240, and 300 • Myelography (lumbar, thoracic, cervical, total columnar) • Computed tomography (CT) (myelography, cisternography, ventriculography) Pediatrics: Omnipaque 180 • Myelography (lumbar, thoracic, cervical, total columnar) • CT (myelography, cisternography) Intravascular Administration – Adults: Omnipaque 140 • Intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels. Omnipaque 240 • CT head imaging • Peripheral venography (phlebography). Omnipaque 300 • Aortography including studies of the aortic arch, abdominal aorta and its branches • CT head and body imaging • Cerebral arteriography • Peripheral venography (phlebography) • Peripheral arteriography • Excretory urography. Omnipaque 350 • Angiocardiography (ventriculography, selective coronary arteriography) • Aortography, including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches • CT head and body imaging • Intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels • Peripheral arteriography • Excretory urography. Pediatrics: Omnipaque 240 • CT head and body imaging. Omnipaque 300 • Angiocardiography (ventriculography) • Excretory urography • CT head and body imaging. Omnipaque 350 • Angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) • Aortography, including the aortic root, aortic arch, ascending and descending aorta. Oral or Rectal Administration – Adults: Omnipaque 350 • Oral radiographic examination of the gastrointestinal tract. Pediatrics: Omnipaque 180, 240, and 300 • Oral and rectal radiographic examination of the gastrointestinal tract. Oral administration in conjunction with intravenous administration: Diluted Omnipaque Injection – Adults: Omnipaque 240, 300, and 350 diluted and administered orally in conjunction with Omnipaque 300 administered intravenously • CT of the abdomen. Pediatrics: Omnipaque 240, 300, and 350 diluted and administered orally in conjunction with Omnipaque 240 or Omnipaque 300 administered intravenously • CT of the abdomen. Omnipaque Oral Solution – Adults: Omnipaque Oral Solutions 9 and 12 administered orally in conjunction with Omnipaque 300 administered intravenously • CT of the abdomen. Pediatrics: Omnipaque Oral Solutions 9 and 12 administered orally in conjunction with Omnipaque 240 or Omnipaque 300 administered intravenously • CT of the abdomen. Intra-articular Administration – Adults: Omnipaque 240, 300, and 350 • Arthrography. Body Cavity Administration – Adults: Omnipaque 240 • Endoscopic retrograde pancreatography (ERP) and endoscopic retrograde cholangiopancreatography (ERCP) • Herniography • Hysterosalpingography. Omnipaque 300 • Hysterosalpingography. Pediatrics: Omnipaque 240, 300, and 350 diluted • Voiding cystourethrography (VCU).

IMPORTANT SAFETY INFORMATION ABOUT OMNIPAQUE™ (iohexol)

WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION OF

Omnipaque Injections 140 and 350 mgI/mL


Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.

CONTRAINDICATIONS:

• OMNIPAQUE 140 and OMNIPAQUE 350 are contraindicated for intrathecal use.
• OMNIPAQUE Oral Solutions 9 and 12 are contraindicated for parenteral administration.
• OMNIPAQUE body cavity 240 and 300 for hysterosalpingography is contraindicated during pregnancy (or suspected pregnancy), menstruation (or when menstruation is imminent), within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract, including the external genitalia, and when reproductive tract neoplasia is known or suspected.

WARNINGS AND PRECAUTIONS:

• Hypersensitivity Reactions: Life-threatening or fatal hypersensitivity reactions, including anaphylaxis can occur. Most severe reactions develop within 3 minutes of injection start, but reactions can occur hours later. Increased risk exists in patients with previous reaction to contrast agents and known allergies (ie, bronchial asthma, drug, food allergies) or other hypersensitivities. Always have emergency resuscitation equipment and trained personnel available. Monitor all patients for hypersensitivity reactions.
• Contrast-Induced Acute Kidney Injury: Acute injury, including renal failure, may occur after parenteral administration. Risk factors include renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant nephrotoxic or diuretic medications, multiple myeloma/paraproteinaceous diseases, and repetitive and/or large doses of an iodinated contrast agent. Minimize dose and maintain adequate hydration.
• Cardiovascular Adverse Reactions: Life-threatening or fatal cardiovascular reactions, including hypotension, shock, and cardiac arrest have occurred with the parenteral administration. Most deaths occur during injection or 5-10 minutes later, with cardiovascular disease as the main aggravating factor. Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography. Monitor all patients for severe cardiovascular reactions.
• Thromboembolic Events: Angiocardiography - Serious, rarely fatal, events causing myocardial infarction and stroke can occur during a procedure as increased thrombosis and activation of the complement system occurs. Risk factors include procedure length, catheter/syringe material, underlying disease, concomitant medications. Use meticulous angiographic techniques, minimize length of procedure. Avoid blood remaining in contact with syringes containing iodinated contrast agents. Avoid angiocardiography in patients with homocystinuria.
• Extravasation and Injection-Site Reactions: Extravasation during intravascular injection may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease. Ensure intravascular placement of catheters, monitor patients for extravasation, and advise patients to seek medical care for progression of symptoms.
• Thyroid Storm in Patients with Hyperthyroidism: Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule.
• Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media. Among patients 0 to 3 years of age exposed to iodinated contrast media, thyroid dysfunction has been reported in 1% to 15% depending on the age of the patient and the dose of the iodinated contrast agent. Monitor these patients for thyroid function abnormalities and treat as clinically needed.
• Hypertensive Crisis in Patients with Pheochromocytoma: Hypertensive crisis has occurred after the use of iodinated contrast agents in patients with pheochromocytoma. Inject the minimum amount of contrast necessary, assess the blood pressure throughout the procedure, and have measures for treatment of a hypertensive crisis readily available.
• Sickle Cell Crisis in Patients with Sickle Cell Disease: Iodinated contrast agents, when administered intravascularly, may promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following OMNIPAQUE administration and use OMNIPAQUE only if the necessary imaging information cannot be obtained with alternative imaging modalities.
• Severe Cutaneous Adverse Reactions (SCAR): SCAR may develop from 1 hour to several weeks after IV contrast administration. These include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase, and time to onset may decrease, with repeat administration of contrast agents; prophylactic medications may not prevent or mitigate SCARs. Avoid administering to patients with a history of a SCAR to OMNIPAQUE.

USE IN SPECIFIC POPULATIONS:
Please consult the full Prescribing Information before using OMNIPAQUE in patients who are: pregnant or may be pregnant, lactating, pediatric or geriatric.

ADVERSE REACTIONS:
• Intrathecal: Headaches, pain including backache, neckache, stiffness and neuralgia, nausea, vomiting, dizziness.
• Intravascular: Pain, vision abnormalities, (including blurred vision and photomas), headache, taste perversion, arrhythmias including premature ventricular contractions (PVCs) and premature atrial contractions (PACs), angina/chest pain, nausea.
• Oral:Diarrhea, nausea, vomiting, abdominal pain, flatulence, headache.
• Body cavity: Pain, swelling, heat sensation.
• Postmarketing adverse events seen include: Hypersensitivity and manifestations such as rash, pruritus, urticaria and dyspnea, chest pain, swelling.

DRUG-DRUG INTERACTIONS:

• Metformin: Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function in patients with renal impairment. Stop metformin at the time of, or prior to, injection of OMNIPAQUE. Reevaluate eGFR 48 hours after imaging procedure. Reinstitute metformin only after renal function is stable.
• Radioactive Iodine: Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy in patients with carcinoma of the thyroid.
• Beta-Adrenergic Blocking Agents: Use of beta-adrenergic blocking agents lowers the threshold for, and increases the severity of, contrast reactions and reduces the responsiveness of treatment of hypersensitivity reactions with epinephrine. Use caution when administering OMNIPAQUE to patients taking beta-blockers.
• Drugs That Lower Seizure Threshold: Drugs that lower seizure threshold, especially phenothiazine derivatives, including those used for their antihistaminic or antinauseant properties, are not recommended for use with intrathecal administration of OMNIPAQUE.
• Central Nervous System (CNS) Active Drugs: Drugs like monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, CNS stimulants, psychoactive drugs described as analeptics, major tranquilizers, or antipsychotic drugs should be discontinued at least 48 hours before myelography, should not be used for the control of nausea or vomiting during or after myelography, and should not be resumed for at least 24 hours post-procedure. In nonelective procedures in patients on these drugs, consider prophylactic use of anticonvulsants.

Prior to Omnipaque administration, please read the full Prescribing Information including Boxed Warning for Omnipaque. Also read the full Prescribing Information for Omnipaque Imaging Bulk Package and Omnipaque Pharmacy Bulk Package. 

To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2), or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.

IMPORTANT SAFETY INFORMATION FOR VISIPAQUE (iodixanol) INJECTION

 WARNING: NOT FOR INTRATHECAL USE
Inadvertent intrathecal administration may cause death, convulsions/seizures,
cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest,
rhabdomyolysis, hyperthermia, and brain edema.

CONTRAINDICATION: Visipaque injection is contraindicated for intrathecal use.

WARNINGS AND PRECAUTIONS:
• Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Most severe reactions develop shortly after the start of the injection, but reactions can occur up to hours later. Always have emergency equipment and trained personnel available.
• Contrast Induced Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk.
• Cardiovascular Reactions: Life-threatening or fatal cardiovascular reactions, including hypotension, shock, and cardiac arrest have occurred with the use of Visipaque. Most deaths occur during injection or five to ten minutes later, with cardiovascular disease as the main aggravating factor. Use the lowest necessary dose of Visipaque in patients with congestive heart failure.
• Thromboembolic Events: Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiocardiography procedures with both ionic and nonionic contrast agents.
• Extravasation and Injection Site Reactions: Extravasation of Visipaque injection may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease. Ensure intravascular placement of catheters prior to injection.
• Thyroid Storm in Patients With Hyperthyroidism: Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule.
• Hypertensive Crisis in Patients With Pheochromocytoma: Hypertensive crisis has occurred after the use of iodinated contrast agents in patients with pheochromocytoma. Inject the minimum amount of contrast necessary, assess the blood pressure throughout the procedure, and have measures for treatment of a hypertensive crisis readily available.
• Sickle Cell Crisis in Patients With Sickle Cell Disease: Iodinated contrast agents when administered intravascularly may promote sickling in individuals who are homozygous for sickle cell disease.
• Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCARs) may develop from one hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS). Avoid administering Visipaque to patients with a history of a SCAR to Visipaque.
• Pediatric Use: Pediatric patients at high risk of adverse reactions during and after administration of contrast agents include those with asthma, hypersensitivity to other medication and/or allergens, cyanotic and acyanotic heart disease, chronic heart failure, or a serum creatinine >1.5 mg/dL. Patients with immature renal function or dehydration may be at increased risk due to prolonged elimination of iodinated contrast agents. Thyroid dysfunction in pediatric patients 0 to 3 Years of Age: Monitor these patients for thyroid function abnormalities and treat as clinically needed.
• Geriatric Use: While no overall differences in safety or effectiveness were observed in patients >65 years, greater sensitivity regarding some older individuals cannot be ruled out.

ADVERSE REACTIONS:
• Serious, life-threatening, and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of iodine-containing contrast agents, including Visipaque Injection. 
• Most common adverse reactions (incidence greater than 0.5%) in adult patients after Visipaque injection: Discomfort, warmth, pain; Cardiovascular: angina. Gastrointestinal: diarrhea, nausea, vomiting. Nervous System: agitation, anxiety, insomnia, nervousness, dizziness, headache, migraine, unusual skin sensations, sensory disturbance, fainting, sensation of spinning. Skin: itchy rash, severe itching, hives. Special Senses: Smell, taste, and vision alteration. Pediatric patients experienced similar adverse reactions.

Please see the full Prescribing Information, including Boxed Warning for additional important safety information.
 
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1), or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.

 

Product Indications

Intra-Arterial Procedures
Adult and pediatric patients 12 years of age and older: Intra-arterial digital subtraction angiography (270 and 320 mg iodine/mL); angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg iodine/mL). Pediatric patients less than 12 years of age: Angiocardiography, cerebral arteriography, and visceral arteriography (320 mg iodine/mL)

Intravenous Procedures
Adult and pediatric patients 12 years of age and older: Computed tomography (CT) imaging of the head and body (270 and 320 mg iodine/mL); excretory urography (270 and 320 mg iodine/mL); peripheral venography (270 mg iodine/mL); coronary computed tomography angiography (CCTA) to assist in the diagnostic evaluation of patients with suspected  artery disease (320 mg iodine/mL). Pediatric patients less than 12 years of age: CT imaging of the head and body (270 mg iodine/mL); excretory urography (270 mgiodine/mL)

Please see full Prescribing Information for Visipaque and full Prescribing Information for Visipaque Bulk Package.

IMPORTANT SAFETY INFORMATION ABOUT CLARISCAN™ (GADOTERATE MEGLUMINE)

PRODUCT INDICATIONS AND USE:

Clariscan™ (gadoterate meglumine) is a prescription gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Risk Associated with Intrathecal Use
 Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Clariscan is not approved for intrathecal use.

Nephrogenic Systemic Fibrosis

GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of Clariscan in these patients unless the diagnostic information is essential and not available with noncontrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

The risk for NSF appears highest among patients with:
  • Chronic, severe kidney disease (GFR < 30 mL/min/1.73m²), or
  • Acute kidney injury.
Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g., age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended Clariscan dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

CONTRAINDICATIONS
History of clinically important hypersensitivity reactions to Clariscan.

WARNINGS AND PRECAUTIONS

  • 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 Clariscan have not been established with intrathecal use. Clariscan is not approved for intrathecal use.
  • Nephrogenic Systemic Fibrosis: GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of Clariscan among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.
  • Hypersensitivity Reactions: Anaphylactic and anaphylactoid reactions have been reported with Clariscan, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died.
  • Before Clariscan administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Clariscan.
  • Gadolinium Retention: Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by other organs (e.g. brain, skin, kidney, liver and spleen). While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible.
  • Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging
  • Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Clariscan. Extravasation into tissues during Clariscan administration may result in tissue irritation

 

ADVERSE REACTIONS

  • In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received Clariscan included: nausea, headache, injection site pain, injection site coldness and rash.
  • Serious adverse reactions in the postmarketing experience have been reported with Clariscan. Serious adverse reactions include but are not limited to arrhythmia, cardiac arrest, respiratory arrest, pharyngeal edema, laryngospasm, bronchospasm, coma, convulsion, and acute pancreatitis with onset within 48 hours post GBCA administration.

 

USE IN SPECIFIC POPULATIONS

  • Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. Use only if imaging is essential during pregnancy and cannot be delayed
  • Lactation: There are no data on the presence of gadoterate in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk.
  • Pediatric Use:The safety of Clariscan has not been established in preterm neonates. No dosage adjustment according to age is necessary in pediatric patients.
  • Geriatric Use: The use of Clariscan in elderly patients should be cautious, reflecting the greater frequency of impaired renal function and concomitant disease or other drug therapy. No age-related dosage adjustment is necessary.
  • Renal Impairment: No Clariscan dosage adjustment is recommended for patients with renal impairment.

 

To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or by email at gpv.drugsafety@gehealthcare.com  or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see CLARISCAN full Prescribing Information, including the Medication Guide, for additional important safety information.

IMPORTANT SAFETY INFORMATION

 WARNING: SERIOUS CARDIOPULMONARY REACTIONS
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration
• Assess all patients for the presence of any condition that precludes OPTISON administration
• Always have resuscitation equipment and trained personnel readily available
• CONTRAINDICATION: Do not administer OPTISON to patients with known or suspected hypersensitivity to perflutren or albumin.
• WARNINGS AND PRECAUTIONS: Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or shortly following administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias).
• Serious anaphylactic reactions have been observed during or shortly following perflutren-containing microsphere administration, including shock, hypersensitivity, bronchospasm, throat tightness, angioedema, edema (pharyngeal,palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema have occurred in patients with no prior exposure to perflutren-containing microsphere products.
• When administering Optison to patients with a cardiac shunt, microspheres can bypass filtering of the lungs and enter the arterial circulation. Assess patients with shunts for embolic phenomena following Optison administration.
• High ultrasound mechanical index values may cause microsphere rupture and lead to ventricular arrhythmias. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. Optison is not recommended for use at mechanical indices greater than 0.8.
• This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral disease.
• ADVERSE EVENTS: The most frequently reported adverse reactions in clinical trials were headache, nausea and/or vomiting, warm sensation or flushing and dizziness. Cardiac arrests and other serious but nonfatal adverse reactions were uncommonly reported in post-approval use. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions. Please see the full Prescribing Information, including Boxed Warning for additional important safety information.

To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1), or the FDA at 800 FDA 1088 or https://www.fda.gov/medwatch

IMPORTANT SAFETY INFORMATION ABOUT OMNISCAN™ (GADODIAMIDE)

PRODUCT INDICATIONS AND USE:

 

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 
  • Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space

 

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS 

 

  • Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. OMNISCAN is not approved for intrathecal use

     

  • GBCAs increase the risk for nephrogenic systemic fibrosis among patients with impaired elimination of the drugs. Avoid use of OMNISCAN in these patients unless the diagnostic information is essential and not available with noncontrasted MRI or other modalities. Do not administer OMNISCAN to patients with:  ○ chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or  ○ acute kidney injury. 

 

Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g., age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

 

CONTRAINDICATIONS

 

•     Patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m2) or acute kidney injury •       Patients with prior hypersensitivity to OMNISCAN

 

WARNINGS AND PRECAUTIONS

 

  • 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
  • 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. 
  • 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
  • Gadolinium is retained for months or years in brain, bone, and other organs 
  • 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

 

ADVERSE REACTIONS

 

  • The most frequent adverse reactions (≤ 3%) observed during OMNISCAN adult clinical studies were nausea, headache, and dizziness.
  • Serious or life-threatening reactions include: cardiac failure, arrhythmia and myocardial infarction

 

USE IN SPECIFIC POPULATIONS

 

Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed

 

To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or by email at gpv.drugsafety@gehealthcare.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Omniscan full Prescribing Information, including the Medication Guide, for additional important safety information.