Adult Dosing

MRI contrast agent (CNS)

• CNS imaging: 0.2 mL/kg IV bolus

MRI contrast agent (body)

• Intrathoracic (noncardiac), intra-abdominal, and pelvic cavities imaging: 0.2 mL/kg IV bolus
• Kidney imaging: 0.1 mL/kg IV bolus

Pediatric Dosing

MRI contrast agent (CNS)

• Patients 2-16 years (CNS imaging): 0.2 mL/kg IV bolus

MRI contrast agent (body)

• Patients 2-16 years (Intrathoracic (noncardiac), intra-abdominal, and pelvic cavities imaging): 0.2 mL/kg IV bolus
• Patients 2-16 years (Kidney imaging): 0.1 mL/kg IV bolus

[Outline]

• Adult Dosing
• Pediatric Dosing

• MRI contrast agent used to visualize lesions with abnormal vascularity in the brain, spine, and associated tissues and facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space

• Hypersensitivity to any of the ingredients of the product
• Acute kidney injury
• Patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73 m²)

• Not for intrathecal use
• Inadvertent intrathecal use of gadodiamide has caused convulsions, coma, sensory and motor neurologic deficits
• Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use unless diagnostic information is essential and not available with non-contrasted MRI
• Avoid use in patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73 m² or acute kidney injury
• Screen for acute kidney injury and renal dysfunction, do not exceed recommended dosage
• 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

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Therapy is not indicated for intrathecal use. Inadvertent intrathecal use has caused convulsions, coma, sensory and motor neurologic deficits [US black box warning]
• Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use unless diagnostic information is essential and not available with non-contrasted MRI. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs [US black box warning]
• Avoid use in patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73 m² or acute kidney injury [US black box warning]
• Screen for acute kidney injury and renal dysfunction, do not exceed recommended dosage [US black box warning]
• 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 [US black box warning]
• Anaphylactoid and anaphylactic reactions, with cardiovascular, respiratory and/or cutaneous manifestations, resulting in death have occurred. Observe patients closely, particularly those with a history of drug reactions, asthma, allergy or other hypersensitivity disorders, during and up to several hours after administration
• In patients with renal insufficiency, acute renal failure requiring dialysis or worsening renal function have occurred. Risk may increase with increasing dose, use lowest possible dose of contrast and evaluate renal function in patients with renal insufficiency
• Therapy may impair the visualization of lesions which are seen on the non-contrast MRI
• Asymptomatic, transitory changes in serum iron have been observed

Pregnancy Category:C

Breastfeeding: Safety unknown; because of the potential for possible serious adverse reactions in nursing infants a decision should be made to discontinue breastfeeding, or to discontinue the drug taking into account the importance of the drug to the mother.

• CNS: Fever, hot flushes, convulsions rigors, fatigue, malaise, syncope, abnormal coordination, paresthesia, tremor, aggravated multiple sclerosis, aggravated migraine, ataxia
• GI: Abdominal pain, diarrhea, eructation, dry mouth/vomiting, melena, taste loss, taste perversion
• CV: Cardiac failure, arrhythmia, myocardial infarction, ischemic heart disease, flushing, chest pain, deep thrombophlebitis
• NEURO: Vasodilation
• MUSC: Arthralgia, myalgia, pain
• GU: Acute reversible renal failure
• EENT: Abnormal vision, tinnitus
• RESP: Rhinitis, dyspnea
• DERM: Pruritus, rash, erythematous rash, sweating increased, urticaria
• HYPERSENSITIVITY: Anaphylactoid reaction, injection site reaction

• Contrast agent; paramagnetic agent with unpaired electron spins which generate a local magnetic field
• Metabolism: Unkown
• Excretion: Primarily in the urine
• Half-life: 77.8 +/- 16 minutes

US Trade Name(s)

• Omniscan

US Availability

Omniscan

• PWDR for INJ: 287 mg/mL

Canadian Trade Name(s)

• Omniscan

Canadian Availability

Omniscan

• PWDR for INJ: 287 mg/mL

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

Omniscan

• PWDR for INJ: 287 mg/mL

[Outline]

Radiologic

Diagnostic Agents