Version May 2024
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis in patients with impaired elimination of the drugs. Avoid use of gadolinium-based contrast agents in these patients unless the diagnostic information is essential and not available with noncontrast-enhanced magnetic resonance imaging (MRI) or other modalities. Nephrogenic systemic fibrosis may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. The risk for nephrogenic systemic fibrosis appears highest among patients with chronic, severe kidney disease (glomerular filtration rate [GFR] <30 mL/minute/1.73 m2), 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 (eg, >60 years, hypertension, diabetes), estimate the GFR through laboratory testing. For patients at highest risk for nephrogenic systemic fibrosis, do not exceed the recommended gadoteridol dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration.
CNS imaging: IV: 0.1 mmol/kg (0.2 mL/kg); if needed, a second dose of 0.2 mmol/kg (0.4 mL/kg) may be repeated once within 30 minutes of the first dose.
Extracranial/extraspinal head and neck imaging: IV: 0.1 mmol/kg (0.2 mL/kg).
No dosage adjustment necessary. Risk for nephrogenic systemic fibrosis development increases as renal function decreases.
Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Kuo 2007). Data has been shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first, second, and third hemodialysis sessions, respectively (Kuo 2007; Okada 2001).
Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Joffe 1998; Kuo 2007).
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Gadoteridol: Pediatric drug information")
CNS imaging: Infants, Children, and Adolescents: IV: 0.1 mmol/kg (0.2 mL/kg).
Infants, Children, and Adolescents: No dosage adjustment necessary; use with caution in patients with kidney impairment or at high risk; risk for nephrogenic systemic fibrosis (NSF) development increases as renal function decreases.
Dialysis: There are no pediatric-specific recommendations; based on experience in adult patients, the following has been observed:
Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Kuo 2007). Data has been shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first, second, and third hemodialysis sessions, respectively (Kuo 2007; Okada 2001).
Peritoneal dialysis: Based on data in adult patients, peritoneal dialysis is likely to be less efficient at clearing gadolinium than hemodialysis (Joffe 1998; Kuo 2007).
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%: Gastrointestinal: Nausea (1%)
<1%:
Cardiovascular: Angina pectoris, chest tightness, cold extremity, facial edema, first degree atrioventricular block, flushing, hypotension, increased heart rate, palpitations, presyncope, syncope, vascular injury (rupture), vasodilation, vasospasm
Dermatologic: Hyperhidrosis, morbilliform rash, pruritus, skin rash, urticaria
Endocrine & metabolic: Decreased blood urea nitrogen, hyperchloremia, hypoglycemia
Gastrointestinal: Abdominal distress, abdominal pain, decreased appetite, diarrhea, dysgeusia, gingival pain, gingivitis, oral itching, swollen tongue, vomiting, xerostomia
Hematologic & oncologic: Decreased hemoglobin
Hepatic: Increased serum alanine aminotransferase, increased serum aspartate aminotransferase
Local: Injection site reaction (including erythema at injection site, sensation of cold, pain at injection site, warm sensation at injection site)
Nervous system: Anxiety, dizziness, feeling hot, formication, headache, hypoesthesia, lethargy, loss of consciousness, mental status change, migraine, pain, paresthesia, seizure, taste disorder
Neuromuscular & skeletal: Asthenia, back pain, hypokinesia, muscle rigidity
Ophthalmic: Eye pruritus, increased lacrimation
Otic: Ear sign and symptom (discomfort), tinnitus
Respiratory: Cough, dry throat, dyspnea, nasal discomfort, rhinitis, throat irritation
Miscellaneous: Fever
Frequency not defined: Renal: Nephrogenic systemic fibrosis
Postmarketing:
Cardiovascular: Bradycardia, hypertension, vasodepressor syncope
Hypersensitivity: Anaphylaxis, hypersensitivity reaction (including angioedema, bronchospasm, cyanosis, eyelid edema, pharyngeal edema), nonimmune anaphylaxis (including circulatory shock)
Nervous system: Coma
Neuromuscular & skeletal: Tremor
Renal: Acute kidney injury
Respiratory: Pulmonary edema
Hypersensitivity to gadoteridol or any component of the formulation
Concerns related to adverse effects:
• Gadolinium retention: Gadolinium is retained for months or years in brain, bone, skin, and other organs (kidney, liver, spleen); the highest concentration and longest duration have been found in the bone. Linear GBCAs (gadodiamide and gadoversetamide > gadoxetate disodium, gadopentetate dimeglumine, and gadobenate dimeglumine) result in more retention than macrocyclic GBCAs (gadoterate meglumine, gadobutrol, and gadoteridol). Pathologic and clinical consequences of gadolinium retention in skin and other organs have been established in patients with impaired renal function; there also have been rare reports of pathologic skin changes in patients with normal renal function. Consequences of gadolinium retention in the brain or in patients with normal renal function have not been established. Patients with normal renal function that may be at higher risk for gadolinium retention include: patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions; take GBCA retention characteristics into consideration for these patients. Minimize repetitive GBCA imaging studies.
• Hypersensitivity reactions: Severe and fatal hypersensitivity reactions, including anaphylaxis and anaphylactoid reactions involving cardiovascular, cutaneous, and/or respiratory symptoms, have occurred. Patients with a history of allergic reactions, asthma, or other hypersensitivity-like disorders may be at increased risk. Closely observe patients during and for up to 2 hours after the procedure. If hypersensitivity reaction occurs, discontinue gadoteridol immediately and have appropriate equipment (eg, ventilator) and emergency medications (eg, epinephrine) available during use.
• Nephrogenic systemic fibrosis: [US Boxed Warning]: Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs; avoid use in these patients unless diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest in patients with acute kidney injury or chronic, severe renal disease (glomerular filtration rate [GFR] <30 mL/minute/1.73 m2). Screen patients for acute kidney injury and other conditions that may reduce renal function; estimate GFR in patients at risk for chronically reduced renal function (eg, diabetes, hypertension, >60 years). For patients at highest risk for NSF, do not exceed the recommended dose and allow a sufficient period of time for elimination of the drug from the body prior to readministration. The risk for NSF appears lower in patients with moderate, chronic renal disease (GFR 30 to 59 mL/minute/1.73 m2) and little, if any, in patients with mild, chronic renal disease (GFR 60 to 89 mL/minute/1.73 m2). In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment. Dose-dependent worsening of renal function or acute renal failure has occurred in patients with renal insufficiency following use of gadolinium agents, generally within 48 hours following administration. In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred; risk of acute kidney injury may increase with increasing dose; administer the lowest dose necessary. Evaluate renal function in patients with renal impairment prior to use; consider follow-up monitoring.
Other warnings/precautions:
• Experienced physician: Physicians should be experienced with diagnostic procedures using contrast agents.
• Repeat doses: Repeated procedures have not been studied; safety of sequential doses has only been studied in adults in central nervous system during the same diagnostic session.
ProHance prefilled syringe tip cap contains latex.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
Prohance: 279.3 mg/mL (5 mL, 10 mL, 15 mL, 17 mL [DSC], 20 mL, 50 mL)
No
Solution (Prohance Intravenous)
279.3 mg/mL (per mL): $6.81
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Prohance: 279.3 mg/mL (5 mL, 10 mL)
Administer as a rapid infusion (10 to 60 mL/minute) or as a bolus (>60 mL/minute). Flush line with NS 5 mL to ensure complete injection of medium. Imaging should be completed within 60 minutes of injection.
IV: Administer as a rapid infusion (10 to 60 mL/minute) or as a bolus (>60 mL/minute). Flush line with at least 5 mL NS to ensure complete injection of medium. Imaging should be completed within 60 minutes of injection.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Prohance: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021489s014lbl.pdf#page=16
CNS imaging: For use in MRI in adults and pediatric patients (including term neonates) to visualize lesions with disrupted blood-brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine, and associated tissues.
Extracranial/Extraspinal head and neck imaging: For use in MRI in adults to visualize lesions in the head and neck.
Magnetic resonance angiography (MRA)
None known.
There are no known significant interactions.
Gadolinium-based contrast agents may cross the placenta (ACOG 2017; ACR 2020).
Pregnant patients may be at increased risk for gadolinium retention. Use of gadolinium-based contrast agents in pregnancy is controversial and should be limited. A gadolinium-based contrast agent with MRI may be considered for use in pregnancy if it will significantly improve diagnostic performance and is expected to improve fetal or maternal outcome (ACOG 2017). In addition, use should only be considered if information needed from the MRI study cannot be acquired without using a contrast agent and cannot be deferred until after delivery. Agents with a low risk for development of nephrogenic systemic fibrosis should be used at the lowest effective dose (ACR 2020).
Gadolinium-based contrast agents may be present in breast milk (ACOG 2017; ACR 2020).
Because of the low expected excretion into breast milk and the low absorption from an infant's GI tract, breastfeeding may be continued without interruption after use (ACOG 2017; ACR 2020). Theoretically, the taste of milk could be altered if it contains contrast media. Women who prefer to temporarily withhold breastfeeding may express and discard milk from both breasts during a period of 12 to 24 hours after the administration of contrast media. They can pump and store milk prior to the procedure then bottle feed using the stored milk during this time (ACR 2020). According to the manufacturer, the decision to breastfeed should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Signs/symptoms of hypersensitivity (during and for several hours after procedure); renal function (prior to administration and as clinically indicated); signs/symptoms of NSF (during and following procedure); signs/symptoms of acute kidney injury.
Gadoteridol is a gadolinium-containing paramagnetic agent. Exposure to an external magnetic field induces a large local magnetic field in exposed tissues. This local magnetism disrupts water protons in the vicinity, resulting in a change in proton density and spin characteristics, which can be detected by the imaging device.
Distribution: Vd: 204 ± 58 mL/kg; distribution half-life: 0.2 ± 0.04 hours
Half-life elimination: 1.57 ± 0.08 hours
Excretion: Urine (~94%)
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