Version May 2024
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) among 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 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/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 of age, hypertension, diabetes), estimate the GFR through laboratory testing.
For patients at highest risk for NSF, do not exceed the recommended gadopiclenol dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration.
MRI, CNS and body imaging: Dose based on actual body weight.
Children ≥2 years and Adolescents: IV: 0.05 mmol/kg (0.1 mL/kg); may begin imaging immediately after administration.
Children ≥2 years and Adolescents: Note: Risk of nephrogenic systemic fibrosis (NSF) increases as renal function decreases. Consider risks versus benefits of diagnostic information prior to use.
Mild to severe impairment: No dose adjustment recommended; avoid use when diagnostic information is not essential.
Hemodialysis: Dialyzable; in patients receiving hemodialysis, consider initiation of dialysis immediately following administration to enhance gadopiclenol elimination. Hemodialysis removes gadopiclenol from plasma at rates of 95% to 98% and 100% after the first and third hemodialysis sessions, respectively.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
(For additional information see "Gadopiclenol: Drug information")
Body and CNS imaging: IV: 0.05 mmol/kg (0.1 mL/kg) based on actual body weight as a single dose.
No dosage adjustment necessary, although there is increased exposure in patients with renal impairment (use is generally not recommended). In patients receiving hemodialysis, consider initiation of dialysis immediately following administration to enhance gadopiclenol elimination.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults.
<1%:
Dermatologic: Allergic dermatitis, erythema of skin, maculopapular rash, pruritus
Gastrointestinal: Diarrhea, dysgeusia, nausea, oral paresthesia, vomiting
Local: Injection-site reaction (including injection-site coldness, injection-site paresthesia, pain at injection site, swelling at injection site, warm sensation at injection site)
Nervous system: Dizziness, feeling hot, headache
Renal: Renal function test abnormality (including increased Cystatin C and increased serum creatinine), renal insufficiency (worsening of)
Miscellaneous: Fever
Frequency not defined: Renal: Nephrogenic systemic fibrosis
Hypersensitivity to gadopiclenol or any component of the formulation.
Concerns related to adverse effects:
• Gadolinium retention: Gadolinium is retained for months or years in the brain, bone, skin, and other organs (kidney, liver, spleen); the highest concentration and longest duration have been found in the bone. Linear gadolinium-based contrast agents (GBCAs) (gadodiamide, gadoxetate disodium, gadobenate dimeglumine) result in more retention than macrocyclic GBCAs (gadoterate meglumine, gadobutrol, gadopiclenol, gadoteridol); among the linear agents, gadolinium retention varies, with gadodiamide causing greater retention than other linear agents. Pathologic and clinical consequences of gadolinium retention in skin and other organs have been established in patients with impaired kidney function; there also have been rare reports of pathologic skin changes in patients with normal kidney function. Consequences of gadolinium retention in the brain or in patients with normal kidney function have not been established. Patients with normal kidney 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: Hypersensitivity, including serious reactions, may occur; most reactions occurred within minutes of administration and resolved with emergency treatment. Appropriate equipment (eg, ventilator) and emergency medications (eg, epinephrine) should be available during use. Patients with a history of allergic reactions and/or bronchial asthma may be at an increased risk for developing hypersensitivity reactions; use caution in these patients.
• Nephrogenic systemic fibrosis: [US Boxed Warning]: Risk of gadolinium-based contrast agent associated nephrogenic systemic fibrosis (NSF) is highest in patients with chronic, severe kidney dysfunction (GFR <30 mL/minute/1.73m2) and acute kidney injury. Avoid use unless diagnostic information cannot be obtained without use of a contrast MRI. Risk appears lower in patients with moderate, chronic kidney disease (GFR 30 to 59 mL/minute/1.73 m2) and little, if any, in patients with mild, chronic kidney disease (GFR 60 to 89 mL/minute/1.73 m2). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Screen all patients for kidney dysfunction prior to administration; estimate GFR in patients at risk for chronic kidney disease (diabetes, chronic hypertension, age >60 years). In patients at risk of NSF, do not exceed the recommended dosage and allow sufficient time (ie, several half-lives) for elimination prior to readministration (avoidance of readministration is preferred). In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration to enhance contrast elimination.
Disease-related concerns:
• Kidney impairment: Use with caution in patients with kidney impairment. Dose-dependent worsening of kidney function and acute kidney injury requiring dialysis have occurred.
Other warnings/precautions:
• Extravasation and injection-site reactions: Extravasation and injection-site reactions have occurred during administration. Ensure catheter and venous patency prior to administration.
• Scan interpretation: Use caution when interpreting a contrast-enhanced scan in the absence of a companion noncontrast MRI scan.
Vueway: FDA approved September 2022; anticipated availability currently unknown.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
Elucirem: 0.5 mmol/mL (3 mL, 7.5 mL, 10 mL, 15 mL, 30 mL, 50 mL, 100 mL)
Vueway: 0.5 mmol/mL (3 mL, 7.5 mL, 10 mL)
Solution, Intravenous [preservative free]:
Vueway: 0.5 mmol/mL (3 mL [DSC], 7.5 mL [DSC], 10 mL [DSC], 30 mL)
No
Solution (Elucirem Intravenous)
0.5 mmol/mL (per mL): $13.25
Solution (Vueway Intravenous)
0.5 mmol/mL (per mL): $13.46
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: For IV use only. Solution should be clear and colorless to yellow without particulates. Prime IV line before administration. Administer as a bolus injection at ~2 mL/second. Flush line with NS to ensure complete injection. Imaging can begin immediately after administration.
Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. If extravasation occurs, stop infusion immediately and disconnect; remove needle/cannula; elevate extremity. Aspiration of extravasated contrast media is not recommended (ACR 2022). Information is conflicting regarding the use of hyaluronidase; the American College of Radiology (ACR) Manual on Contrast Media does not recommend hyaluronidase in the management of contrast media extravasation (ACR 2022); other sources suggest its utility in extravasation management (see Management of Drug Extravasations for details) (Bellin 2002; Reynolds 2014).
IV: For IV use only. Solution should be clear and colorless to yellow without particulates; if solidification occurs with vials, bring vial and bulk package to room temperature before use. Prime IV line before use. Administer as a bolus injection at a rate of ~2 mL/second; if administering using a prefilled syringe, discard any unused portion following injection. Flush line with NS after administration to ensure complete injection of the contrast medium. Imaging can begin immediately following injection.
Extravasation management: If extravasation occurs, stop infusion immediately and disconnect; remove needle/cannula; elevate extremity. Aspiration of extravasated contrast media is not recommended. Information conflicts regarding the use of hyaluronidase; the American College of Radiology (ACR) Manual on Contrast Media does not recommend hyaluronidase in the management of contrast media extravasation (Ref); other sources suggest its utility in extravasation management for inoperable cases with compartment syndrome (Ref).
If using hyaluronidase: Intradermal or SUBQ: Dose varies based on the size of infiltration; inject a total of 5 to 250 units (~100 mL contrast reabsorbed per 15 units of hyaluronidase) around the site of extravasation (Ref).
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze prefilled syringes (discard prefilled syringes if frozen); if solidification occurs in vial due to cold exposure, bring to room temperature before use. If drawn into a plastic disposable syringe for administration, use immediately after preparation. Discard any unused portion of vial or prefilled syringe. Pharmacy bulk package should only be entered once and must be discarded within 24 hours after opening in a sterile environment.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Elucirem: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216986s000lbl.pdf#page=17
For use with MRI to detect and visualize lesions with abnormal vascularity in the CNS (brain, spine, and associated tissues) and body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) (FDA approved in ages ≥2 years and adults).
None known.
There are no known significant interactions.
Evaluate pregnancy status prior to the use of gadolinium-based contrast agents in patients who may become pregnant (ACR 2022).
Gadolinium-based contrast agents may cross the placenta (ACOG 2017; ACR 2022).
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 2022).
Prior to administration: Kidney function (BUN, SCr, urine output).
During and after administration: Signs of hypersensitivity; monitor injection site for signs/symptoms of extravasation; signs/symptoms of nephrogenic systemic fibrosis (eg, burning, itching, swelling, scaling, hardening and/or tightening of skin, joint stiffness, deep hip or rib bone pain, muscle weakness, limited range of motion, and/or yellowed/raised spots on whites of eye).
Gadopiclenol is a paramagnetic molecule (macrocyclic non-ionic complex of gadolinium). When gadopiclenol is placed in a magnetic field, it develops a magnetic moment that relaxes water protons around it in the body leading to an increase in brightness of tissues.
Distribution: 13 L.
Protein binding: ≤1.8%.
Metabolism: Not metabolized.
Half-life elimination:
Children 2 to 6 years: Median: 1.29 hours (range: 0.69 to 3.38 hours).
Children 7 to 11 years: Median: 1.48 hours (range: 0.83 to 3.2 hours).
Children ≥12 years and Adolescents ≤17 years: Median: 1.77 hours (range: 1 to 3.57 hours).
Adults: Mean: 1.5 hours.
Excretion: Urine (~98% within 48 hours).
Altered kidney function: Following a single 0.1 mmol/kg dose (2 times the recommended dose) to patients with estimated GFR of 15 to 90 mL/minute, clearance decreased and half-life increased in correlation with the degree of kidney impairment. Hemodialysis reduced blood concentrations by 95% to 98% after the first session and by 100% after the third session.
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