Gadopiclenol
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Vueway is not approved for intrathecal use [see Warnings and Precautions ( 5.1 )] . Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Vueway in these patients unless the diagnostic information is essential and not available with non-contrasted 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/1.73 m 2 ), 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 Vueway dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions ( 5.2 )] . WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Vueway is not approved for intrathecal use.
( 5.1 ) GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Vueway in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR <30 mL/min/1.73 m 2 ), 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 (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
( 5.2 )
Dosing in kidney impairment
Renal Impairment In patients with renal impairment, the exposure of gadopiclenol is increased compared to patients with normal renal function. This may increase the risk of adverse reactions such as nephrogenic systemic fibrosis (NSF). Avoid use of Vueway among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.
No dose adjustment of Vueway is recommended for patients with renal impairment. Vueway can be removed from the body by hemodialysis [see Warnings and Precautions ( 5.2 , 5.4 , 5.5 ) and Clinical Pharmacology] .
Preparation and administration
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Administration and Imaging Instructions Administer Vueway as an intravenous bolus injection, manually or by compatible power injector, at approximately 2 mL/sec followed by a flush of 0.9% sodium chloride injection. For pediatric patients, adjust the flow rate and flush volume based on age. Use aseptic technique for all handling and administration of Vueway.
Visually inspect Vueway for particulate matter and discoloration prior to administration. Do not use the solution if any particulate matter is present or the solution is discolored. Do not mix with other medications because of the potential for chemical incompatibility. Prime intravenous line before use. Contrast MRI can begin immediately following the injection of Vueway.
Directions for Use of Pharmacy Bulk Package Vueway Pharmacy Bulk Package (PBP) is not for direct infusion. Perform the transfer of Vueway from the PBP in an aseptic work area, such as laminar flow hood, using aseptic technique and suitable transfer device for filling empty sterile syringes. Penetrate the closure only one time.
Once the container closure is punctured, do not remove the PBP from the aseptic work area. Use each individual dose of Vueway promptly following withdrawal from the PBP. Use the contents of the PBP within 24 hours at room temperature after puncture. If solidification occurs in the PBP due to cold exposure, bring the PBP of Vueway to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration.
Directions for Use of Imaging Bulk Package Vueway Imaging Bulk Package (IBP) is not for direct infusion. The IBP is for use with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this IBP. This allows for the administration of multiple single doses of Vueway to multiple patients.
See drug and device labeling for information on devices indicated for use with this IBP and techniques to help assure safe use. The Vueway IBP is to be used only in a room designated for performing radiological procedures that involve administration of a contrast agent. Utilize aseptic technique for penetrating the container closure of the IBP and transferring Vueway.
Penetrate the container closure only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set (e.g., transfer spike) approved or cleared for use with this IBP. During the entire period of use, ensure that the contents of the Vueway IBP container remain in continuous contact with the automated contrast injector system, contrast management system, or contrast media transfer set.
To ensure the protection of the contrast media against any possible contamination, do not remove the dispensing set from the IBP container closure. Once the Vueway IBP container is punctured, do not remove it from the work area. Store the Vueway IBP at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature].
Maximum use time from puncture is 24 hours. Discard any unused Vueway 24 hours after puncture of the IBP. After the container closure is punctured, if the integrity of the IBP and the delivery system cannot be assured through direct continuous supervision, the IBP and all associated disposables for the automated contrast injection system, contrast management system, or contrast media transfer set should be discarded.
If solidification occurs in the IBP due to cold exposure, bring the IBP of Vueway to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration.
Contraindications
Vueway is contraindicated in patients with history of hypersensitivity reactions to Vueway. History of hypersensitivity reactions to Vueway ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for gadopiclenol. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on Vueway use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. GBCAs cross the placenta and result in fetal exposure. In human placental imaging studies, contrast was visualized in the placenta and fetal tissues after maternal GBCA administration. Based on animal studies, use of GBCAs during pregnancy may result in fetal gadolinium retention. Published epidemiological studies on the association between GBCAs and adverse fetal outcomes have reported inconsistent findings and have important methodological limitations (see Data ) .
In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of Vueway during organogenesis (see Data ) . Because of the potential risks of gadolinium to the fetus, use Vueway only if imaging is essential during pregnancy and cannot be delayed. The 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 Available data regarding exposure to GBCAs during pregnancy from published epidemiological studies are not sufficient to assess the potential risk of adverse fetal and neonatal effects that may be associated with GBCAs. A retrospective cohort study of over 1.4 million pregnancies in Ontario, Canada, comparing pregnant women who had a GBCA MRI to pregnant women who did not have an MRI, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving GBCA MRI. Limitations of this study include a lack of comparison with non-contrast MRI and lack of information about the maternal indication for MRI.
Another retrospective cohort study of over 11 million pregnancies in the Medicaid database found no increased risk of fetal or neonatal death or Neonatal Intensive Care Unit admission when comparing pregnancies exposed to GBCA MRI versus non-contrast MRI. These two retrospective observational studies assessed a limited number of potential pregnancy outcomes and did not evaluate the full spectrum of potential fetal risk. Animal Data Gadolinium Retention GBCAs administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium…
Breastfeeding (LactMed)
Guidelines developed by several professional organizations state that breastfeeding need not be disrupted after a nursing mother receives a gadolinium-containing contrast medium.- However, because there is no published experience with gadopiclenol during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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