Gadoquatrane
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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. AMBELVIST 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 AMBELVIST 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 (for example, age > 60 years, hypertension, or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
For patients at highest risk for NSF, do not exceed the recommended AMBELVIST 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. AMBELVIST 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 AMBELVIST 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 gadoquatrane 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 AMBELVIST among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.
No dose adjustment of AMBELVIST is recommended for patients with renal impairment. AMBELVIST can be removed from the body by hemodialysis [see Warnings and Precautions and Clinical Pharmacology ] .
Preparation and administration
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Administration and Imaging Instructions Administer AMBELVIST as an intravenous injection, manually or by compatible power injector, at a flow rate of approximately 1 mL/second to 4 mL/second, followed by a flush of 0.9% sodium chloride injection. For pediatric patients, adjust the flow rate and flush volume based on age.
AMBELVIST is for intravenous use only and must not be administered intrathecally [see Warnings and Precautions ]. Use aseptic technique when preparing and administering AMBELVIST. Visually inspect AMBELVIST for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, particulate matter is present, or the container appears damaged.
If solidification occurs due to cold exposure, bring AMBELVIST to room temperature before use and inspect to ensure that the solution is clear and colorless to pale yellow. Do not mix AMBELVIST with other medications, and do not administer AMBELVIST in the same intravenous line simultaneously with other medications because of the potential for chemical incompatibility.
Contrast MRI can begin immediately following the injection of AMBELVIST.
Directions for Use of Imaging Bulk Package AMBELVIST Imaging Bulk Package (IBP) is not for direct infusion. The IBP is for use only 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. See drug and device labeling for information on devices indicated for use with this IBP and techniques to help assure safe use.
The AMBELVIST IBP is to be used only in a room designated for radiological procedures that involve intravascular administration of a contrast agent. Utilize aseptic technique for penetrating the container closure of the AMBELVIST IBP and transferring AMBELVIST. 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 contrast agent in this IBP.
Once the AMBELVIST IBP is punctured, do not remove it from the work area during the entire period of use. Storage temperature of AMBELVIST IBP after the closure has been entered is 20°C to 25°C (68°F to 77°F). Maximum use time is 6 hours from puncture. Discard any unused portion 6 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 (e.g., transfer spike) should be discarded.
Directions for Use of Pharmacy Bulk Package AMBELVIST Pharmacy Bulk Package (PBP) is not for direct infusion. The PBP is for use with an appropriate transfer device for filling empty sterile syringes. Perform the transfer of AMBELVIST from the PBP in an aseptic work area, such as a laminar flow hood, using aseptic technique.
Penetrate the closure only one time. Once the PBP is punctured, do not remove it from the aseptic work area. Use each individual dose of AMBELVIST promptly following withdrawal from the PBP. Withdraw the contents of the PBP within 6 hours after puncture at 20°C to 25°C (68°F to 77°F). Discard any unused portion after 6 hours.
Contraindications
4 CONTRAINDICATIONS AMBELVIST is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST. History of severe hypersensitivity to AMBELVIST. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for gadoquatrane. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on AMBELVIST 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 gadoquatrane during organogenesis (see Data ) . Because of the potential risks of gadolinium to the fetus, use AMBELVIST only if imaging is essential during pregnancy and cannot be delayed. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, 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 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 Gd/kg on gestational days 85 and 135) result in measurable gadolinium…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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