Gadoteridol
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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. ProHance 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 ProHance 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 systemic fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: chronic, severe kidney disease (GFR less than 30 mL/min/1.73m 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 greater than 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 ProHance dose and allow a sufficient period of time for elimination of the drug from the body prior to 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. ProHance 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 ProHance 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 systemic fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: chronic, severe kidney disease (GFR less than 30 mL/min/1.73m 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 greater than 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing ( 5.2 ).
Paramagnetic Contrast Agent
Dosing in kidney impairment
Renal Impairment No ProHance dosage adjustment is recommended for patients with renal impairment. Gadoteridol can be removed from the body by hemodialysis [see Warning and Precautions and Clinical Pharmacology] .
Preparation and administration
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Administration Visually inspect ProHance for particulate matter and discoloration prior to use Do not administer the solution if it is discolored or particulate matter is present Concurrent medications or parenteral nutrition should not be physically mixed with contrast agents and should not be administered in the same intravenous line because of the potential for chemical incompatibility Inject at least a 5 mL normal saline flush immediately after ProHance injection to ensure complete administration Imaging procedures should be completed within 1 hour
Directions for Proper Use of Pharmacy Bulk Package NOT FOR DIRECT INFUSION The pharmacy bulk package is used as a multiple dose container with an appropriate transfer device to fill empty sterile syringes. Use the following procedures when transferring ProHance from the pharmacy bulk package to individual syringes: Use of this product is restricted to a suitable work area, such as a laminar flow hood, utilizing aseptic technique Prior to entering the vial, remove the seal and cleanse the rubber closure with a suitable antiseptic agent The container closure may be penetrated only one time, utilizing a suitable transfer device or dispensing set that allows measured dispensing of the contents Once the pharmacy bulk package is punctured, it should not be removed from the aseptic work area during the entire period of use Withdrawal of container contents should be accomplished without delay.
A maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operations Any unused contents must be discarded by 8 hours after initial puncture of the bulk package Once drawn into syringe, administer transferred agent promptly for single-dose administration
| Table 1: Recommended Volume of ProHance Injection by Body Weight | |
| Body Weight (kg) | Volume to be Administered (mL) |
| 2.5 | 0.5 |
| 5 | 1 |
| 10 | 2 |
| 20 | 4 |
| 30 | 6 |
| 40 | 8 |
| 50 | 10 |
| 60 | 12 |
| 70 | 14 |
| 80 | 16 |
| 90 | 18 |
| 100 | 20 |
| 110 | 22 |
| 120 | 24 |
| 130 | 26 |
| 140 | 28 |
| 150 | 30 |
Contraindications
ProHance is contraindicated in patients with known allergic or hypersensitivity reactions to ProHance [see Warnings and Precautions ( 5.3 )]. Allergic or hypersensitivity reactions to ProHance ( 4 ).
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for gadoteridol. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary GBCAs cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data) . Because of the potential risks of gadolinium to the fetus, use ProHance only if imaging is essential during pregnancy and cannot be delayed. In animal reproduction studies in rats, gadoteridol doubled the incidence of post-implantation loss at up to 16 times the recommended human dose (RHD).
There were no adverse developmental effects observed in rabbits with intravenous administration of gadoteridol during organogenesis at doses up to 19 times the recommended human dose of 0.1 mmol/kg (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is 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 is 15 to 20%, respectively.
Data Human Data Contrast agent is visualized in the placenta and fetal tissues after maternal GBCA administration. Cohort studies and case reports on exposure to GBCAs during pregnancy have not reported a clear association between GBCAs and adverse effects in the exposed neonates. However, a retrospective cohort study, 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.
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 concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. GBCAs administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one-month postnatal age.
Reproductive Toxicology Gadoteridol was administered in intravenous doses of 0, 0.375, 1.5, 6.0, and 10 mmol/kg/day [0.6, 2.4, 9.7, and 16 times the recommended human dose (RHD) based on body surface area (BSA)] to female rats from gestational day (GD)6 until GD17. Gadoteridol at 10 mmol/kg/day for 12 days during gestation doubled the incidence of…
Breastfeeding (LactMed)
Although no data exist on the excretion of gadoteridol into milk, only 0.01 to 0.04% of the maternal gadolinium dose is present in breastmilk and there is limited gastrointestinal absorption in the breast-fed infant with other gadolinium contrast agents. Gadoteridol is one of the most stable gadolinium agents, theoretically making it one of the safer drugs to use during breastfeeding. Guidelines developed by several professional organizations state that breastfeeding need not be disrupted after a nursing mother receives a gadolinium-containing contrast medium.-
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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