Gadoterate
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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. DOTAREM 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 DOTAREM 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 ( 5.1 ).
For patients at highest risk for NSF, do not exceed the recommended DOTAREM 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. DOTAREM 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 DOTAREM 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 No DOTAREM dosage adjustment is recommended for patients with renal impairment. Gadoterate can be removed from the body by hemodialysis [ see Warnings and Precautions and Clinical Pharmacology ].
Preparation and administration
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Drug Handling Visually inspect DOTAREM for particulate matter prior to administration. Do not use the solution if particulate matter is present or if the container appears damaged. DOTAREM should be a clear, colorless to yellow solution. Do not mix with other drugs or parenteral nutrition. Discard any unused portions of the drug.
Directions for Use of the DOTAREM (gadoterate meglumine) Injection Glass vial: Aseptically draw up the contrast medium into a disposable syringe and use immediately. Glass or plastic pre-filled syringe: 1) Holding the syringe barrel firmly, screw the threaded tip of the plunger rod clockwise into the cartridge plunger. For glass pre-filled syringe : Push forward a few millimeters to break any friction between the cartridge plunger and syringe barrel.
For plastic pre-filled syringe : After screwing the push rod into the syringe cartridge plunger, turn the push rod clockwise an additional ½ turn so that the cartridge plunger rotates freely. 2) Holding the syringe vertically so the rubber cap is pointed upward, aseptically remove the rubber cap from the tip of the syringe and attach either a sterile, disposable needle or compatible needleless luer lock tubing set using a push-twist action.
At this point, the tubing set is not attached to a patient’s intravenous connection. If using a needleless luer lock tubing set, check the connection between the syringe and the tubing as the fluid flows. Ensure that the connection is successful before administration of DOTAREM Injection. If using a needle, hold the syringe vertically and push plunger forward until all of the air is evacuated and fluid either appears at the tip of the needle or the tubing is filled.
Following the usual venous blood aspiration procedure, complete the DOTAREM injection. 3) To ensure complete delivery of the contrast medium, the injection may be followed by a normal saline flush. 4) Properly dispose of the syringe and any other materials used. syringe
| Body Weight | Volume | |
| Pounds (lb) | Kilograms (kg) | Milliliters (mL) |
| 5.5 | 2.5 | 0.5 |
| 11 | 5 | 1 |
| 22 | 10 | 2 |
| 44 | 20 | 4 |
| 66 | 30 | 6 |
| 88 | 40 | 8 |
| 110 | 50 | 10 |
| 132 | 60 | 12 |
| 154 | 70 | 14 |
| 176 | 80 | 16 |
| 198 | 90 | 18 |
| 220 | 100 | 20 |
| 242 | 110 | 22 |
| 264 | 120 | 24 |
| 286 | 130 | 26 |
| 308 | 140 | 28 |
| 330 | 150 | 30 |
Drug interactions
Check gadoterate against a medication listLabel text (1 paragraph)
Gadoterate does not interfere with serum and plasma calcium measurements determined by colorimetric assays. Specific drug interaction studies with DOTAREM have not been conducted.
Contraindications
History of clinically important hypersensitivity reactions to DOTAREM [see Warnings and Precautions ( 5.2 )] . Clinically important hypersensitivity reactions to DOTAREM.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary GBCAs cross the human 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) . In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadoterate meglumine during organogenesis at doses up to 16 and 10 times, respectively, the recommended human dose (see Data) . Because of the potential risks of gadolinium to the fetus, use DOTAREM only if imaging is essential during pregnancy and cannot be delayed.
The estimated 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 2-4% and 15-20% respectively. Data Human Data Contrast enhancement 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 material indication for MRI. Overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of GBCAs in pregnancy.
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 Gadoterate meglumine was administered in intravenous doses of 0, 2, 4 and 10 mmol/kg/day [3, 7 and 16 times the recommended human dose (RHD) based on body surface area (BSA)) to female rats for 14 days before mating, throughout the mating period and until gestation day (GD) 17.…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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