gadopentetate (Rx)

Brand and Other Names:Magnevist
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 469.01mg/mL

MRI Contrast Agent

Indicated to facilitate the visulaization of lesions and abnormal vascularity in brain, spine and associated tissues, head, neck, and body

0.2 mL/kg IV bolus; not to exceed infusion rate of 10 mL/15 seconds

Dosing in patients > 286 pounds not studied

Dosage Forms & Strengths

injectable solution

  • 469.01mg/mL

MRI Contrast Agent

Indicated to facilitate the visulaization of lesions and abnormal vascularity in brain, spine and associated tissues, head, neck, and body

<2 years: Safety and efficacy not established

≥2 years: As adults; 0.2 mL/kg IV bolus; not to exceed infusion rate of 10 mL/15 seconds

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Warnings

Black Box Warnings

Nephrogenic systemic fibrosis

  • Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs
  • Avoid use of GBCAs in these patients unless diagnostic information is essential and not available with noncontrasted MRI or other modalities
  • NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs
  • Highest risk for NSF is among patients with chronic, severe kidney disease (GFR <30 mL/min/1.73²) 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, 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 recommended dose and allow a sufficient period of time for elimination of the drug from the body prior to readministration

Contraindications

History of severe hypersensitivity reactions

Cautions

Screen all patients for renal dysfunction

Thrombotic syndromes, anemia, hepatic/renal impairment, hemoglobinopathies (sickle cell anemia)

Risk for nephrogenic systemic fibrosis (NSF) in patients w/acute or chronic severe renal insufficiency, hepatorenal syndrome or in perioperative liver transplantation period (see Black Box Warnings)

Risk of hypotension

Site of injection may develop thrombosis

History of grand mal seizure

Safety of repeat doses not studied

Gadolinium retention

  • Gadolinium is retained for months or years in several organs
  • Highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (eg, brain, skin, kidney, liver, and spleen)
  • Duration of retention also varies by tissue and is longest in bone
  • Patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions are at higher risk of gadolinium retention
  • Brain deposits
    • FDA investigated the risk of brain deposits following repeated use of GBCAs for MRI in 2015
    • Publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo ≥4 contrast MRI scans, long after the last administration
    • As of 2017, the FDA review had not identified adverse health effects from gadolinium retained in the brain after the use of GBCAs MRI; all GBCAs may be associated with some gadolinium retention in the brain and other body tissues
    • Early data in rat studies show that linear GBCAs are more prone to dissociation into free gadolinium and demonstrate greater brain deposition than macrocyclic GBCAs, which are less prone to dissociation
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Pregnancy & Lactation

Pregnancy

GBCAs cross the placenta and result in fetal exposure and gadolinium retention

Human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive

Estimated background risk of major birth defects and miscarriage for the indicated population is unknown

In animal reproduction studies, repeated intravenous dosing of gadopentetate dimeglumine during organogenesis resulted in delayed fetal development in pregnant rats and rabbits at a dose 2 times and 2.4 times, respectively, the recommended human dose (based on body surface area [BSA]); no teratogenic effects were observed in rats or rabbits at doses or 7.3 times (rats) and 9.7 times (rabbits) the recommended human dose, based on BSA; because of potential risks of gadolinium to fetus, use therapy only if imaging is essential during pregnancy and cannot be delayed

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes

Male infertility

  • Intravenous injections of gadopentetate dimeglumine (16 to 18 doses over 23 to 25 days) caused spermatogenic cell atrophy and degeneration that was irreversible in male rats at a dose of 8 times (based on BSA) the recommended human dose

Lactation

Estimated infant exposure is 0.001%-0.04% of the maternal dose

Unknown whether the effects of the drug on the breastfed infant or the effects of the drug on milk production

Developmental and health benefits of breastfeeding should be considered together with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Paramagnetic agent; exposure to external magnetic field in gadopentetate may induce a large magnetic field. The local magnetism may change proton density and spin characteristics, which it is then detected by the imaging device

Pharmacokinetics

Excretion: urine (90-100%)

Dialyzable: yes

Vd: 266 mL/kg; does not cross intact brain barrier

Half-life: 1.6 hr

Excretion: Urine (91%)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.