Gadopentetate

Gadopentetate is a contrast agent used in combination with magnetic resonance imaging (MRI) to xfacilitate the visualization of lesions and abnormal vascularity in the brain, spine and associated tissues, head, neck, and body.

• Gadopentetate is available under the following different brand names: Magnevist

Common side effects of Gadopentetate include:

• headache
• dizziness
• anxiety
• nausea
• vomiting
• loss of appetite
• increased thirst
• chills
• numbness or tingly feeling
• injection site reactions (cold feeling, warmth, pain, or burning)
• stuffy nose
• sore throat
• feeling unusually hot
• unusual or unpleasant taste in the mouth
• flushing (warmth, redness, or tingly feeling)

Serious side effects of Gadopentetate include:

• hives 
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• urinating less than usual or not at all
• drowsiness
• confusion
• mood changes
• increased thirst and loss of appetite
• weight gain
• feeling short of breath
• swelling, bruising, redness, itching, burning, or skin changes where the injection was given

Rare side effects of Gadopentetate include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 469.01 mg/mL

MRI contrast agent

Adult dosage

• 0.2 mL/kg IV bolus; not to exceed infusion rate of 10 mL/15 sec
• Dosing in patients more than 286 pounds not studied

Pediatric dosage

• Children younger than 2 years: Safety and efficacy not established
• Children aged 2 years and older: as adults; 0.2 mL/kg IV bolus; not to exceed infusion rate of 10 mL/15 sec

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Gadopentetate has no noted severe interactions with any other drugs
• Gadopentetate has no noted serious interactions with any other drugs
• Gadopentetate has no noted moderate interactions with any other drugs
• Gadopentetate has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of severe hypersensitivity reactions

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Gadopentetate?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Gadopentetate?"

Cautions

• Screen all patients for renal dysfunction
• Thrombotic syndromes, anemia, hepatic/renal impairment, hemoglobinopathies (sickle cell anemia)
• Risk for nephrogenic systemic fibrosis in patients with acute or chronic severe renal insufficiency, hepatorenal syndrome, or in perioperative liver transplantation period
• Risk for hypotension
• The 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
  • The 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 a higher risk for gadolinium retention
• Brain deposits
  • The FDA investigated the risk for brain deposits following repeated use of gadolinium-based contrast agents (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 greater than four 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

Pregnancy and Lactation

• 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
• The estimated background risk for 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 two 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 for birth defect, loss, or other adverse outcomes
• Male infertility
  • Intravenous injections of gadopentetate dimeglumine (16-18 doses over 23-25 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 the underlying maternal condition.