Gadoteridol

Name: Gadoteridol

Warnings

Black Box Warnings

Risk for nephrogenic systemic fibrosis (NSF) with acute or chronic renal insufficiency (GFR <30 mL/min/1.73 sq.m, hepatorenal syndrome, or acute renal insufficiency resulting from perioperative liver transplant

NSF affects internal organs, skin, and muscle and can be fatal

Only use if essential and MRI cannot not provide appropriate diagnostic image

Screen for renal dysfunction, do not exceed recommended dosage, and allow for drug elimination before giving subsequent doses

Contraindications

Hypersensitivity

Cautions

Caution in hyperthyroidism, pheochromocytoma, renal/hepatic impairment

Therapy in patients with sickle cell anemia not studied

Screen patients for kidney disease before use and monitor renal function afterward; nephrogenic systemic fibrosis (NSF) associated with use of gadolinium contrast media in patients with kidney disease; do not exceed recommended dose

Brain deposits

  • 7/28/2015: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for MRI
  • Recent 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
  • It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects
  • 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

Gadoteridol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;

  • drowsiness, confusion, mood changes, increased thirst, loss of appetite;

  • swelling, weight gain, feeling short of breath;

  • fast, uneven heart rate;

  • seizure (convulsions); or

  • feeling like you might pass out.

Less serious side effects may include:

  • nausea;

  • mild itching;

  • unusual or unpleasant taste in your mouth;

  • flushing (warmth, redness, or tingly feeling);

  • headache, dizziness;

  • numbness, burning pain, or tingling in your hands or feet; or

  • cold feeling, warmth, pain, bruising, swelling, or burning where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What do I need to tell my doctor BEFORE I take Gadoteridol?

  • If you have an allergy to gadoteridol or any other part of gadoteridol.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Usual Adult Dose for CNS Magnetic Resonance Imaging

Central Nervous System:
0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min to 60 mL/min) or bolus (greater than 60 mL/min). In patients suspected of having poorly enhancing lesions, in the presence of negative or equivocal scans, a second dose of 0.2 mmol/kg (0.4 mL/kg) may be given up to 30 minutes after the first dose.

Extracranial and Extraspinal Tissues:
0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min to 60 mL/min) or bolus (greater than 60 mL/min).

Liver Dose Adjustments

Data not available

Dialysis

Data not available

Gadoteridol Breastfeeding Warnings

There are no data on the excretion of gadoteridol into human milk. The manufacturer recommends that caution be used when administering gadoteridol to nursing women.

Administrative Information

LactMed Record Number

533

Last Revision Date

20170127

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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