ProHance (gadoteridol) for MRI: Side Effects & Warnings

Generic drug: gadoteridol

Brand name: ProHance

What is ProHance (gadoteridol), and how does it work?

• ProHance (gadoteridol) is a prescription medicine called a gadolinium-based contrast agent (GBCA). ProHance, like other GBCAs, is used with a magnetic resonance imaging (MRI) scanner.
• An MRI exam with a GBCA, including ProHance, helps your doctor to see problems better than an MRI exam without a GBCA.
• Your doctor has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam.

What are the side effects of ProHance?

WARNING

NEPHROGENIC SYSTEMIC FIBROSIS

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs 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 <30 mL/min/1.73m²), 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 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.

Possible side effects of ProHance include:

• Allergic reactions.
  ProHance can cause allergic reactions that can sometimes be serious. Your
  healthcare provider will monitor you closely for symptoms of an allergic
  reaction.

The most common side effects of ProHance include:

• nausea,
• taste perversion,
• headache,
• feeling hot, or
• burning at the injection site.

These are not all the possible side effects of ProHance.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for ProHance?

Dosing And Imaging Instructions

MRI Of The CNS

Adults

• Recommended dose is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min)
• A supplementary dose of 0.2 mmol/kg (0.4 mL/kg) may be given up to 30 minutes after the first dose in patients with normal renal function suspected of having poorly enhancing lesions, in the presence of negative or equivocal scans
• Immediately after injection, inject at least a 5 mL normal saline flush to ensure complete administration of contrast medium
• Imaging procedure should be completed within 1 hour of the first injection of ProHance

Pediatric Use (2-17 years)

• Recommended dose is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min)
• Safety and efficacy of doses > 0.1 mmol/kg, and sequential and/or repeat procedures have not been studied
• Follow injection by at least a 5 mL normal saline flush

MRI Of Extracranial/Extraspinal Tissues

Adults

• Recommended dose 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min)
• To ensure complete injection of the contrast medium, the injection should be followed by at least a 5 mL normal saline flush

Pediatric Use

• Safety and efficacy for extracranial/extraspinal tissues have not been established.

What drugs interact with ProHance?

No human drug interaction studies have been performed.

Is ProHance safe to use while pregnant or breastfeeding?

• 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.
• Because of the potential risks of gadolinium to the fetus, use ProHance only if imaging is essential during pregnancy and cannot be delayed.
• Contrast enhancement is visualized in the human 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.
•  Overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of GBCAs in pregnancy.
• It is not known whether this drug is excreted in human milk.
• Because many drugs are excreted in human milk, caution should be exercised when ProHance is administered to a nursing woman.