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ProHance Injection 279.3 mg/mL NDA020131: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
279.3 mg/mL
Drug class:
The same patient information also applies to:
  • ProHance Injection 279.3 mg/mL NDA021489
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - ProHance Injection 279.3 mg/mL NDA020131

What is the most important information I should know about PROHANCE?

  • GBCAs like PROHANCE may cause serious side effects including death, coma, encephalopathy, and seizures when it is given intrathecally (injection given into the spinal canal). It is not known if PROHANCE is safe and effective with intrathecal use. PROHANCE is not approved for this use.
  • PROHANCE contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years).
  • It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys.
  • Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium.
  • There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist, or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance.
  • People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body.
  • Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive PROHANCE.

What is PROHANCE?

  • PROHANCE 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.

Do not receive PROHANCE if you have had a severe allergic reaction to PROHANCE.

Before receiving PROHANCE, tell your healthcare provider about all your medical conditions, including if you:

  • have had any MRI procedures in the past where you received a GBCA. Your healthcare provider may ask you for more information including the dates of these MRI procedures.

  • are pregnant or plan to become pregnant. It is not known if PROHANCE can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as PROHANCE is received during pregnancy

  • have kidney problems, diabetes, or high blood pressure
  • have had an allergic reaction to dyes (contrast agents) including GBCAs

What are the possible side effects of PROHANCE?

  • See “What is the most important information I should know about PROHANCE?”
  • 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, distortion of the sense of taste, and headache.

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.

General information about the safe and effective use of PROHANCE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about PROHANCE that is written for health professionals.

What are the ingredients in PROHANCE?

Active ingredient: gadoteridol

Inactive ingredients: calteridol calcium, tromethamine

Manufactured by: BIPSO GmbH-78224 Singen (Germany)

Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08540

For more information, go to www.imaging.bracco.com or call 1-800-257-5181.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 020131 · View the label on DailyMed

Revision date stated in the text: March 2025

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Drug information for ProHance Injection 279.3 mg/mL NDA020131

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Paramagnetic Contrast Agent
Active ingredient Gadoteridol 279.3 mg/mL
Dosage form Injection, solution
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) BRACCO
FDA approval NDA 020131New Drug Application (NDA) Approved November 16, 1992
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
279.3 mg/mL – 5 ml in 1 vial, single-dose / 5 in 1 box NDC 0270-1111-04
279.3 mg/mL – 10 ml in 1 vial, single-dose / 5 in 1 box NDC 0270-1111-01
279.3 mg/mL – 15 ml in 1 vial, single-dose / 5 in 1 box NDC 0270-1111-02
279.3 mg/mL – 20 ml in 1 vial, single-dose / 5 in 1 box NDC 0270-1111-03

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.