Multihance

What is Multihance?

Multihance is a prescription medicine called a gadolinium-based contrast agent (GBCA). Multihance, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner. An MRI exam with a GBCA, including Multihance, helps your doctor to see problems better than an MRI exam without a GBCA.

Description

MultiHance injection is supplied as a sterile, nonpyrogenic, clear, colorless to slightly yellow aqueous solution intended for intravenous use only. Each mL of MultiHance contains 529 mg gadobenate dimeglumine and water for injection. MultiHance contains no preservatives.

Gadobenate dimeglumine is chemically designated as (4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)- 1-phenyl-2-oxa-5,8,11-triazatridecan-13-oato(5-)] gadolinate(2-) dihydrogen compound with 1-deoxy-1-(methylamino)-D-glucitol (1:2) with a molecular weight of 1058.2 and an empirical formula of C22H28GdN3O11 • 2C7H17NO5. The structural formula is as follows:

MultiHance has a pH of 6.5-7.5. Pertinent physicochemical parameters are provided below:

MultiHance has an osmolality 6.9 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.

 Mechanism of Action

Gadobenate dimeglumine is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The large magnetic moment produced by the paramagnetic agent results in a large local magnetic field, which can enhance the relaxation rates of water protons in its vicinity leading to an increase of signal intensity (brightness) of tissue.

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

• Multihance 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 Multihance.

Who should not use Multihance?

Do not receive Multihance if you have had a severe allergic reaction to GBCAs including gadobenate dimeglumine, or any of the ingredients in Multihance.

What should I tell my healthcare provider before using Multihance?

Before receiving Multihance, 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 Multihance can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as Multihance is received during pregnancy
• have kidney problems, diabetes, or high blood pressure.
• have had an allergic reaction to dyes (contrast agents) including GBCAs

How should I use Multihance?

Multihance, like other GBCAs, is injected into your vein by a healthcare professional and used with a magnetic resonance imaging (MRI) scanner.

What are the possible side effects of Multihance?

• See “What is the most important information I should know about Multihance?”
• Allergic reactions. Multihance 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 Multihance include: nausea, headache, feeling hot, or burning at the injection site.

These are not all the possible side effects of Multihance.
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 Multihance

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

What are the ingredients in Multihance?

Active ingredient: gadobenate dimeglumine

Inactive ingredients: water

Label

PRINCIPAL DISPLAY PANEL

 

Multihance Multipack 50 mL
NDC 0270-5264-16

SRC: NLM .