Gadoxetate disodium

What is Gadoxetate disodium?

• Gadoxetate disodium (Eovist) is a gadolinium-based contrast agent used in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in patients with known or suspected focal liver disease.

Gadoxetate

What are the uses of this medicine?

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

How does this medicine work?

• Gadoxetate disodium is a paramagnetic compound and develops a magnetic moment when placed in a magnetic field.
• The relatively large magnetic moment produced by gadoxetate disodium results in a local magnetic field, yielding enhanced relaxation rates (shortening of relaxation times) of water protons in the vicinity of the paramagnetic agent, which leads to an increase in signal intensity (brightening) of blood and tissue.

In MRI, visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occur with:

* 1) differences in proton density 
*  2) differences of the spin-lattice or longitudinal relaxation times (T1); and  
* 3) differences in the spin-spin or transverse relaxation time (T2). 

• When placed in a magnetic field, gadoxetate disodium decreases the T1 and T2 relaxation time in target tissue.
• At the recommended dose, the effect is observed with greatest sensitivity in T1-weighted MR sequences.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• history of severe hypersensitivity reactions to EOVIST.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with EOVIST.

Is this medicine FDA approved?

• Initial U.S. Approval: 2008

How should this medicine be used?

Recommended dosage:

• The recommended dose of EOVIST is 0.1 mL/kg body weight (0.025 mmol/kg body weight).

Administration:

• Eovist, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.
• EOVIST is a ready-to-use solution for single use only.
• Visually inspect EOVIST for particulate matter and discoloration prior to administration.
• Do not use the solution if it is discolored or if particulate matter is present.
• The rubber stopper should not be pierced more than once. Use EOVIST immediately after opening.
• Unused portions should be discarded.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 181.43 mg/mL in single-dose containers (vials)

This medicine is available in fallowing brand namesː

• EOVIST

What side effects can this medication cause?

The most common side effects of this medicine include:

* nausea
* headache
* feeling hot
* dizziness
* back pain

What special precautions should I follow?

• Advise patients that gadolinium is retained for months or years in brain, bone, skin, and other organs in patients with normal renal function. The clinical consequences of retention are unknown. Retention depends on multiple factors and is greater following administration of linear GBCAs than following administration of macrocyclic GBCAs.
• Nephrogenic Systemic Fibrosis has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeated dosing appears to increase the risk.
• Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory and cutaneous manifestations, ranging from mild to severe, including shock have uncommonly occurred following EOVIST administration. Monitor patients closely for need of emergency cardiorespiratory support.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• The maximum dose studied in MR imaging was 0.4 mL/kg (0.1 mmol/kg) body weight and was tolerated in a manner similar to lower doses.

Management of overdosage:

• In case of inadvertent overdosage in patients with severely impaired renal and/or hepatic function, EOVIST can be partially removed by hemodialysis.

Can this medicine be used in pregnancy?

• GBCAs have been shown to cross the human placenta and result in fetal exposure and gadolinium retention.
• Because of the potential risks of gadolinium to the fetus, use EOVIST only if imaging is essential during pregnancy and cannot be delayed.
• It is not known if Eovist can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as Eovist is received during pregnancy.

Can this medicine be used in children?

• Adequate and well-controlled studies of EOVIST in pediatric patients have not been conducted.
• No dose adjustment according to age is necessary in pediatric patients.
• The safety and effectiveness of EOVIST have not been established in premature infants.

What are the active and inactive ingredients in this medicine?

• Active ingredient: gadoxetate disodium
• Inactive ingredients: caloxetate trisodium, trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment), and water for injection.

Who manufactures and distributes this medicine?

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ

• Manufactured in Germany

What should I know about storage and disposal of this medication?

• Store at temperatures between 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59 to 86).
• Use EOVIST immediately after opening.
• Unused portions should be discarded.

• Dailymed label info on Gadoxetate disodium
• FDA Gadoxetate disodium

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