Eovist

Gadoxetate can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:

• burning, itching, swelling, scaling, and tightening or hardening of your skin;

• muscle weakness;

• joint stiffness in your arms, hands, legs, or feet;

• deep bone pain in your ribs or your hips;

• trouble moving; or

• skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive an MRI with gadoxetate. Also tell your doctor if you have recently received any contrast agents similar to gadoxetate.

To make sure you can safely receive this medication, tell your doctor if you have any of these other conditions:

• diabetes;

• high blood pressure;

• liver disease (or liver transplant);

• a heart rhythm disorder;

• a personal or family history of Long QT Syndrome;

• anemia or other red blood cell disorder;

• asthma, hay fever, or a history of food or drug allergies;

• if you are over 60 years old;

• if you have ever had a reaction to a contrast agent; or

• if you have recently had an injury, surgery, or severe infection.

FDA pregnancy category C. It is not known whether gadoxetate will harm an unborn baby. Before you receive this medication, tell your doctor if you are pregnant.

It is not known whether gadoxetate passes into breast milk or if it could harm a nursing baby. You should not breast-feed for at least 10 hours after receiving gadoxetate. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Since gadoxetate is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor if you are also taking rifampin (Rifadin, Rifater, Rifamate).

Gadoxetate can harm the kidneys in certain people, and this effect may be increased if you also use other medicines harmful to the kidneys. Before you receive gadoxetate, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

There may be other drugs that can affect gadoxetate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Gadoxetate is a magnetic resonance imaging (MRI) contrast agent. Contrast agents are used to help create a clear picture of the body during MRI scans. MRI scans are a special kind of diagnostic procedure. They use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve ionizing radiation. Gadoxetate is a gadolinium-based contrast agent (GBCA).

Gadoxetate is given by injection before MRI to help diagnose problems in the liver.

This medicine is to be used only by or under the direct supervision of a doctor.

• It is used during an MRI (magnetic resonance imaging) test.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity studies of Eovist have been conducted.

Gadoxetate disodium was not mutagenic in in vitro reverse mutation tests in bacteria, or in chromosome aberration tests in human peripheral blood lymphocytes, and was negative in an in vivo micronucleus test in mice after intravenous injection of doses up to 4 mmol/kg.

Gadoxetate disodium had no effect on fertility and general reproductive performance of male and female rats when given in doses 6.5 times the human dose (based on body surface area).

Animal Toxicology and/or Pharmacology

A dose-related increase in QTc which was resolved by 30 minutes post dosing was observed in dogs when given a single dose of Eovist. The increase was noted when given in doses equal to or greater than 0.1 mmol/kg (2.2 times the human dose). Maximum increase in QTcF was equal to or less than 20 ms at doses up to 0.5 mmol/kg (11 times the human dose).

A gait disturbance was observed in 1 of 3 mice when givenEovist at a dose of approximately 1.1 mmol/kg (3.6 times the human dose); the disturbance occurred at 30 minutes post dosing and resolved at 4 hours post dosing.

Local intolerance reactions, including moderate interstitial hemorrhage, edema, and focal muscle fiber necrosis, were observed after intramuscular administration of Eovist[see Warning and Precautions (5.4)].

NDC 50419-320-05
5 vials of 10 mL
sterile solution
Eovist® 10 mL
(gadoxetate disodium)
Injection
0.25 mol/L
Rx only
Each mL contains 181.43 gadoxetate disodium and the excipients caloxetate trisodium, trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment), and water for injection. Eovist® contains no antimicrobial preservative.
Single-dose container.
Discard unused portion.
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C [See USP Controlled Room Temperature.]
For intravenous administration.
Dosage: See package insert.
Mfd. for:
Bayer HealthCare Pharmaceuticals Inc.
Wayne, NJ 07470
Mfd. in Germany

Tell your doctor if you are also taking rifampin (Rifadin, Rifater, Rifamate).

Eovist can harm the kidneys in certain people, and this effect may be increased if you also use other medicines harmful to the kidneys. Before you receive Eovist, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

There may be other drugs that can affect Eovist. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Applies to gadoxetate disodium: intravenous solution

Cardiovascular

Cardiovascular side effects have included chest pain, bundle branch block, increased blood pressure, and flushing.[Ref]

Nervous system

Nervous system side effects have included headache, akathisia, dizziness, parosmia, vertigo, tremor, akathisia, and dysgeusia.[Ref]

Respiratory

Respiratory side effects have included dyspnea and respiratory distress.[Ref]

Gastrointestinal

Gastrointestinal side effects have included dry mouth, oral discomfort, salivary hypersecretion, nausea, and vomiting.[Ref]

General

General side effects have included feeling hot, chills, discomfort, fatigue and malaise.[Ref]

Dermatologic

Dermatologic side effects have included maculopapular rash, hyperhidrosis, rash, and pruritus.[Ref]

Local

Local side effects have included injection site reactions (pain, burning, coldness, extravasation).[Ref]

Some side effects of Eovist may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.