EOVIST (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

EOVIST is supplied in single-dose, rubber stoppered containers (vials) containing 181.43 mg/mL of gadoxetate disodium (equivalent to 0.25 mmol/mL gadoxetate disodium), in the following sizes:

10 mL single-dose containers (vials) filled with 10 mL, boxes of 5 (NDC 50419-320-05)

16.2 Storage and Handling

Store at temperatures between 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59 to 86) [see USP Controlled Room Temperature].

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.

17 PATIENT COUNSELING INFORMATION

•

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Nephrogenic Systemic Fibrosis

Instruct patients to inform their physician if they:

•

Have a history of kidney disease and/or liver disease

•

Have recently received a GBCA

GBCAs increase the risk of NSF among patients with impaired elimination of drugs. To counsel patients at risk of NSF:

•

Describe the clinical manifestations of NSF

•

Describe procedures to screen for the detection of renal impairment

Instruct the patients to contact their physician if they develop signs or symptoms of NSF following EOVIST administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.

Common Adverse Reactions

Inform patients that they may experience:

•

Reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site

•

Side effects of headache, nausea, abnormal taste and feeling hot

General Precautions

Gadolinium Retention

•

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 [see Warnings and Precautions (5.3)].

Instruct patients receiving EOVIST to inform their physician if they:

•

Are pregnant or breastfeeding

•

Have a history of allergic reaction to contrast media, bronchial asthma or allergic respiratory disorder

© 2008, Bayer HealthCare Pharmaceuticals Inc., All rights reserved.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc.Whippany, NJ 07981

Manufactured in Germany

Medication Guide

EOVIST (e-o-vist) (gadoxetate disodium) Injection for intravenous use

What is Eovist? • 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.

What is the most important information I should know about Eovist? • Eovist 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. • At equivalent doses, 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 Eovist.

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

Before receiving Eovist, 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 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. • 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 Eovist? • See “What is the most important information I should know about Eovist?” • Allergic reactions. Eovist 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 Eovist include: nausea, headache, feeling hot, dizziness, and back pain. These are not all the possible side effects of Eovist. 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 EOVIST. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about EOVIST that is written for health professionals.

What are the ingredients in Eovist? Active ingredient: gadoxetate disodium Inactive ingredients: caloxetate trisodium, trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment), and water for injection. Manufactured for Bayer HealthCare Pharmaceuticals Inc. Manufactured in Germany © 2008 Bayer HealthCare Pharmaceuticals Inc. All rights reserved. For more information, go to www.eovist.com or call 1-888-842-2937.

Carton 5 x 10 mL

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

EOVIST gadoxetate disodium injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-320 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GADOXETATE DISODIUM (GADOLINIUM CATION (3+)) GADOXETATE DISODIUM 181.43 mg in 1 mL

Inactive Ingredients Ingredient Name Strength TROMETHAMINE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50419-320-05 5 VIAL, SINGLE-DOSE in 1 BOX contains a VIAL, SINGLE-DOSE 1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BOX (50419-320-05) 2 NDC:50419-320-15 5 VIAL, SINGLE-DOSE in 1 BOX contains a VIAL, SINGLE-DOSE 2 15 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BOX (50419-320-15) 3 NDC:50419-320-75 5 VIAL, SINGLE-DOSE in 1 BOX contains a VIAL, SINGLE-DOSE 3 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BOX (50419-320-75)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022090 07/03/2008

Labeler — Bayer HealthCare Pharmaceuticals Inc. (005436809)

Establishment
Name	Address	ID/FEI	Operations
Bayer AG		315097875	MANUFACTURE (50419-320)

Establishment
Name	Address	ID/FEI	Operations
QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC		080629831	RELABEL (50419-320)

Revised: 12/2021 Bayer HealthCare Pharmaceuticals Inc.