Gadavist (Page 10 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Gadavist is a sterile, clear and colorless to pale yellow solution containing 604.72 mg gadobutrol per mL (equivalent to 1 mmol gadobutrol) per mL. Gadavist is supplied in the following sizes:

30 mL Pharmacy Bulk Package, rubber stoppered in cartons of 5, Boxes of 10
(NDC 50419-325-14)

65 mL Pharmacy Bulk Package, rubber stoppered, Boxes of 10
(NDC 50419-325-15)

16.2 Storage and Handling

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

Should freezing occur, Gadavist should be brought to room temperature before use. If allowed to stand at room temperature, Gadavist should return to a clear and colorless to pale yellow solution. Visually inspect Gadavist for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, if particulate matter is present or if the container appears damaged.

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, or
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 manifestation 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 Gadavist 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 Gadavist 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.

© 2011, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc.Whippany, NJ 07981

Manufactured in Germany

Medication Guide

GADAVIST (gad-a-vist)

(gadobutrol) Injection for intravenous use

What is Gadavist?

Gadavist is a prescription medicine called a gadolinium-based contrast agent (GBCA). Gadavist, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.
An MRI exam with a GBCA, including Gadavist, 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.

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

Gadavist 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 Gadavist.

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

Before receiving Gadavist, 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 Gadavist can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as Gadavist 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 Gadavist?

See “What is the most important information I should know about Gadavist?”
Allergic reactions. Gadavist 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 Gadavist include: headache, nausea, and dizziness.

These are not all the possible side effects of Gadavist.

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 Gadavist.

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

What are the ingredients in Gadavist?

Active ingredient: gadobutrol

Inactive ingredients: calcobutrol sodium, trometamol, hydrochloric acid (for pH adjustment) and water for injection

Manufactured for Bayer HealthCare Pharmaceuticals Inc.

Manufactured in Germany

© 2011, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

For more information, go to www.gadavist.com or call 1-888-842-2937.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. 4/2018

The following is a representative example of Gadavist labeling. See the “How Supplied” section for a complete listing of all components.

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