CORRECTING and REPLACING FDA Approves Gadavist® (gadobutrol) Imaging Bulk Package

INDIANOLA, Pa.–(BUSINESS WIRE)–Please replace the release with the following corrected version due to multiple revisions.

The updated release reads:

FDA APPROVES GADAVIST^® (GADOBUTROL) IMAGING BULK PACKAGE

The first and only FDA-approved gadolinium-based contrast agent for multi-patient dosing with an FDA-cleared Transfer Spike in the MR suite.

The FDA announced the approval of the Gadavist^® (gadobutrol) Imaging Bulk Package. The Gadavist^® Imaging Bulk Package will be available in two presentation sizes, 30 mL and 65 mL_, and allows for weight-based dosing with a 24-hour stand time for multi-patient dosing.

In conjunction with the bulk package approval, the FDA also cleared the MEDRAD^® Imaging Bulk Package Transfer Spike that is indicated for the transfer of Gadavist^® contrast media as supplied in the Imaging Bulk Package presentation.

As the only MR contrast media FDA-approved Imaging Bulk Package for use with a cleared transfer spike, Gadavist^® Imaging Bulk Package offers key features to support the radiology workflow. After initial set up, the product can be used across multiple patients and work shifts for up to 24 hours after the first puncture of the Imaging Bulk Package. Compared to single-use bottles, the Imaging Bulk Package can potentially mean more complete usage of the contrast and less contrast and vial waste. In addition, technologists and nurses can prepare and administer weight-based dosing using a single multi-dose set up directly in the scan room. The bulk package adheres to the Joint Commission requirements for multi-patient dosing.¹

“With the changing healthcare environment, Bayer is dedicated to investing not only in new innovations, but aligning our solutions to address some of the challenges that hospitals are facing today,” said Dennis Durmis, Head of Region Americas, Bayer Radiology. “We are focused on offering solutions in new areas of unmet need.”

¹ Sentinel Event Alert 52: Preventing infection from the misuse of vials. The Joint Comission web site. https://www.jointcommission.org/en/resources/patient-safety-topics/sentinel-event/sentinel-event-alert-newsletters/sentinel-event-alert-issue-52-preventing-infection-from-the-misuse-of-vials/. Accessed August 11, 2020.

About Gadavist

Gadavist^® (gadobutrol) injection was first approved in the U.S. in 2011 for intravenous use in magnetic resonance (MR) imaging in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Gadavist was further approved in the U.S. in 2014 for MR of the breast in adult patients to assess the presence and extent of malignant breast disease and for pediatric patients less than 2 years of age, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. In 2016, it was approved in the U.S. for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates. In 2019, it was approved in the U.S. for use to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

Gadavist, also known as Gadovist^® and Gadovist^® 1.0 in other regions, is the U.S. brand name of the aqueous 1.0M solution of gadobutrol, a gadolinium (Gd)-based extracellular contrast agent for MRI with a macrocyclic structure. The safety profile of Gadavist has been established in clinical trials involving 7,713 patients (including 184 pediatric patients ages 0-17). The safety and effectiveness of Gadavist have not been established in preterm neonates for any indication or in pediatric patients of any age for use with MR to assess the presence and extent of malignant breast disease, or for use in cardiac MR to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in patients with known or suspected coronary artery disease (CAD). Please see Important Safety Information, including Boxed Warning below.

INDICATIONS and IMPORTANT SAFETY INFORMATION

INDICATIONS

Gadavist^® (gadobutrol) injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):

• To detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates.
• To assess the presence and extent of malignant breast disease in adult patients.
• To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

Gadavist^® is indicated for use in magnetic resonance angiography (MRA):

• To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates.

IMPORTANT SAFETY INFORMATION

Contraindication and Important Information about Hypersensitivity Reactions:

Gadavist^® is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist^®. Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Gadavist^® administration. Before Gadavist^® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Gadavist^®.

Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible.

Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of GBCAs. Do not exceed the recommended dose in these patients.

Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Gadavist^®. Extravasation into tissues during Gadavist^® administration may result in moderate irritation.

Overestimation of Extent of Malignant Disease in MRI of the Breast: Gadavist^® MRI of the breast overestimated the histologically confirmed extent of malignancy in the diseased breast in up to 50% of the patients.

Low Sensitivity for Significant Arterial Stenosis: The performance of Gadavist^® MRA for detecting arterial segments with significant stenosis (>50% renal, >70% supra-aortic) has not been shown to exceed 55%. Therefore, a negative MRA study alone should not be used to rule out significant stenosis.

Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with Gadavist^® in clinical studies were headache (1.7%), nausea (1.2%) and dizziness (0.5%).

Please see Full Prescribing Information for Gadavist^® (Vials and Syringes).
Please see Full Prescribing Information for Gadavist^® (Imaging Bulk Package).
Please see Full Prescribing Information for Gadavist^® (Pharmacy Bulk Package).

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to www.bayer.us.

Bayer^® and the Bayer Cross^® are registered trademarks of Bayer.

Intended for U.S. Media Only

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

PP-GADA-US-0360-1 August 2020