PRIVACY POLICY

 

Who We Are                                      

This site is owned by Bracco Diagnostics Inc.

Thank you for visiting this online portal, website, or mobile application, which is owned and operated by Bracco Diagnostics Inc., and/or one of its parent corporations, subsidiaries or affiliates (collectively “BDI,” “We” or “Our“). BDI is committed to respecting your privacy, and this Privacy Policy is intended to answer your important questions about how BDI may process your Personal Data about you through your online and off-line interactions with BDI through BDI services, products, communications, and digital properties that refer to this Privacy Policy.

BDI, the U.S.-based subsidiary of Bracco Imaging SpA, and part of the Bracco Group, is a leader in innovative contrast imaging agents in the U.S. BDI, established in 1994, with headquarters and research offices in Monroe Township, NJ, offers a product and solution portfolio for all key diagnostic imaging modalities: X-Ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers. The diagnostic imaging offer is completed by several medical devices and advanced administration systems for contrast imaging products in the fields of radiology.

This Privacy Policy applies regardless of whether you access or use this site via a computer, mobile device or other platform. This Privacy Policy also applies to personal information we obtain through email communications, our online channels (including other websites, online product catalogs, mobile applications and social media websites that reference this Privacy Policy) and to personal information you provide us offline, e.g. at trade shows or sales exhibitions, when you place an order over the phone or when you contact our customer service (all such online channels, websites, online product catalogs, mobile applications and social media sites shall collectively be referred to herein as the “Services”). 

Please carefully read this Privacy Policy to learn more about how we collect, use, disclose and store information provided and the steps we take to help protect the often-sensitive information provided from unauthorized use or disclosure. When you submit information to or through the Services, you consent to the collection, processing and retention of your information as described in this Privacy Policy.

This Privacy Policy is incorporated into and made a part of our Terms of Service. If you have not done so already, please also review BDI’s Terms of Service. The Terms of Service contain provisions that limit BDI’s liability to users of the Services.

IF YOU DO NOT AGREE WITH ANY PART OF THIS PRIVACY POLICY, THEN PLEASE DO NOT USE ANY OF THE SERVICES.

Please note that this Privacy Policy does not apply to information collected through third-party websites or services that you may access through the Services.

I. INFORMATION WE COLLECT

When you use the Services, we collect the following:

  • Data you provide us (for example, your name, address, phone number, email address, employer information, and demographic data such as gender and date of birth (“Personal Information”)).
  • Data obtained from our partners (partners may include but are not limited to market research firms and logistics information providers).
  • Data obtained from Third Parties or Publicly Available Sources (see details below)
  • Data obtained through cookies and other means.


II. HOW INFORMATION IS COLLECTED AND USED

BDI collects and uses information to operate the Services, including:

Information That You Voluntarily Provide When Using the Services. We collect and use the Personal Information that you voluntarily provide to us through the Services. You may use certain Services without registering or identifying yourself but, if you do not register, you may not have access to all of the Services. If you choose to register, we may use the Personal Information you provide to confirm your registration and to respond to requests from you. Upon your request, we may also use the Personal Information to send you special promotions, newsletters or other information that may interest you.

If you are a healthcare professional or an institutional healthcare provider (collectively, “Providers”), you are responsible for obtaining any legally required authorization, consent or other permission from your patients prior to providing their Personal Information to BDI through the Services. By submitting any Personal Information about a patient, you represent and warrant to BDI that you have obtained all required permissions to do so.

Through Your Use of Interactive Services. If you choose to participate in our questionnaires and surveys and other interactive Services, we will collect the information that you share to help us better understand how BDI products are used in diagnosing and treating diseases for which they are marketed.

The information you provide through interactive Services may be combined (subject to all applicable laws) with the Personal Information provided elsewhere in or through the Services. We may combine your and others’ Personal Information to create summary data that we will use for our business purposes, such as research to improve our products and analyses that may help us better market our products.

You may provide information to be published or displayed (“Posted“) on public areas of the Services (collectively, “User Contributions“). Your User Contributions are Posted and made available publicly at your own risk. BDI does not control the actions of third parties with access to your User Contributions.

When you Correspond with BDI about BDI Products. If you contact BDI or use the Services to ask questions or report problems regarding your experience in using one of our products, we may use the information you provide in submitting reports to the U.S. Food and Drug Administration and as otherwise required of us by law. We also may use the information to contact the prescribing physician to follow up regarding an event involving use of our product.

Through Data Collection Tools.  BDI also automatically collects information about use of the Services through data collection tools, such as web beacons and cookies.

A “web beacon” is a piece of code that enables us to monitor user activity and website traffic. A “cookie” is a randomly-generated unique numeric code stored in the user’s web browser settings or computer’s hard drive. A cookie typically contains the name of the domain (internet location) from which the cookie originated, the “lifetime” of the cookie (i.e., when it expires), as well as the randomly generated unique numeric code.

We use the information collected through data collection tools to monitor usage patterns, store information about user preferences and to improve the Services. For example, your Personal Information may be used to create customized offers, information and services tailored to your interests and preferences.  We may track your activities over time and across third-party websites, apps or other online services to display advertisements on third-party websites. If you do not want us to use your information in this way, please see “Your Privacy Choices” below. For more information about our digital advertising practices, please see “Digital Advertising” below.

When you Connect with Social Media though the Services: Certain Services may link with social media platforms and social media plug-ins (e.g., the Facebook “Like” button, “Share to Twitter” button) (collectively, “Social Media”). When accessing the Services through a Facebook or other Social Media account, BDI may (depending on the applicable user privacy settings) automatically have access to information provided to or through the Social Media platform. BDI may collect and use this information for the purposes described in this Privacy Policy or at the time the information was collected.

Through Service Providers or Publicly Available Sources: We may receive information about you from other sources, including publicly available databases or third parties from whom we have purchased data, and combine this data with information we already have about you. This helps us to update, expand and analyze our records, identify new customers, and provide products and services that may be of interest to you. If you provide us Personal Information about others, or if others give us your information, we will only use that information for specific reasons for which it was provided to us.

Examples of the types of personal information that may be obtained from public sources or purchased from third parties and combined with information we already have about you, may include:

  • Address information about you from third party sources, such as the U.S. Postal Service, to verify your address so we can properly ship your order to you and to prevent fraud.
  • Purchased marketing data about our customers from third parties that is combined with information we already have about you, to create more tailored advertising and products.

In addition. third parties that assist us with our business operations also collect and use information (including Personal Information and Usage Data) through the Services and also may share the collected information with us. For example, our vendors collect and share information with us to analyze use of the Services, to help us detect and prevent fraud and to improve user experience.

III. HOW INFORMATION IS SHARED AND DISCLOSED

We may share and disclose information as described at the time information is collected and as follows:

To Perform Services. We may use third parties to perform services requested or functions initiated by users. In addition, we may disclose Personal Information to identify a user in connection with communications sent through the Services. We also may offer users the opportunity to share information with friends and other users through the Services.

With BDI’s Third Party Contractors. We share information, including Personal Information, with our service providers to perform the functions for which we engage them, such as data analysis, system design and maintenance, customer services and for marketing and promotions.

With Co-branding Partners. We may partner with other companies to provide you with content or services on a joint or “co-branded” basis. When websites or services are co-branded, you will see both the BDI logo and the logo of our co-branding partner. When you register for a co-branded website or service, your registration information may be shared with one or more of BDI’s co-branding partners. You may avoid sharing your information with BDI’s partners on co-branded sites or service by choosing not to use them. Each co-branding partner will have its own privacy policy and its privacy practices may differ from this Privacy Policy.

Data obtained through text messaging short code programs will not be shared with any third-parties for their marketing reasons/purposes.

Social Media Plugins. When you use the Services, Social Media operators can place a cookie on your computer to recognize individuals who have previously visited the Services. If you are logged into a Social Media account while using the Services, the social plugins allow that Social Media to receive information that you have accessed and used the Services. The social plugins also allow the Social Media operator to share information about your activities in or through the Services with other Social Media users. For example, Facebook Social Plugins allows Facebook to show your Likes and comments on our pages to your Facebook friends. Facebook Social Plugins also allows you to see your friends’ Facebook activity through the Services. BDI does not control any of the content from the Social Media plugins. For more information about Social Media plugins, please refer to the privacy statements and other legal notices of the Social Media platform.

Legal Requirements. In certain circumstances, BDI may release your Personal Information in response to a court order, subpoena, search warrant, regulation, binding order of a data protection agency, governmental request or other legal or regulatory process. BDI may disclose information if we believe disclosure is necessary or appropriate to protect the rights, property, or safety of BDI and our customers or others.

Corporate Changes. We may transfer information, including your Personal Information, in connection with a merger, sale, acquisition, divestiture, restructuring, reorganization, dissolution, bankruptcy or other change of ownership or control by BDI or any affiliated company (in each case, whether in whole or in part). When one of these events occurs, BDI will use reasonable efforts to notify users before information is transferred or becomes subject to different privacy practices.

IV. DIGITAL ADVERTISING

We use third-party advertising companies to serve ads on other websites and digital services. These companies may use information obtained from data collection tools in order to measure advertising effectiveness and to provide advertisements of interest to you.

You can opt out here or if you are located in the European Union, by clicking here so as not to receive targeted ads from use of the tools, but this will not affect any general advertisements you may receive.

V. LINKS TO OTHER WEBSITES/SERVICES

A link to a third-party website or digital service does not mean that BDI endorses it or the quality or accuracy of information presented on it. If you decide to visit a third-party website or service, you are subject to its privacy practices and not this Privacy Policy. We encourage you to carefully read the privacy policy or statement and other legal notices of each website or service that you visit.

VI. OUR CHILDREN’S POLICY

The Services are not intended for use by children. If you are under the age of majority in your place of residence, you may use the Services only with the consent of or under the supervision of your parent or legal guardian. Consistent with the requirements of the Children’s Online Privacy Protection Act (COPPA), if we learn that a child under age 13 has provided Personal Information to or through the Services without first receiving his or her parent’s verified consent, we will use that information only to respond directly to that child (or his or her parent or legal guardian) to inform the child that he or she cannot use the Services and subsequently we will dispose of such Personal Information in accordance with this Privacy Policy.

If you believe BDI may have any information from or about a child under age 13, please contact our Privacy Office using the contact information at the end of this Privacy Notice.

VII. YOUR PRIVACY CHOICES

BDI aims to provide you with choices regarding the Personal Information you provide to us. This section describes mechanisms that we offer you to control certain uses and disclosures of your information.

When you access any interactive Service, you will be asked to affirmatively choose (“opt in“) to provide the requested information. You may always choose not to provide the requested information but then you may not be able to use the Service as intended.

Correct/Update Personal Information. You may correct or update the Personal Information you previously provided to BDI, by sending an email to privacy@diag.bracco.com .

Receive Marketing Communications. When you register for the Services, you may request to receive email containing information about BDI that we think you might find useful, including promotions, announcements of new services and products, and newsletters on particular health topics. If you decide, at any time, that you no longer wish to receive these emails you may unsubscribe from our email list by clicking the “unsubscribe” link included in all of our marketing emails. You may also opt-out from receiving these emails by contacting us at privacy@diag.bracco.com .

Accept and Reject Cookies. Your browser software can be set to reject all cookies, but if you reject our cookies, certain of the functions and conveniences of the Services may not work properly. To learn more about cookies, please check your browser’s help or similar feature or visit allaboutcookies.org .

How We Respond to Browser “Do Not Track” Signals. Some web browsers incorporate a “do-not-track” or similar feature that signals to websites with which the browser communicates that a visitor does not want to have his/her online activity tracked. If a digital service that responds to a particular DNT signal receives the DNT signal, the browser can block that digital service from collecting certain Personal Information about the browser’s user. As of the Effective Date not all browsers offer a DNT option and DNT signals are not yet uniform. For this reason, BDI along with many other digital service operators do not currently respond to DNT signals. For more information about DNT signals, visit allaboutdnt.com .

IMPORTANT NOTE: BDI cannot comply with a consumer’s request to amend or remove information that was provided to BDI by a healthcare professional or a consumer regarding an adverse drug event.

VIII. HOW INFORMATION IS RETAINED AND SECURED

We retain information as long as it is necessary and relevant for our operations. In addition, we retain Personal Information to comply with applicable law, prevent fraud, resolve disputes, troubleshoot problems, assist with any investigation, enforce our Terms of Service, and other actions permitted by law. When your Personal Information is no longer needed for BDI’s business purposes, we dispose of it subject to applicable law.

In accordance with applicable laws, we employ reasonable security measures intended to help protect the security of all information submitted through the Services. The security of information transmitted through the internet cannot, however, be guaranteed. We are not responsible for any interception or interruption of any communications or for changes to or losses of data through the internet. Users of the Services are responsible for maintaining the security of any password, user ID or other form of authentication involved in obtaining access to password protected or secure areas of the Services. Any access to the Services through your user ID and password will be treated as authorized by you. To help protect your Personal Information, we may suspend your use of all or part of the Services, without notice, if BDI suspects or detects any breach of security. Unauthorized access to such areas is prohibited and may lead to criminal prosecution.

IX. CHANGES TO THIS PRIVACY POLICY

BDI reserves the right to change the terms of this Privacy Policy. If we make any material changes to this Privacy Policy, we will notify you in advance through the Services. If we decide to use Personal Information in a manner that is materially different from the uses described in this Privacy Policy or otherwise disclosed to you, you will have the choice to allow or disallow any additional uses or disclosures of your Personal Information. We will not make retroactive changes that reduce your privacy rights unless we are legally required to do so. Your continued use of the Services after the Effective Date constitutes your acceptance of the amended Privacy Policy. The amended Privacy Policy supersedes all previous versions.

X. YOUR CALIFORNIA PRIVACY RIGHTS

If you are a California resident under age 18 and are a registered user of any of the Services, then you may request that we remove any of your User Contributions (defined in Section II) you publicly posted on or in the Services. To request removal of your User Contribution, please send a request with a detailed description of the specific User Contribution to the Privacy Office at the contact information below. (You also may be able to log in to your account and delete your own User Contribution.) BDI reserves the right to request that you provide information that will enable us to confirm that the User Contribution that you want removed was created and posted by you.

BDI will make a good faith effort to delete or remove your User Contribution from public view as soon as reasonably practicable. Please note, however, that your request that we delete your User Contribution does not ensure complete or comprehensive removal of your User Contribution. Your User Contribution may remain on backup media, cached or otherwise retained by BDI for administrative or legal purposes or your User Contribution may remain publicly available if you or someone else has forwarded or re-posted your User Contribution on another website or service prior to its deletion. BDI may also be required by law to not remove (or allow removal) of your User Contribution.

California Civil Code Section 1798.83 permits individual California residents to request certain information regarding BDI’s disclosure of personal information to third parties for their direct marketing purposes. To make such a request, please write or send an email to the address below.

California Consumer Privacy Act – Notice for California Residents

If you are a California resident, this Privacy Notice supplements the information above regarding the collection, use, and disclosure of your personal information.

The California Consumer Privacy Act of 2018 (CCPA) gives California consumers the right to know what personal information is collected about them, how it will be used and to whom it is disclosed.  The CCPA gives California consumers the right to request access to and deletion of their personal information, and the right to request that their personal information not be sold to the extent applicable under the CCPA.

The purpose of this notice is to describe our practices regarding the collection, use, disclosure, and sale of personal information and instructions for submitting CCPA data privacy requests.  Some of the Personal Information that we collect, use, and disclose may be exempt from the CCPA because it is regulated by other federal and state laws that apply to us.

We collect personal information from you when you interact with us online through our Services or offline. The personal information we may collect from you will depend on the nature of our interaction with you, but can include the following categories that we have collected in the preceding twelve (12) months:

Personal Information Category

  • Identifiers such as
    • Name
    • Address
    • Unique personal identifier (e.g., device ID, online identifier)
    • Internet Protocol address
    • Email address
    • Account name
    • Social security number
    • Driver’s license number, or
    • Other similar identifiers
  • Characteristics of protected classifications under California/federal law (e.g., age, race, sex, medical condition, etc.)
  • Medical information
  • Health insurance information
  • Financial information, including credit card numbers
  • Biometric information (e.g., imagery of the iris, retina, fingerprint, face, or other data that contain identifying information)
  • Commercial information (e.g., purchase history)
  • Internet or other electronic network activity information (e.g., browsing history, interaction with our website, etc.)
  • Geolocation data
  • Audio, electronic, visual, thermal, olfactory, or similar information (e.g., call recordings)
  • Professional, employment-related, or other similar information

 

“Personal Information” under the CCPA does not include information that is

  • publicly available from government records,
  • de-identified or aggregated consumer information,
  • health or medical information covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the California Confidentiality of Medical Information Act (SMIA) or clinical trial, or
  • certain personal or financial information covered under certain sector-specific privacy laws.

For additional information, please see our Privacy Policy.

 

Categories of Sources of Personal Information

We obtain the categories of personal information listed above from the following categories of sources:

  • Directly from consumers’ interactions with us, including with our devices, applications, websites, services, and representatives
  • Publicly available sources
  • Customers, including health care providers and insurance providers
  • Organizations with whom we partner to provide services to consumers

 

Use or Disclosure of Personal Information

In the past 12 months, we have used or disclosed the personal information we collect for our operational purposes and for one or more of the following business purposes:

  • Collect email addresses for the purpose of emailing investor relations information.
  • Collect postal addresses in order to deliver information and products via mail.
  • To answer your requests.
  • To negotiate or conclude a contract with you or about you.
  • To contact you by mail (or other means with your permission) to provide you with information that may be of interest to you, including information about clinical trials, our products and services or the products and services of others.
  • For analytical purposes and to study, develop and improve programs, products, treatments, services and content.
  • To delete information that identifies you (your name, email address, social security number, etc.). In this case, you are no longer identified as an individual. Once we have de-identified information, it becomes non-personal information that is no longer subject to these privacy principles.
  • To personalize your access to our sites, for example, by informing you of any news that may interest you.
  • To enforce these privacy principles and to protect our rights or property.
  • To protect your vital interests or the health, safety or well-being of someone else.
  • To comply with any law or regulation, court order or other legal obligation.
  • For our other legitimate interests unless such treatment is prejudicial to your rights or your liberties.
  • In any other way with your consent.

How We Share Personal Information

Bracco will not share consumers’ personal information with an unrelated third party without permission, except as described below. Bracco may share personal information with any member of our corporate group, including parent companies, subsidiaries, and affiliates, and other companies in which we have an ownership or economic interest for purposes that are consistent with those identified in our Privacy Policy and this Supplemental Privacy Notice.

In the ordinary course of business, we will share some personal information with companies that we hire to perform services or functions on our behalf. In all cases in which we share consumers’ personal information with a third party, we will only allow them to keep, disclose, or use consumers’ information to provide the services we asked them to provide.

We may be required to release consumers’ personal information in response to a court order, subpoena, search warrant, law, or regulation. We may cooperate with law enforcement authorities in investigating and prosecuting users who violate our rules or engage in behavior which is harmful to other users or illegal. In addition, we may keep, disclose, and use consumers’ personal information in order to comply with U.S. FDA and other governmental guidance, directions, regulations, and laws.

Categories of Personal Information We Sell

We do not sell personal information of California consumers except as part of a sale, merger, dissolution, or acquisition of the business.

This does not include disclosures that are not a “sale” under the CCPA, including when

  • consumers instruct us to disclose their personal information,
  • a consumer instructs us to interact with a third party that does not sell that information,
  • we use or share consumers’ personal information pursuant to a written contract with a service provider that is necessary to perform a business purpose, where our contract prevents the provider from using, keeping, or disclosing consumers’ personal information for any purpose other than the reason supplied in the contract, or
  • consumers’ personal information is transferred as part of a transaction in which the third party assumes control of all or part of our business.

Personal Information on Minors

We do not sell personal information of California consumers, including minors.

Your Rights Under California Law

The CCPA provides you (as a California resident) with specific rights subject to certain exceptions.

  • The Right to Know.  Before or at the time we collect Personal Information from you, you have the right to receive notice of the Personal Information to be collected and the purposes for which we use it. This Privacy Notice is intended to satisfy this requirement. You also have the right, under the CCPA, to request that we disclose to you the categories of Personal Information we have collected about you in the preceding 12 months, along with the categories of sources from which the Personal Information was collected, the purpose for collecting or selling the Personal Information, the categories of third parties with whom we shared the Personal Information, and the categories of third parties to whom we sold the Personal Information, if any. The process for exercising this right is describe below under How to Submit a Data Privacy Request
  • The Right to Deletion.  You have the right under the CCPA to request deletion of any personal information about you that we have collected from you.  However, in certain situations we are not required to delete your Personal Information, such as when the information is necessary in order to complete the transaction for which the Personal Information was collected, to provide a good or service requested by you, to comply with a legal obligation, to engage in research, to secure our websites or other online services, or to otherwise use your Personal Information internally in a lawful manner that is compatible with the context in which you provided the information. The process for exercising this right is describe below under How to Submit a Data Privacy Request  
  • The Right to Opt-Out of the Sale of Personal Information.  You have the right under the CCPA to opt-out of the sale of your personal information.
  • The Right to Non-Discrimination.   You have the right under the CCPA not to be discriminated against for exercising your rights under the CCPA as described above.

 

How to Submit a Data Privacy Request

If you are a California resident and you want to submit a request or inquiry to us regarding your California rights, you or your authorized agent can contact us as follows:

privacy@diag.bracco.com
Bracco Diagnostics Inc.
c/o Data Protection Focal Point
Legal and Compliance Department
259 Prospect Plains Road, Building H
Monroe Township, New Jersey 08831
609-514-2203

 

You do not have to create an account with us to submit a request.

Your request will be confirmed within 10 days of receipt and we will respond within 30 days. If we need more than 30 days, we will notify you that your request is being delayed.

We can only respond to your request if it is verifiable. This means we are obligated to take reasonable steps to verify your identity or your authorized agent’s authority and your right to access the information you request. We may ask for additional information that will help us do so. We will only use that additional information in the verification process, and not for any other purpose.

We do not charge a fee to process or respond to your verifiable consumer request unless it is excessive, repetitive, or manifestly unfounded. If we determine that the request warrants a fee, we will tell you why we made that decision and provide you with a cost estimate before completing your request.

XI. NEVADA RESIDENTS AS COVERED BY NEVADA PRIVACY LAW

BDI does not sell Covered Information as defined under Nevada law. If you would like to make a further inquiry regarding the selling of your Covered Information, as defined under Nevada law, please send an email to the Privacy Office at the email address provided below.

Contact Us

privacy@diag.bracco.com
Bracco Diagnostics Inc.
c/o Data Protection Focal Point
Legal and Compliance Department
259 Prospect Plains Road, Building H
Monroe Township, New Jersey 08831
609-514-2203

Be sure to include your name, address, and email address if you want to receive a response by email. Otherwise, we will respond by postal mail within the time required by applicable law.

Effective Date: August 1, 2022

 

 

IMPORTANT SAFETY INFORMATION | INDICATIONS AND USAGE

MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL and ProHance® (Gadoteridol) Injection, 279.3 mg/mL

IMPORTANT SAFETY INFORMATION for MultiHance and ProHance:

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs.

  • The risk for NSF appears highest among patients with:
    • chronic, severe kidney disease (GFR <30 mL/min/1.73m2) or
    • acute kidney injury.
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended MultiHance/ProHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.

 

MultiHance (gadobenate dimeglumine) injection, 529 mg/mL

CONTRAINDICATIONS

MultiHance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents.

WARNINGS AND PRECAUTIONS

Nephrogenic Systemic Fibrosis: NSF has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeated dosing appears to increase risk.

Hypersensitivity Reactions: Anaphylactic and anaphylactoid reactions have been reported, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of MultiHance administration and resolved with prompt emergency treatment. Consider the risk for hypersensitivity reactions, especially in patients with a history of hypersensitivity reactions or a history of asthma or other allergic disorders.

Gadolinium Retention:  Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by brain, skin, kidney, liver, and spleen. 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. Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible.

Acute Renal Failure: In patients with renal insufficiency, acute renal failure requiring dialysis or worsening renal function have occurred with the use of GBCAs. The risk of renal failure may increase with increasing dose of the contrast agent. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests.

Extravasation and Injection Site Reactions: Extravasation of MultiHance may lead to injection site reactions, characterized by local pain or burning sensation, swelling, blistering, and necrosis. Exercise caution to avoid local extravasation during intravenous administration of MultiHance.

Cardiac Arrhythmias: Cardiac arrhythmias have been observed in patients receiving MultiHance in clinical trials. Assess patients for underlying conditions or medications that predispose to arrhythmias. The effects on QTc by MultiHance dose, other drugs, and medical conditions were not systematically studied.

Interference with Visualization of Certain Lesions: Certain lesions seen on non-contrast images may not be seen on contrast images. Exercise caution when interpreting contrast MR images in the absence of companion non-contrast MR images.

ADVERSE REACTIONS

The most commonly reported adverse reactions are nausea (1.3%) and headache (1.2%).

USE IN SPECIFIC POPULATIONS

Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. Use only if imaging is essential during pregnancy and cannot be delayed.

Lactation: There is no information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. However, limited literature reports that breastfeeding after MultiHance administration to the mother would result in the infant receiving an oral dose of 0.001%-0.04% of the maternal dose.

Pediatric Use: MultiHance is approved for intravenous use for MRI of the CNS to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to less than 17 years of age. Adverse reactions in pediatric patients were similar to those reported in adults. No dose adjustment according to age is necessary in pediatric patients two years of age and older. For pediatric patients, less than 2 years of age, the recommended dosage range is 0.1 to 0.2 mL/kg. The safety of MultiHance has not been established in preterm neonates.

ProHance (Gadoteridol) Injection, 279.3 mg/mL

CONTRAINDICATIONS

Contraindicated in patients with known allergic or hypersensitivity reactions to ProHance.

WARNINGS AND PRECAUTIONS

Nephrogenic Systemic Fibrosis: NSF has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeated dosing appears to increase risk.

Hypersensitivity Reactions: Anaphylactic and anaphylactoid reactions have been reported, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of administration and resolved with prompt emergency treatment. Prior to ProHance administration, ensure the availability of trained personnel and medications to treat hypersensitivity reactions. Consider these risks, especially in patients with a history of hypersensitivity reactions or a history of asthma or other allergic disorders.

Gadolinium Retention: Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by brain, skin, kidney, liver, and spleen. Linear GBCAs cause more retention than 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.

Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging.

ADVERSE REACTIONS

The most commonly reported adverse reactions are nausea and taste perversion with an incidence ≥ 0.9%.

USE IN SPECIFIC POPULATIONS

Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. Use only if imaging is essential during pregnancy and cannot be delayed.

Lactation: There are no data on the presence in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk.

Pediatric Use: The safety and effectiveness of ProHance have been established for use with MRI to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to 17 years of age. Adverse reactions in pediatric patients were similar to those reported in adults. No case of NSF associated with ProHance or any other GBCA has been identified in pediatric patients ages 6 years and younger.

Indications and Usage for MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL:

  • Magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates) to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues
  • Magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease

Indications and Usage for ProHance® (Gadoteridol) Injection, 279.3 mg/mL:

CENTRAL NERVOUS SYSTEM
ProHance is indicated for use in MRI in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine, and associated tissues.

EXTRACRANIAL/EXTRASPINAL TISSUES
ProHance is indicated for use in MRI in adults to visualize lesions in the head and neck.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

Please see full Prescribing Information and Patient Medication Guide for MultiHance here.

Please see full Prescribing Information and Patient Medication Guide for ProHance here.

MultiHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany) and by Patheon Italia S.p.A, Ferentino, Italy.

ProHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany).

MultiHance is a registered trademark of Bracco International B.V.

ProHance is a registered trademark of Bracco Diagnostics Inc.

All other trademarks and registered trademarks are the property of their respective owners.

IMPORTANT SAFETY INFORMATION  |  INDICATIONS AND USAGE

MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL and ProHance® (Gadoteridol) Injection, 279.3 mg/mL

IMPORTANT SAFETY INFORMATION for MultiHance and ProHance:

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs.