There is only one Cardiolite

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We at Lantheus Medical Imaging, the makers of Cardiolite®, are committed to the professional and patient communities we serve. In the spirit of this commitment, we invite ongoing feedback and dialogue.

Headquarters
Lantheus Medical Imaging
331 Treble Cove Rd.
N. Billerica, MA 01862

Phone: 1-800-362-2668


Customer Service
Phone: 1-800-299-3431
Fax: 1-978-671-8860
Fax Orders/POs: 1-978-436-7501

Hours: 7:30 a.m. to 6:00 p.m. Eastern Time Zone, Monday - Friday


Adverse Event and Product Quality Complaint Reports

United States
Phone: 1-800-343-7851
Press Option 2 for Adverse Events
or Product Quality Complaints

Fax: 978-436-7296

Outside US
Phone: 978-667-9531
Press Option 2 for Adverse Events
or Product Quality Complaints

Fax: 978-436-7296

E-Mail: lantheussafety@lantheus.com


Medical Information
For adverse events and product quality complaints,
please use contact information above.


Phone: 1-800-343-7851 (Outside US: 978-667-9531)
Press Option 3, followed by Option , for Medical Information

Fax: 978-671-8736

Hours: 8:30 a.m. to 5:00 p.m. Eastern Time Zone, Monday - Friday

E-Mail: medicalinformation@lantheus.com


Reimbursement Support:

Phone: 1-800-362-2668
Press Option 3

Lantheus Medical Imaging cannot guarantee coverage or payment for products or procedures. Payer policies can vary widely and third party payment for medical products and services is affected by numerous factors.  It is always the provider's responsibility to determine and submit appropriate codes, charges, and modifiers for services rendered. For more specific information, contact your third-party payer directly in order to obtain up-to-date coverage, coding and payment information.


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Email adverse event and product quality complaints to:
lantheussafety@i3global.com

Email medical information inquiries to:
medicalinformation@lantheus.com

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How We'll Use This Information: Lantheus Medical Imaging may collect data from you that you provide to us voluntarily, such as your name, postal address, e-mail address, telephone number and other personal information, such as your education level, professional affiliation, marital status, or personal medical information. If you provide us with these data, you agree that we may contact you to provide you with information we believe may be of interest to you.

Your information may be provided to other parties that Lantheus Medical Imaging is working with in order to help develop programs and provide services that may be of interest to you or for processing, mailing, and/or Internet-based delivery purposes within authorized Lantheus Medical Imaging personnel in other countries. At all times, personal data are treated confidentially.

If at any time you do not wish us to contact you or if you have any questions concerning our privacy practices, please feel free to contact us at bi.webadmin@lantheus.com.

 

INDICATIONS AND USAGE FOR CARDIOLITE®:
Myocardial Imaging:  Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions.  Cardiolite® evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g. exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling).

CONTRAINDICATIONS:
None known.

IMPORTANT SAFETY INFORMATION: 
Cardiolite® has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria.  In some patients the allergic symptoms developed on the second injection during Cardiolite® imaging.  The most frequently reported adverse events include headache, chest pain/angina, ST segment changes on ECG, nausea, and abnormal taste and smell.

Infrequently, death has occurred 4 to 24 hours after Tc99m Sestamibi use and is usually associated with exercise stress testing (See Section 5.2). Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events.

WARNINGS AND PRECAUTIONS:
In studying patients in whom cardiac disease is known or suspected, care should be taken to assure continuous monitoring and treatment in accordance with safe, accepted clinical procedure.

Caution should be exercised and emergency equipment should be available when administering Cardiolite®.

Before administering Cardiolite® patients should be asked about the possibility of allergic reactions to either Cardiolite® or Miraluma®. Miraluma® is an identical compound used in breast imaging.

The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.

Please see full Prescribing Information: Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection)

 

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