Ordering &
Reimbursement

Two professionals using a tablet to discuss ordering and reimbursement options for DEFINITY®, enhancing operational efficiency

To order DEFINITY®:

Monday-Friday 7:30 AM to 6:00 PM ET

Call: 1.800.299.34311.800.299.3431

Online: https://weborders.lantheus.com

Ordering Information

Catalog Number

DE16

PS16

VMIX2

Description

16-Vial Kit
US DEFINITY®

PINSYNC® – Box of 16

VIALMIX® RFID *

Image of DEFINITY®, VIALMIX®, and PINSYNC® products

DEFINITY® is shipped for overnight delivery and requires refrigeration upon arrival.

Reimbursement

Medicare Reimbursement for DEFINITY®

Lantheus 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.

To learn about Medicare reimbursement for DEFINITY®, download our brochure
If you still have questions about reimbursement, contact DEFINITY® Reimbursement Support at 1.800.362.26681.800.362.2668 x7995 or email reimbursement@lantheus.com

DEFINITY® Return Policy

It is not the policy of Lantheus Medical Imaging, Inc. to issue refunds for products. However, credit or replacement may be available for the following reasons:

Lost or damaged goods if reported within two weeks of receipt of damaged product
Pricing discrepancies
Technical/performance problems, such as product fails to appear milky white after activation
Product shipped in excess of requested order if reported within two weeks of customer receipt of excess product

Terms for Returns

Replacements will be authorized only for complete boxes (not individual vials) and shipped at the original order price
Credit for items returned due to technical/performance problems will be issued upon receipt of defective material

To initiate a return, contact Customer Service at 1.800.299.3431 and request authorization for return.

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*VIALMIX® and VIALMIX® RFID are provided at no charge to customers who use DEFINITY®.

INDICATION

DEFINITY® is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: SERIOUS CARDIOPULMONARY REACTIONS

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration.

Assess all patients for the presence of any condition that precludes DEFINITY^® administration.
Always have resuscitation equipment and trained personnel readily available.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

BOXED WARNING: SERIOUS CARDIOPULMONARY REACTIONS

Assess all patients for the presence of any condition that precludes DEFINITY® administration.
Always have resuscitation equipment and trained personnel readily available.

CONTRAINDICATIONS:

Contraindicated in patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG).

WARNINGS AND PRECAUTIONS:

Serious Cardiopulmonary Reactions have occurred during or following administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias).

Serious Hypersensitivity Reactions have been observed during or shortly following administration including anaphylaxis, with manifestations that may include death. DEFINITY® contains PEG and may increase risk of serious reactions including death in patients with prior hypersensitivity reaction(s) to PEG. Clinically assess patients for prior hypersensitivity reactions to products containing PEG. Monitor all patients for hypersensitivity reactions.

Systemic Embolization may occur in patients with a cardiac shunt. Assess patients with shunts for embolic phenomena following administration. DEFINITY® is only for intravenous administration and must not be administered by intra-arterial injection.

There is a risk of Ventricular Arrhythmia Related to High Mechanical Index. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. The maximum recommended mechanical index for use with DEFINITY® is 0.8 in adult patients and 0.3 in pediatric patients.

Acute Pain Episodes in Patients with Sickle Cell Disease (SCD) shortly following administration have been reported. Discontinue DEFINITY® in SCD patients experiencing new or worsening pain.

ADVERSE REACTIONS:

The most common adverse reactions (≥0.5%) are headache, back/renal pain, flushing, nausea, chest pain, injection site reactions, and dizziness.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information and Important Safety Information, including boxed WARNING regarding serious cardiopulmonary reactions.

DEFINITY® Customer Service 1.800.299.3431

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Ordering &
Reimbursement

To order DEFINITY®: