ABLAVAR® - Ordering Information

Reimbursement

If you have questions about reimbursement related to ABLAVAR^®, please contact ABLAVAR^® Reimbursement Support at (800) 362-2668 ext. 7995 or complete the online request form.

2013 Medicare Reimbursement Guide

Lantheus Medical Imaging cannot guarantee coverage or payment for products or procedures. Payer policies can widely vary 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.

ABLAVAR^® Ordering Information

Ordering ABLAVAR^® directly from Lantheus Medical Imaging customer service:

Lantheus Customer Service
Phone: (800) 299-3431
Fax: (978) 436-7501
Hours: Monday to Friday, 7:30 AM to 6:30 PM (EST)

Lantheus Online Ordering System: Order ABLAVAR® Online
If you do not have an account, contact Lantheus Customer Service at (800) 299-3431.

Return Policy

Customer return policy when ordering through
Lantheus Medical Imaging

Shipping

ABLAVAR^® will be shipped at ambient temperature. Upon receipt, store ABLAVAR^® up to 25°C (77° F) and protect from light and freezing temperatures. ABLAVAR^® will be shipped via a 2-day system. For overnight delivery, a $25 handling charge will be assessed.

Lantheus Item Codes
ITEM CODE	DESCRIPTION	NDC
AUST	10-mL fill in 10-mL single-use vials/package of 10 vials	11994-0012-01
AUSF	15-mL fill in 20-mL single-use vials/package of 10 vials	11994-0012-02

McKesson Specialty Distributors is accepting ABLAVAR^® orders from the following wholesalers:

Wholesaler Order Numbers
Quantity	Amerisource/Bergen Order #	Cardinal Order #	McKesson Pharma Order #	SourceOne Order #	Merry X-Ray Order #
10X10 mL	078-910	4275988	1767086	420702	MXR #40701010
10X15 mL	078-915	4275996	1857150	420703	MXR #40701020

Return Policy

Customer return policy when ordered through any of the above listed wholesalers

ABLAVAR^® Formulary Kit

The ABLAVAR^® Formulary Kit includes information about ABLAVAR^® and blood-pool imaging, ordering and contact information, clinical abstracts from pivotal Phase 2 and 3 trials, dosing guidelines, and full Prescribing Information, including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF).

ABLAVAR® Formulary Kit (Not available- undergoing revision)

INDICATIONS:

ABLAVAR^® is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.

CONTRAINDICATIONS:

History of a prior allergic reaction to a gadolinium-based contrast agent.

IMPORTANT SAFETY INFORMATION:

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

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 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 ABLAVAR dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.

ABLAVAR^® Injection: As with other contrast media, the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered. As with other gadolinium based contrast agents, caution should be exercised in patients with renal insufficiency due to the possibility of further deterioration in renal function.

In clinical trials, a small increase (2.8 msec) in the average change from baseline in QTc was observed at 45 minutes following ABLAVAR^® administration. These QTc prolongations were not associated with arrhythmias or symptoms. Caution should be used in patients at high risk for arrhythmias due to baseline QTc prolongation.

Have emergency resuscitative equipment available prior to and during ABLAVAR^® administration.

Please see full Prescribing Information, including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF).