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Lantheus Medical Imaging, makers of ABLAVAR™, is committed to the professional and patient communities we serve. In the spirit of this commitment, we invite ongoing feedback and dialogue.

Address:
Lantheus Medical Imaging, Inc.
Bldg. 200-2
331 Treble Cove Rd.
N. Billerica, MA 01862

Phone: (800) 362-2668 (for Massachusetts and International, call (978) 667-9531)

Fax: (978) 436-7501


Adverse Event and Product Quality Complaint Reports

United States

Phone: (800) 343-7851

  • Press Option 2 for Adverse Events
  • Press Option 3 for Product Quality Complaints

Fax: (866) 880-9343

Outside US/Canada
Phone: (978) 667-9531

  • Press Option 2 for Adverse Events
  • Press Option 3 for Product Quality Complaints

Fax: (734) 929-6688

E-Mail: i3drugsafetypv@i3drugsafety.com
Medical Information
For adverse events and product quality complaints, please use contact information above.

Phone: (800) 343-7851

  • Press Option 4 for Medical Information

Fax: (978) 671-8736

Hours: 8:30AM to 4:30PM Eastern Time, Monday - Friday

Customer Service

Phone: (800) 299-3431

Fax: (978) 436-7501

Hours: 7:30AM to 6:30PM Eastern Time, Monday - Friday

Sales

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Sponsorship & Grants

http://www.lantheus.com/AboutUs-Grants.html

Media Inquiry

Michele Rozen
Pure Communications

Phone: (617) 730-8284

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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 increase the risk of nephrogenic systemic fibrosis (NSF) in patients with:

  • acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
  • acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any 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 paramagnetic 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. 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).

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ABLAVAR is a trademark of Lantheus Medical Imaging, Inc. Use of the information on this site is subject to the terms of our Legal Notice and Privacy Policy.
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