PRINCETON, N.J., Nov. 13, 2014 /PRNewswire/ -- Guerbet LLC, USA -- Guerbet, a pioneer in the field of contrast agents for medical imaging will once again have a major exhibit presence at Radiology Society of North America (RSNA)'s 100th Assembly and Annual Meeting November 30 - December 5 in Chicago. Guerbet will be exhibiting at Booth #1914 in South Building, Hall A. This year the company will highlight its two latest contrast agents approved for use in the US: Dotarem® (gadoterate meglumine) Injection and Lipiodol® (ethiodized oil) Injection. Important safety information about these products, including their respective Boxed Warnings, appears below.
In addition, Guerbet is pleased to announce that five abstracts from studies for which Guerbet provided financial support have been accepted by RSNA for this year’s meeting.
Dotarem (gadoterate meglumine) Injection is a gadolinium-based contrast agent (GBCA) indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity. It was approved by FDA in March 2013. As of August 31, 2014 there have been over 48 million Dotarem doses administered worldwide.1
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.
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Guerbet has recently gained greater market access for Dotarem via a new supplier agreement with Premier, Inc., a leading U.S. group purchasing organization (GPO) with a membership of approximately 3000 hospitals. The agreement for Dotarem is effective January 1, 2015.
Lipiodol, the first iodinated contrast agent in the world, first used in radiology in France in 1921, was approved by FDA earlier this year for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC). HCC is the most common primary liver tumor and represents the second leading cause of death due to cancer in the world2,3, with prevalence in US estimated to affect in the range of 35,000 U.S. patients in 20134.
WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose. |
Guerbet recently received a Drug Shortage Assistance Award from the U.S. Food and Drug Administration for its efforts related to the shortage of Lipiodol (ethiodized oil) Injection, previously marketed under the brand name Ethiodol.
Massimo Carrara, Guerbet US General Manager commented: “We are very pleased that this RSNA will mark the first time Guerbet presents both of these long-established contrast agents to US radiologists.”
He added: “There has been an increasingly growing adoption of Dotarem during its first year of availability and we are especially pleased with our new supplier agreement with Premier. Lipiodol’s exit from a temporary importation program, after the approval of the finished product manufacturer and a new indication from the FDA, is providing an additional expansion of the product availability on the US market.”
Lipiodol is indicated for hysterosalpingography in adults, lymphography in adults and children, and selective hepatic intra-arterial use for imaging tumors in adults with known HCC.
Important Safety Information for Dotarem
Contraindicated in patients with a history of clinically important hypersensitivity reactions to Dotarem.
The possibility of serious or life-threatening anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, should be considered. Monitor patients closely for need of emergency cardiorespiratory support.
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. Screen all patients for renal impairment by obtaining a history and/or laboratory tests. Consider follow-up renal function assessments for patients with a history of renal dysfunction.
Ensure catheter and venous patency before the injection of Dotarem. Extravasation into tissues during Dotarem administration may result in tissue irritation.
The most common adverse reactions associated with Dotarem in clinical studies were nausea, headache, injection site pain, injection site coldness, and burning sensation.
To report Suspected Adverse Reactions, contact GUERBET LLC at 1-877-729-6679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information about Dotarem, including Boxed WARNING, please see the Full Prescribing Information.
Important Safety Information for Lipiodol
Contraindications:
Lipiodol is contraindicated in patients with hypersensitivity to Lipiodol, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding.
Lipiodol hysterosalpingography is contraindicated in pregnancy, acute pelvic inflammatory disease, marked cervical erosion, endocervicitis and intrauterine bleeding, in the immediate pre-or postmenstrual phase, or within 30 days of curettage or conization.
Lipiodol lymphography is contraindicated in right to left cardiac shunt, advanced pulmonary disease, tissue trauma or hemorrhage, advanced neoplastic disease with expected lymphatic obstruction, previous surgery interrupting the lymphatic system, or radiation therapy to the examined area.
Lipiodol selective hepatic intra-arterial injection is contraindicated in the presence of dilated bile ducts unless external biliary drainage was performed before injection.
Warnings and Precautions:
Pulmonary and cerebral embolism may occur immediately or after a few hours to days from inadvertent systemic vascular injection or intravasation of Lipiodol. Avoid use in patients with severely impaired lung function, cardiorespiratory failure or right-sided cardiac overload.
Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Lipiodol administration. Avoid use in patients with a history of sensitivity to other iodinated contrast agents, bronchial asthma or allergic disorders because of an increased risk of a hypersensitivity reaction to Lipiodol.
Lipiodol hepatic intra-arterial administration can exacerbate chronic liver disease.
Iodinated contrast media can affect thyroid function because of the free iodine content and can cause hyperthyroidism or hypothyroidism in predisposed patients.
Adverse Reactions:
Adverse reactions caused by Lipiodol include hypersensitivity reactions, pulmonary and cerebral embolism, pulmonary dysfunction, exacerbation of liver disease, procedural complications, abdominal pain, fever, nausea, vomiting, and thyroid dysfunction.
To report Suspected Adverse Reactions, contact GUERBET LLC at 1-877-729-6679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information about Lipiodol, including full Boxed WARNING, please see the Full Prescribing Information.
About Guerbet
A pioneer in the field of contrast agents with more than 80 years of experience, Guerbet is the only pharmaceutical group fully dedicated to medical imaging worldwide. As such it has a complete offering of contrast products for X-ray and MRI and for Interventional Radiology, along with a range of injectors and related medical equipment to provide improved diagnosis and treatment of patients. To promote the discovery of new products and assure future growth, Guerbet devotes significant resources to research and development every year (approximately 10% of sales). Guerbet (GBT) is listed on the NYSE Euronext Paris (Eurolist Segment B Mid Caps) and had sales of 390 million in 2013 with a total workforce of 1,485 employees. For additional information about Guerbet please go to www.guerbet.com.
This press release may contain forward-looking statements based on current assumptions and forecasts made by Guerbet Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performances of the company and the estimates given here. These factors include those discussed in Guerbet’s public reports which are available on the Guerbet website at www.guerbet.com. The company assumes no liability whatsoever to update these forward-looking-statements or to conform them to future events or developments.
Dotarem® and Lipiodol® are registered in the U.S. Patent and Trademark Office by Guerbet.
1 Data on File, Guerbet LLC
2 Altekruse et al. Hepatocellular Carcinoma Incidence, Mortality, and Survival Trends in the United States From 1975 to 2005. J Clin Oncol. 2009 March 20; 27(9): 14851491.
3 WHO Globocan 2012 (IARC) Section of Cancer Surveillance (9/7/2014).
4 Data on File, Guerbet LLC
SOURCE Guerbet LLC, USA
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