Guerbet announced that Novation has awarded a new agreement for Dotarem (gadoterate meglumine) injection.
Dotarem injection is a gadolinium-based contrast agent 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.
The agreement, effective November 1, 2013, was awarded through Novation's competitive innovative technology program which seeks to identify and contract for innovative products that are used in clinical care and offer an incremental benefit to the care and safety of a patient and health care worker.
Dotarem - which has been commercialized widely throughout the world since 1989 and with more than 42 million doses administered outside the US - is the only macrocyclic and ionic GBCA, the company claims.
The recommended dose is 0.2ml/kg (0.1mmol/kg) body weight (BW).
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.
Guerbet US general manager Massimo Carrara said: "We are very pleased to have been selected through Novation's new technology process and are eager to provide the broad range of members served by Novation an alternative like Dotarem, the first and only FDA approved macrocyclic and ionic GBCA."
The most common adverse reactions associated with Dotarem in clinical studies were nausea, headache, injection site pain, injection site coldness, and burning sensation.
