"The US Food and Drug Administration (FDA) today approved the first nucleic acid-based test of cerebrospinal fluid (CSF) that can simultaneously detect 14 pathogens responsible for central nervous system (CNS) infections.
Instruct patients receiving VASOVIST (gadofosveset trisodium injection for intravenous use) Injection to inform their physician or healthcare provider if they:
- are pregnant or breast feeding
- have a history of allergic reaction to contrast media, a history of bronchial asthma or allergic respiratory disorder
- have a history of kidney and/or liver disease
- have recently received a gadolinium-based contrast agent
- have a history of heart rhythm disturbances, or cardiac disease
- are taking any prescription or over-the counter medications
Gadolinium-based contrast agents, including VASOVIST (gadofosveset trisodium injection for intravenous use) , increase the risk for NSF in patients with severe renal insufficiency or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative setting of liver transplantation.
Patients with less severe renal insufficiency who receive repetitive administrations of a gadolinium-based contrast agent may have an increased risk for the development of NSF, especially if the time interval between the administrations precludes clearance of the previously administered contrast agent from the body. If VASOVIST (gadofosveset trisodium injection for intravenous use) is administered in these situations, instruct patients to contact their physician or healthcare provider if they develop signs or symptoms of NSF, such as burning, itching, swelling, scaling, hardening and tightening of the skin, red or dark patches on the skin, stiffness in joints with trouble moving, bending or straightening of the arms, hands, legs, or feet, pain deep in the hip bones or ribs, or muscle weakness [see WARNINGS AND PRECAUTIONS].
Inform patients that they may experience:
- reactions at the injection site, such as: redness, mild and transient burning or pain or feeling of warmth or coldness
- side effects of itching or nausea
Last reviewed on RxList: 10/5/2009
This monograph has been modified to include the generic and brand name in many instances.
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