VASOVIST Injection is a sterile, clear, colorless to pale yellow solution containing 244 mg/mL (0.25 mmol/mL) of gadofosveset trisodium in rubber-stoppered vials with an aluminum seal. VASOVIST Injection is supplied as follows:
- NDC 50419-310-01 — 10 mL fills in 10 mL single use vials packages of 10 vials
- NDC 50419-310-02 — 15 mL fills in 20 mL single use vials in packages of 10 vials
Store VASOVIST Injection at 25°C (77°F: excursions permitted to 15 to 30°C [59 to 86°F]). Protect from light and freezing.
Instruct patients receiving VASOVIST 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, 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 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 (5.1) ].
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
Distributed by Bayer Healthcare, Inc., Wayne, NJ
Co-Developed by EPIX Pharmaceuticals, Inc., Lexington, MA
US Patents: 7,060,250; 7,229,606; and 5,919,967
| VASOVIST |
gadofosveset trisodium injection
|Labeler — Bayer Healthcare, Inc.|
Revised: 01/2009 Bayer Healthcare, Inc.
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