Optiray™ 350
Optiray™ 320
Optiray™ 240

Optimark™ ,gadoversetamide injection

Important Safety Information

Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73m2) and in patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. For patients on hemodialysis, physicians may consider prompt initiation of hemodialysis after Optimark™ gadoversetamide injection MRI in order to enhance the contrast agent's elimination. Usefulness of hemodialysis in prevention of NSF is unknown. Among factors that may increase risk for NSF are repeated or higher than recommended doses of a gadolinium-based contrast agent and degree of renal function impairment at time of exposure. Do not exceed the recommended dose of Optimark™ gadoversetamide injection and allow sufficient time for elimination of the contrast agent before readministration. The risk, if any, for development of NSF among patients with mild to moderate renal insufficiency or normal renal function is unknown. The extent of risk for NSF following exposure to any specific gadolinium-based contrast agent is unknown and may vary among the agents. Contraindicated in patients with allergies or hypersensitivity to gadolinium or any other ingredients of Optimark™ gadoversetamide injection. The risks of use of Optimark™ contrast agent in patients with sickle cell anemia, hemolytic anemias and other hemoglobinopathies has not been studied. Since gadoversetamide is cleared renally, caution should be exercised in patients with impaired renal function. The possibility of a reaction, including serious, life threatening, fatal anaphylactoid or cardiovascular reactions or other idiosyncratic reactions should always be considered especially in those patients with a known clinical hypersensitivity, a history of asthma, or other respiratory disorders. In clinical studies, the most common adverse events were headache, vasodilation, taste perversion, dizziness, nausea and paresthesia. Postmarketing surveillance reports have identified cases of seizure. Optimark™ gadoversetamide injection should be administered as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual or by power injection. SEE BLACK BOX WARNING AT TOP OF PAGE. Use link to package insert for full prescribing information.

1Optimark™ [package insert]. Hazelwood, MO May 2007.

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9Magnevist® [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals, Inc., June 2007.

10MultiHance® [package insert]. Princeton, NJ: Bracco Diagnostics, Inc., May 2007.

11Eovist® [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals, Inc., 2008.

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