Mallinckrodt Inc., a Covidien company, has changed the Optimark contrast agent label to contraindicate the product for use in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. We believe this action will help to reinforce the progress made to date in reducing the occurrence of NSF. Updated full prescribing information can be accessed at right. SEE UPDATED BOXED WARNING ABOVE.

Focused on Patients, Focused on Clinical Efficacy, Focused on Efficiency

Optimark gadoversetamide injection is the only gadolinium-based contrast agent (GBCA) approved for administration by a power injector by the U.S. Food and Drug Administration (FDA)¹. Convenient packaging options include our exclusive Ultraject™ prefilled syringes to help reduce the potential for medication errors, help meet stringent regulatory requirements, possibly reduce the risk of infection, and improve efficiency².

Optimark injection is a non-ionic, extracellular GBCA with roughly half the osmolality of the U.S. FDA-approved ionic GBCAs. It is also considered a lower viscosity GBCA which helps to facilitate the use of smaller caliber needles and lower pressures for patient administration.⁶

Optimark injection provides statistically significant improvement over baseline for conspicuity, border delineation, and confidence in number of lesions in Central Nervous System (CNS) and liver studies¹.

At Covidien we have made a commitment to help the physician community leverage medical innovation, information and insight to address patient care issues. We have established a specific email contact to address any questions as they pertain to NSF (nsfinformation@covidien.com) as well as provided links to pertinent information from both internal and external sources (on the right side of this page). We are committed to ongoing research, product innovation and professional education that results in enhanced patient care.

Important Safety Information

Optimark™ Injection (gadoversetamide injection) is contraindicated in patients at risk for nephrogenic systemic fibrosis (NSF). This includes 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. In these patients, avoid use of other gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced MRI. If a contrast-enhanced MRI is essential for a patient at risk for NSF, then a gadolinium-based contrast agent other than Optimark Injection should be used. For patients on hemodialysis, physicians may consider prompt initiation of hemodialysis after Optimark 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 Injection. The risks of use of Optimark contrast agent in patients with sickle cell anemia, hemolytic anemias and other hemoglobinopathies has not been studied. 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. Safety and effectiveness of Optimark Injection in pediatric patients have not been established. It is not recommended for use in children below the age of two years because the safety, efficacy and impact of immature kidney function have not studied in this age group. Optimark™ 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 BOXED WARNING AT TOP OF PAGE. Use link to package insert for full prescribing information.

¹Optimark [package insert]. Hazelwood, MO October 2009.

²2006 Comprehensive Accreditation Manual for Hospitals: The Official handbook. Oakbrook Terrace, IL; Joint Commission on Accreditation of Healthcare Organizations; 2006.

³Rohrer, M, et al., Comparison of Magnetic Properties of MRI Contrast Media Solutions at Different Field Strengths. Investigative Radiology 2005;40:715-724.

⁴Cochran, S, et al., Trends in Adverse Events after IV Administration of Contrast Media. American Journal of Radiology June 2001;176:1385-1388.

⁵Dawson, P. Textbook of Contrast Media, Chapters 22 and 23, 1999.

⁶Herts, BR, et al., Power Injection of Contrast Media Using Central Venous Catheters: Feasibility, Safety, and Efficacy. American Journal of Radiology 2001;176:447-453.

⁷Omniscan™ [package insert]. Princeton, NJ: GE Healthcare AS; June 2007.

⁸Prohance® [package insert]. Princeton, NJ: Bracco Diagnostics Inc.; May 2007

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.

¹²Femano, P. The Use of Prefilled Syringes in CT Contrast Administration: A Research Report. American Society of Radiologic Technologists 2001