WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
- Do not administer Optimark to patients with:
- chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or
- acute kidney injury (see CONTRAINDICATIONS).
- Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
- Do not exceed the recommended Optimark dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration (see WARNINGS).
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 certain medication errors, help meet a number of stringent Joint Commission requirements, toward single use, prelabeled containers and infection control measures, help reduce the risk of infection, and help 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 (email@example.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 (gadoversetamide injection) is contraindicated in patients with chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2) or acute kidney injury or known allergic or hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients. Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Report any diagnosis of NSF following Optimark administration to Mallinckrodt Inc. (1-800-778-7898) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch). 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. Pediatric patients may be particularly vulnerable to adverse GBCA reactions due to renal immaturity and/or unrecognized renal insufficiency. 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.