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A total of 1309 subjects (24 healthy volunteers and 1285 patients) received OptiMARK™ (gadoversetamide injection) Injection and 46 subjects received placebo (saline). Of the 1309 subjects who received OptiMARK™ (gadoversetamide injection) Injection, 680 (52%) were men and 629 (48%) were women with a mean age of 50 years (range 12 to 85 years). In this population there were 1102 (84%) white, 116 (9%) black, 33 (3%) Asian, and 58 (4%) subjects and patients of other racial groups.
In the clinical trials there were 8 serious adverse events and 1 death. The one death occurred in a patient with advanced multisystem disease and appeared to be related to the underlying disease. Six of the eight serious events appeared to be related to underlying disease. Two patients had either persistent paresthesia or numbness of unknown etiology that required hospitalization for diagnostic evaluations or treatment.
Of the 1309 subjects, 460 (35%) reported at least one adverse event out of a total of 997 adverse events; and 22 (47.8%) of the 46 subjects who received placebo reported at least one adverse event out of a total of 81 adverse events.
The most commonly noted adverse events were headache (9.4%), vasodilatation (6.4%), taste perversion (6.2%), dizziness (3.7%), nausea (3.2%), and paresthesia (2.2%). All adverse events reported in 1% or greater of all patients are listed in Table 5. Of the subjects and patients who experienced adverse events, 95.8% of the adverse events were of mild or moderate intensity after dosing with OptiMARK™ (gadoversetamide injection) Injection.
Table 5: Summary Adverse Events Experienced by ≥ 1% of
|Body System or Event Type||OptiMARK™ (N = 1309)|
|Number of patients with one or more adverse events||460 (35.1%)|
|Total Number of Adverse Events||997|
|Patients with any injection associated discomfort||345 (26.4%)|
|Body as a Whole||193 (14.7%)|
|Pain Abdomen||24 (1.8%)|
|Pain Back||16 (1.2%)|
|Injection Site||35 (2.7%)|
|Injection Site Reaction||20 (1.5%)|
|Nervous System||109 (8.3%)|
|Skin and Appendages||37 (2.8%)|
|Special Senses||96 (7.3%)|
|Taste Perversion||81 (6.2%)|
The following adverse reactions occurred in less than 1% of the patients:
Skin and Appendages: application site reaction, edema injection site, erythema multiforme, pruritus, rash macular-papular and vesicullous bullous, skin dry, thrombophlebitis, inflammation injection site, urticaria
Post-marketing surveillance reports have identified cases of seizure.
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Drug interactions with other contrast agents and other drugs have not been studied.
Laboratory Test Interactions
Interference by OptiMARK™ (gadoversetamide injection) Injection in the measurement of serum iron, copper and zinc has been observed. OptiMARK™ (gadoversetamide injection) Injection causes interference in the measurement of serum calcium using the ortho-cresophthalin complexone (OCP) colorimetric method. In the presence of OptiMARK™ (gadoversetamide injection) Injection, OCP produces an erroneous, low value for serum calcium. The magnitude of this artifact is proportional to the concentration of OptiMARK™ (gadoversetamide injection) Injection in the blood, and accurate values can be obtained approximately 90 minutes following injection. In patients with renal insufficiency, clearance of OptiMARK™ (gadoversetamide injection) Injection is slowed and the interference with calcium determination by OCP is prolonged. Neither the arsenazo III dye system nor the inductively coupled plasma mass spectroscopy methods for calcium assay are affected by OptiMARK™ (gadoversetamide injection) Injection.
Last reviewed on RxList: 2/11/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional OptiMARK Information
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