OptiMARK™ (gadoversetamide injection) is a formulation of a nonionic gadolinium chelate of diethylenetriamine pentaacetic acid bismethoxyethylamide (gadoversetamide), for use in magnetic resonance imaging (MRI). OptiMARK™ (gadoversetamide injection) Injection is to be administered by intravenous injection only.

OptiMARK™ (gadoversetamide injection) Injection is provided as a sterile, nonpyrogenic, clear, colorless to pale yellow, aqueous solution of gadoversetamide. No preservative is added. Each mL of OptiMARK™ Injection contains 330.9 mg of gadoversetamide (0.5 millimole), 28.4 mg of calcium versetamide sodium (0.05 millimole), 0.7 mg calcium chloride dihydrate (0.005 millimole), and water for injection. Sodium hydroxide and/or hydrochloric acid may have been added for pH adjustment.

OptiMARK™ (gadoversetamide injection) Injection is designated chemically as [8, 11-bis(carboxymethyl)-14-[2-[(2methoxyethyl)amino]-2-oxoethyl]-6-oxo-2-oxa-5,8,11,14-tetraazahexadecan-16-oato(3-)] gadolinium with a formula weight of 661.77 g/mol and empirical formula of C20H34N5O10Gd. The structural formula of gadoversetamide in aqueous solution is:

OptiMARK™ 0.5 mmol/mL (Gadoversetamide) Structural Formula Illustration

OptiMARK™ (gadoversetamide injection) Injection has a pH of 5.5 to 7.5 and pertinent physiochemical data are provided below:

Table 1: Physiochemical Data

Osmolality (mOsmol/kg water) @ 37°C 1110
Viscosity (cP) @ 20°C 3.1
@ 37°C 2.0
Density (g/mL) @ 25°C 1.160

OptiMARK™ (gadoversetamide injection) Injection has an osmolality of approximately 3.9 times that of plasma (285 mOsm/kg water) and is hypertonic under conditions of use.

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