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OptiMARK™
(gadoversetamide) Injection

For Intravenous Injection Only

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™ (gadoversetamide injection) 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™ (gadoversetamide injection) dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration (see WARNINGS).

DRUG DESCRIPTION

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.

Last reviewed on RxList: 2/11/2011
This monograph has been modified to include the generic and brand name in many instances.