Magnevist
MAGNEVIST ®
(brand of gadopentetate dimeglumine) Injection
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
- Acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73m ), or
- 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 gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readminstration (See WARNINGS).
DRUG DESCRIPTION
MAGNEVIST ® (brand of gadopentetate dimeglumine) Injection is the N- methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI). MAGNEVIST Injection is provided as a sterile, clear, colorless to slightly yellow aqueous solution for intravenous injection.
MAGNEVIST Injection is a 0.5-mol/L solution of l-deoxy-l-(methylamino)-D-glucitol dihydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-glycinato-(5"-)-]gadolinate(2-)(2:1) with a molecular weight of 938, an empirical formula of C28H54GdN5O20, and has the following structural formula:
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Each mL of MAGNEVIST Injection contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine, 0.40 mg diethylenetriamine pentaacetic acid and water for injection. MAGNEVIST Injection contains no antimicrobial preservative.
MAGNEVIST Injection has a pH of 6.5 to 8.0. Pertinent physicochemical data are noted below:
PARAMETER
Osmolality (mOsmol/ kg water) at 37° C 1,960
Viscosity (CP) at 20° C 4.9
at
37° C 2.9
Density (g/mL) at 25° C 1.195
Specific gravity at 25° C 1.208
Octanol: H20 at 25° C and pH7 log Pow = - 5.4
MAGNEVIST Injection has an osmolality 6.9 times that of plasma which has an osmolality of 285 mOsmol/ kg water. MAGNEVIST Injection is hypertonic under conditions of use.
Generic Name: Gadopentetate Dimeglumine
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