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Magnevist

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Magnevist

MAGNEVIST®
(gadopentetate dimeglumine) Injection

WARNING

NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

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 MAGNEVIST 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 (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

Do not exceed the recommended MAGNEVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration (see WARNINGS AND PRECAUTIONS).

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 1-deoxy-1-(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:

MAGNEVIST® (brand of gadopentetate dimeglumine) Structural Formula Illustration

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: H2O Coefficient at 25° C, 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.

What are the possible side effects of gadopentetate dimeglumine (Magnevist)?

Some of the side effects of gadopentetate dimeglumine can occur up to 48 hours after you have received the medication.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite;
  • swelling, weight gain, feeling short of breath; or
  • swelling,...

Read All Potential Side Effects and See Pictures of Magnevist »

Last reviewed on RxList: 4/11/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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