Magnevist (Gadopentetate Dimeglumine) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

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Magnevist

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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 (gadopentetate dimeglumine) 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 (gadopentetate dimeglumine) 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® (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 (gadopentetate dimeglumine) Injection is provided as a sterile, clear, colorless to slightly yellow aqueous solution for intravenous injection.

MAGNEVIST (gadopentetate dimeglumine) 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® (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 (gadopentetate dimeglumine) Injection contains no antimicrobial preservative.

MAGNEVIST (gadopentetate dimeglumine) 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 at 25° C and pH7 log P_ow= - 5.4

MAGNEVIST (gadopentetate dimeglumine) Injection has an osmolality 6.9 times that of plasma which has an osmolality of 285 mOsmol/ kg water. MAGNEVIST (gadopentetate dimeglumine) 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 24 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 any of these serious side effects: