GADOBENATE DIMEGLUMINE

Other

Brand names: MultiHance

Intravenous

Mechanism of Action

12.1 Mechanism of Action Gadobenate dimeglumine is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The large magnetic moment produced by the paramagnetic agent results in a large local magnetic field, which can enhance the relaxation rates of water protons in its vicinity leading to an increase of signal intensity (brightness) of tissue. In magnetic resonance imaging (MRI), visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occur with 1) differences in proton density; 2) differences of the spin-lattice or longitudinal relaxation times (T1); and 3) differences in the spin-spin or transverse relaxation time (T2). When placed in a magnetic field, gadobenate dimeglumine decreases the T1 and T2 relaxation time in target tissues. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.

Indications

1 INDICATIONS AND USAGE magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates)

to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain

spine

to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain

spine

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hypersensitivity: anaphylactic/anaphylactoid reactions with cardiovascular, respiratory and cutaneous manifestations, ranging from mild to severe reactions including shock can occur
1 Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures
2 Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs
The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing

Known Side Effects

7 documented side effects by frequency

Nausea

1-10%

Vomiting

1-10%

Anxiety

1-10%

Shortness of Breath

1-10%

Itching

1-10%

Joint Pain

0.1-1%

Tingling/Numbness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous