GADOBUTROL

Diagnostic Agent

Brand names: Gadobutrol

Intravenous

Mechanism of Action

12.1 Mechanism of Action In MRI, visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with: • Differences in proton density • Differences of the spin-lattice or longitudinal relaxation times (T 1 ) • Differences in the spin-spin or transverse relaxation time (T 2 ) When placed in a magnetic field, gadobutrol shortens the T 1 and T 2 relaxation times. The extent of decrease of T 1 and T 2 relaxation times, and therefore the amount of signal enhancement obtained from gadobutrol, is based upon several factors including the concentration of gadobutrol in the tissue, the field strength of the MRI system, and the relative ratio of the longitudinal and transverse relaxation times. At the recommended dose, the T 1 shortening effect is observed with greatest sensitivity in T 1 -weighted magnetic resonance sequences. In T 2 *-weighted sequences the induction of local magnetic field inhomogeneities by the large magnetic m

Indications

including term neonates ( 1.3 ) • To assess myocardial perfusion (stress

including term neonates

to evaluate known or suspected supra-aortic or renal artery disease. 1.4 Cardiac MRI Gadobutrol injection is indicated for use in cardiac MRI (CMRI) to assess myocardial perfusion (stress

rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have occurred
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

8 documented side effects by frequency

Nausea

>10%

Vomiting

>10%

Itching

>10%

Shortness of Breath

1-10%

Dizziness

0.1-1%

Rash

0.1-1%

Cough

0.1-1%

Headache

0.1-1%

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Compare With

11 available comparisons

Formulations

Dosage Forms

Tablet

Route

Intravenous