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Table 1 Current FDA approved GBCAs

From: Gadolinium-enhanced cardiovascular magnetic resonance: administered dose in relationship to united states food and drug administration (FDA) guidelines

Contrast agent

Trade name

Manufacture

Label dose

Age

FDA Approved indication

Gadopentetate Dimeglumine (Gd-DTPA2)

Magnevist®

Bayer Healthcare

0.1 mmol/Kg (0.2 mL/Kg)

2 years and older

Central Nervous System*

Extracranial/Extraspinal Tissues**

Body (excluding the heart)***

Gadodiamide (Gd-DTPA-BMA)

Omniscan®

GE Healthcare

0.1 mmol/Kg (0.2 mL/Kg)

0.05 mmol/Kg (0.1 mL/Kg)§

2-16 years and adults

Central Nervous System*

Body [noncardiac]****

Gadoversetamide (Gd-DTPA-BMEA)

OptiMark®

Mallinckrodt

0.1 mmol/Kg (0.2 mL/Kg)

18 to 76 years

Central Nervous System*

Liver

Gadoteridol

ProHance®

Bracco Diagnostics

0.1 mmol/Kg (0.2 mL/Kg)

Additional dose of 0.2 mmol/Kg (0.4 mL/Kg) §§§

2 - 18 years and adults

Central Nervous System*

Extracranial/Extraspinal Tissues**

Gadobenate Dimeglumine (Gd-BOPTA)

MultiHance®

Bracco Diagnostics

0.1 mmol/Kg (0.2 mL/Kg)

2 years and older

Central Nervous System*

Gadobutrol (Gd-DO3A-butrol)

Gadavist®

Gadovist®;§§

Bayer Healthcare

0.1 mmol/Kg (0.1 mL/Kg)

2 years and older

Disrupted Blood Brain Barrier

Central Nervous System*

Gadofosveset trisodium

Ablavar®

Vasovist®§§

Lantheus Medcl

0.03 mmol/Kg (0.12 mL/Kg)

Adults

Aortoiliac occlusive disease

Gadoxetate disodium

Eovist®

Primovist®§§

Bayer Healthcare

0.025 mmol/Kg (0.1 mL/Kg)

Adults

Liver Lesions

Outside the US only, shown for completeness

     

Gadoterate Meglumine (Gd-HP-DOTA)

Dotarem ®

Artirem ® §§

Guerbet

0.1 mmol/Kg (0.2 mL/Kg)

2 years and older

Central Nervous System*

Body [noncardiac]****

  1. Other agents previously approved but not currently available are Mangafodipir Trisodium (Teslascan®; GE Healthcare) and Ferumoxides (Feridex®; Amag Pharms). NDA, New Drug Application. * Abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. ** Abnormal vascularity in the head and neck. *** Abnormal vascularity in the body. **** Intrathoracic, abdominal, pelvic cavities, and the retroperitoneal space. § For Kidney studies. §§ Only for use outside the United States. §§§ May be given up to 30 minutes after the first dose for patients with normal renal function suspected of having poorly enhancing central Nervous System lesions.