Gadobutrol

What it is and how it works

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.

Mechanism class: Magnetic Resonance Contrast Activity

Indications

Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): • To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates • To assess the presence and extent of malignant breast disease in adult patients • To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates • To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). . Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS) Gadobutrol injection is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients, including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

Dosage and administration (summary)

• Recommended dose for adults and pediatric patients (including term neonates) is 0.1 mL/kg body weight • Administer as an intravenous bolus injection • Follow injection with a normal saline flush Recommended Dose The recommended dose of gadobutrol injection for adult and pediatric patients (including term neonates) is 0.1 mL/kg body weight (0.1 mmol/kg). Refer to Table 1 to determine the volume to be administered.

Contraindications

Gadobutrol injection is contraindicated in patients with history of severe hypersensitivity reactions to gadobutrol injection. History of severe hypersensitivity reaction to gadobutrol injection

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. Monitor patients closely during and after administration of gadobutrol injection. • Acute Respiratory Distress Syndrome: For Patients demonstrating respiratory distress after administration, assess oxygen requirement and monitor for worsening respiratory function. • Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs.

Pregnancy

Pregnancy Risk Summary GBCAs cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data ) .

Storage and supply

How Supplied Gadobutrol injection is a sterile, clear and colorless to pale yellow solution containing 604.72 mg gadobutrol per mL (equivalent to 1 mmol gadobutrol) per mL. Gadobutrol injection is supplied in the following sizes: Product Code Unit of Sale Each 281202 NDC 65219-281-02 Packaged in a Box of 5 Cartons containing 3 vials each.

Source: Gadobutrol (Gadobutrol) — US FDA prescribing information, 2025-07-15, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.