Gadavist

Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadavist is not approved for intrathecal use

GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Gadavist 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.

The risk for NSF appears highest among patients with:

• •Chronic, severe kidney disease (GFR < 30 mL/min/1.73m²), or
• •Acute kidney injury.

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.

For patients at highest risk for NSF, do not exceed the recommended Gadavist dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration

Warnings and Precautions, Acute Respiratory Distress Syndrome (5.4) 3/2025

Gadavist 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 (
  1.1 Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS)

  Gadavist 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.
  )
• •To assess the presence and extent of malignant breast disease in adult patients (
  1.2 MRI of the Breast

  Gadavist is indicated for use with MRI in adult patients to assess the presence and extent of malignant breast disease.
  )
• •To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates (
  1.3 Magnetic Resonance Angiography (MRA)

  Gadavist is indicated for use in magnetic resonance angiography (MRA) in adult and pediatric patients, including term neonates, to evaluate known or suspected supra-aortic or renal artery disease

  .
  )
• •To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). (
  1.4 Cardiac MRI

  Gadavist 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).
  ).

• •Recommended dose for adults and pediatric patients (including term neonates) is 0.1 mL/kg body weight (
  2.1 Recommended Dose

  The recommended dose of Gadavist 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.

  Table 1: Volume of Gadavist Injection by Body Weight*

  Body Weight (kg)	Volume to be Administered (mL)
  2.5	0.25
  5	0.5
  10	1
  15	1.5
  20	2
  25	2.5
  30	3
  35	3.5
  40	4
  45	4.5
  50	5
  60	6
  70	7
  80	8
  90	9
  100	10
  110	11
  120	12
  130	13
  140	14
  *for Cardiac MRI , the dose is divided into 2 separate, equal injections
  )
• •Administer as an intravenous bolus injection (
  2.2 Administration Guidelines

  • •Gadavist is formulated at a higher concentration (1 mmol/mL) compared to certain other gadolinium based contrast agents, resulting in a lower volume of administration. Use Table 1 to determine the volume to be administered.
  • •Use sterile technique when preparing and administering Gadavist.

  MRI of the Central Nervous System

  • •
    Administer Gadavist as an intravenous injection, manually or by power injector, at a flow rate of approximately 2 mL/second.
  • •
    Follow Gadavist injection with a normal saline flush to ensure complete administration of the contrast.
  • •
    Post contrast MRI can commence immediately following contrast administration.

  MRI of the Breast

  • •
    Administer Gadavist as an intravenous bolus by power injector, followed by a normal saline flush to ensure complete administration of the contrast.
  • •
    Start image acquisition following contrast administration and then repeat sequentially to determine peak intensity and wash-out
    .

  MR Angiography

  Image acquisition should coincide with peak arterial concentration, which varies among patients.

  Adults

  • •
    Administer Gadavist by power injector, at a flow rate of approximately 1.5 mL/second, followed by a 30 mL normal saline flush at the same rate to ensure complete administration of the contrast.

  Pediatric patients

  • •
    Administer Gadavist by power injector or manually, followed by a normal saline flush to ensure complete administration of the contrast.

  Cardiac MRI

  • •Administer Gadavist through a separate intravenous line in the contralateral arm if concomitantly providing a continuous infusion of a pharmacologic stress agent.
  • •Administer Gadavist as two (2) separate bolus injections: 0.05 mL/kg (0.05 mmol/kg) body weight at peak pharmacologic stress followed by 0.05 mL/kg (0.05 mmol/kg) body weight at rest.
  • •Administer Gadavist via a power injector at a flow rate of approximately 4 mL/second and follow each injection with a normal saline flush of 20 mL at the same flow rate.
  )
• •Follow injection with a normal saline flush (
  2.2 Administration Guidelines

  • •Gadavist is formulated at a higher concentration (1 mmol/mL) compared to certain other gadolinium based contrast agents, resulting in a lower volume of administration. Use Table 1 to determine the volume to be administered.
  • •Use sterile technique when preparing and administering Gadavist.

  MRI of the Central Nervous System

  • •
    Administer Gadavist as an intravenous injection, manually or by power injector, at a flow rate of approximately 2 mL/second.
  • •
    Follow Gadavist injection with a normal saline flush to ensure complete administration of the contrast.
  • •
    Post contrast MRI can commence immediately following contrast administration.

  MRI of the Breast

  • •
    Administer Gadavist as an intravenous bolus by power injector, followed by a normal saline flush to ensure complete administration of the contrast.
  • •
    Start image acquisition following contrast administration and then repeat sequentially to determine peak intensity and wash-out
    .

  MR Angiography

  Image acquisition should coincide with peak arterial concentration, which varies among patients.

  Adults

  • •
    Administer Gadavist by power injector, at a flow rate of approximately 1.5 mL/second, followed by a 30 mL normal saline flush at the same rate to ensure complete administration of the contrast.

  Pediatric patients

  • •
    Administer Gadavist by power injector or manually, followed by a normal saline flush to ensure complete administration of the contrast.

  Cardiac MRI

  • •Administer Gadavist through a separate intravenous line in the contralateral arm if concomitantly providing a continuous infusion of a pharmacologic stress agent.
  • •Administer Gadavist as two (2) separate bolus injections: 0.05 mL/kg (0.05 mmol/kg) body weight at peak pharmacologic stress followed by 0.05 mL/kg (0.05 mmol/kg) body weight at rest.
  • •Administer Gadavist via a power injector at a flow rate of approximately 4 mL/second and follow each injection with a normal saline flush of 20 mL at the same flow rate.
  )

Gadavist is a sterile, clear, and colorless to pale yellow solution for injection containing 604.72 mg gadobutrol per mL (equivalent to 1 mmol gadobutrol/mL) supplied in single-dose vials and pre-filled disposable syringes.