Gadavist

GADAVIST- gadobutrol injection
Bayer HealthCare Pharmaceuticals Inc.

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs 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 [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

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.

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.

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.

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).

2 DOSAGE AND ADMINISTRATION

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

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.

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