July 7, 2015

Gadavist




Indications
Dosage
How Supplied

INDICATIONS

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 (BBB) and/or abnormal vascularity of the central nervous system.

MRI Of The Breast

Gadavist is indicated for use with MRI to assess the presence and extent of malignant breast disease.

DOSAGE AND ADMINISTRATION

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 Volume to be Administered, mL
lb kg
5.5 2.5 0.25
11 5 0.5
22 10 1
33 15 1.5
44 20 2
55 25 2.5
66 30 3
77 35 3.5
88 40 4
99 45 4.5
110 50 5
132 60 6
154 70 7
176 80 8
198 90 9
220 100 10
242 110 11
264 120 12
286 130 13
308 140 14

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. Closely examine Table 1 to determine the volume to be administered.
  • Use sterile technique when preparing and administering Gadavist.
  • Administer Gadavist as an intravenous bolus 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.
  • Contrast-enhanced MRI can commence immediately following contrast administration.

Drug Handling

  • Visually inspect Gadavist for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, if particulate matter is present or if the container appears damaged.
  • Do not mix Gadavist with other medications and do not administer Gadavist in the same intravenous line simultaneously with other medications because of the potential for chemical incompatibility.
Vials
  • Draw Gadavist into the syringe immediately before use.
  • Do not pierce the rubber stopper more than once. Discard any unused vial contents.
Pre-filled syringes
  • Remove the tip cap from the pre-filled syringe immediately before use. Discard any unused syringe contents.

HOW SUPPLIED

Dosage Forms And Strengths

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.

Gadavist is a sterile, clear and colorless to pale yellow solution containing 604.72 mg gadobutrol per mL (equivalent to 1 mmol gadobutrol) per mL. Gadavist is supplied in the following sizes:

Single-Dose Vials

2 mL single-dose vials, rubber stoppered in cartons of 3, Boxes of 15 (NDC 50419-325-37)
7.5 mL single-dose vials, rubber stoppered in cartons of 10, Boxes of 20 (NDC 50419-325-11)
10 mL single-dose vials, rubber stoppered, in cartons of 10, Boxes of 20 (NDC 50419-325-12)
15 mL single-dose vials, rubber stoppered, in cartons of 10, Boxes of 20 (NDC 50419-325-13)

Single-Dose Pre-Filled Syringes

7.5 mL single-dose pre-filled disposable syringes, Boxes of 5 (NDC 50419-325-27)
10 mL single-dose pre-filled disposable syringes, Boxes of 5 (NDC 50419-325-28)
15 mL single-dose pre-filled disposable syringes, Boxes of 5 (NDC 50419-325-29)

Storage And Handling

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Should freezing occur, Gadavist should be brought to room temperature before use. If allowed to stand at room temperature, Gadavist should return to a clear and colorless to pale yellow solution. Visually inspect Gadavist for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, if particulate matter is present or if the container appears damaged.

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981. Revised: December 2014

Last reviewed on RxList: 1/15/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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