Gadavist

Indications
Dosage
How Supplied

INDICATIONS

Gadavist (gadobutrol) is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

DOSAGE AND ADMINISTRATION

Gadavist (gadobutrol) 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 the table below to determine the volume to be administered.

Adults and Children (2 years and older)

The recommended dose of Gadavist (gadobutrol) is 0.1 mL/kg body weight (0.1 mmol/kg).

VOLUME OF GADAVIST (gadobutrol) INJECTION BY BODY WEIGHT

BODY WEIGHT Volume to be administered, mL
Ib kg
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
298 140 14

  • Visually inspect Gadavist (gadobutrol) 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.
  • Administer Gadavist (gadobutrol) as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second. Flush the intravenous cannula with physiological saline solution after the injection.

Dosing Guidelines

  • Sterile technique must always be used when preparing and administering injection of contrast media. Do not mix Gadavist (gadobutrol) with other drugs.
  • Contrast-enhanced MRI can commence immediately following contrast administration.
Vials
  • Draw Gadavist (gadobutrol) into the syringe immediately before use.
  • Do not pierce the rubber stopper more than once. Discard any unused vial contents.
Pre-fllled 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 (gadobutrol) is a sterile, clear, colorless to pale yellow solution for injection containing 1 mmol gadobutrol per milliliter (equivalent to 604.72 mg gadobutrol/mL).

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

Single-Dose Vials

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 (gadobutrol) should be brought to room temperature before use. If allowed to stand at room temperature, Gadavist (gadobutrol) should return to a clear, colorless to pale yellow solution. Visually inspect Gadavist (gadobutrol) 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, Wayne, NJ 07470. Manufactured in Germany. Revised: March 2011

Last reviewed on RxList: 5/5/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.