Drug Detail:Gadavist (Gadobutrol [ gad-oh-bue-trol ])
Generic Name: GADOBUTROL 604.72mg in 1mL
Dosage Form: injection
Drug Class: Magnetic resonance imaging contrast media
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.
|
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 |
|
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.
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.
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.
- •
- Instructions of the device manufacturer must be followed.
Pharmacy Bulk Package Preparation
- •
- Pharmacy Bulk Packages are not for use in direct intravenous infusions.
- •
- After the Pharmacy Bulk Package has been opened, Gadavist remains stable for 24 hours at 20–25°C (68–77°F).
- •
- The Pharmacy Bulk Package contains many single doses and is used with an appropriate transfer device for filling empty sterile syringes.
- •
- The transfer of Gadavist from the Pharmacy Bulk Package must be performed in an aseptic work area, such as a laminar flow hood, using aseptic technique.
- •
- Once the Pharmacy Bulk Package is punctured, it should not be removed from the aseptic work area during the entire 24 hour period of use.
- •
- IV tubing and syringes used to administer Gadavist must be discarded at the conclusion of the radiological examination.
The contents of the Pharmacy Bulk Package after initial puncture should be used within 24 hours. Discard any unused portion in accordance with regulations dealing with the disposal of such materials.
