Vasovist

Indications
Dosage
How Supplied

INDICATIONS

VASOVIST (gadofosveset trisodium injection for intravenous use) is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Dosing Guidelines

Administer VASOVIST (gadofosveset trisodium injection for intravenous use) as an intravenous bolus injection, manually or by power injection, at a dose of 0.12 mL/kg body weight (0.03 mmol/kg) over a period of time up to 30 seconds followed by a 25-30 mL normal saline flush. (See Table 1 for weight-adjusted dose volumes).

TABLE 1: Weight-Adjusted Volumes for the 0.03 mmol/kg Dose

Body Weight Volume
Kilograms (kg) Pounds (lb) Milliliters (mL)
40 88 4.8
50 110 6.0
60 132 7.2
70 154 8.4
80 176 9.6
90 198 10.8
100 220 12.0
110 242 13.2
120 264 14.4
130 286 15.6
140 308 16.8
150 330 18.0
160 352 19.2

Inspect the VASOVIST (gadofosveset trisodium injection for intravenous use) vial visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present.

VASOVIST (gadofosveset trisodium injection for intravenous use) is intended for single use only and should be used immediately upon opening. Discard any unused portion of the VASOVIST (gadofosveset trisodium injection for intravenous use) vial.

Do not mix intravenous medications or parenteral nutrition solutions with VASOVIST (gadofosveset trisodium injection for intravenous use) . Do not administer any other medications in the same intravenous line simultaneously with VASOVIST (gadofosveset trisodium injection for intravenous use) .

Imaging Guidelines

VASOVIST (gadofosveset trisodium injection for intravenous use) imaging is completed in two stages: the dynamic imaging stage and the steady-state imaging stage. Both stages are essential for adequate evaluation of the arterial system, and dynamic imaging always precedes steady-state imaging. During interpretation of the steady-state images, VASOVIST (gadofosveset trisodium injection for intravenous use) within the venous system may limit or confound the detection of arterial lesions. To assess the initial distribution of VASOVIST (gadofosveset trisodium injection for intravenous use) within the arterial system, begin dynamic imaging immediately upon injection. Begin steady state imaging after dynamic imaging has been completed, generally 5 to 7 minutes following VASOVIST (gadofosveset trisodium injection for intravenous use) administration. At this time point, VASOVIST (gadofosveset trisodium injection for intravenous use) is generally distributed throughout the blood. In clinical trials, steady-state imaging was completed within approximately one hour following VASOVIST (gadofosveset trisodium injection for intravenous use) injection.

HOW SUPPLIED

Dosage Forms And Strengths

VASOVIST (gadofosveset trisodium injection for intravenous use) is a sterile solution for intravenous injection containing 244 mg/mL (0.25 mmol/mL) gadofosveset trisodium [see Storage and Handling]

Storage And Handling

VASOVIST (gadofosveset trisodium injection for intravenous use) Injection is a sterile, clear, colorless to pale yellow solution containing 244 mg/mL (0.25 mmol/mL) of gadofosveset trisodium in rubber-stoppered vials with an aluminum seal. VASOVIST (gadofosveset trisodium injection for intravenous use) Injection is supplied as follows:

NDC 50419-310-01 - 10 mL fills in 10 mL single use vials packages of 10 vials

NDC 50419-310-02 - 15 mL fills in 20 mL single use vials in packages of 10 vials

Store VASOVIST (gadofosveset trisodium injection for intravenous use) Injection at 25°C (77°F: excursions permitted to 15 to 30°C [59 to 86°F]). Protect from light and freezing.

Distributed by Bayer Healthcare, Inc., Wayne, NJ, Co-Developed by EPIX Pharmaceuticals, Inc., Lexington, MA.

Last reviewed on RxList: 10/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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