Ablavar

INDICATIONS

ABLAVAR 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 ABLAVAR 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 Milliliters (mL)
Kilograms (kg) Pounds (lb)
40 88 4.8
50 110 6
60 132 7.2
70 154 8.4
80 176 9.6
90 198 10.8
100 220 12
110 242 13.2
120 264 14.4
130 286 15.6
140 308 16.8
150 330 18
160 352 19.2

Inspect the ABLAVAR vial visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present.

ABLAVAR is intended for single use only and should be used immediately upon opening. Discard any unused portion of the ABLAVAR vial.

Do not mix intravenous medications or parenteral nutrition solutions with ABLAVAR. Do not administer any other medications in the same intravenous line simultaneously with ABLAVAR.

Imaging Guidelines

ABLAVAR 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, ABLAVAR within the venous system may limit or confound the detection of arterial lesions.

To assess the initial distribution of ABLAVAR 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 ABLAVAR administration. At this time point, ABLAVAR is generally distributed throughout the blood. In clinical trials, steady-state imaging was completed within approximately one hour following ABLAVAR injection.

HOW SUPPLIED

Dosage Forms And Strengths

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

Storage And Handling

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

NDC 11994-012-01 - 10 mL fills in 10 mL single use vials packages of 10 vials
NDC 11994-012-02 - 15 mL fills in 20 mL single use vials in packages of 10 vials

Store ABLAVAR Injection up to 25°C (77°F: excursions permitted to 15 to 30°C [59 to 86°F]). Protect from light and freezing.

Distributed by Lantheus Medical Imaging, Inc., 331 Treble Cove Road, North Billerica, MA 01862, United States. Revised: August 2013

Last reviewed on RxList: 8/23/2013
This monograph has been modified to include the generic and brand name in many instances.

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