Ablavar
ABLAVAR®
(gadofosveset trisodium) Injection
WARNING
NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
- The risk for NSF appears highest among patients with:
- chronic, severe kidney disease (GFR < 30 mL/min/1.73m²), or
- acute kidney injury.
- Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
- For patients at highest risk for NSF, do not exceed the recommended ABLAVAR (gadofosveset trisodium injection) dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration [see WARNINGS AND PRECAUTIONS].
DRUG DESCRIPTION
ABLAVAR (gadofosveset trisodium) Injection is a sterile, nonpyrogenic, formulation of a stable gadolinium diethylenetriaminepentaacetic acid (GdDTPA) chelate derivative with a diphenylcyclohexylphosphate group. Each mL of ABLAVAR Injection contains 244 mg of gadofosveset trisodium (0.25 mmol), 0.268 mg of fosveset, and water for injection.
It contains no preservative and the solution pH ranges between 6.5 and 8.0.
Gadofosveset trisodium is chemically trisodium-{(2-(R)-[(4,4-diphenylcyclohexyl) phosphonooxymethyl]diethylenetriaminepentaacetato)(aquo) gadolinium(III),with a molecular weight of 975.88 g/mol, and an empirical formula of C33H40GdN3Na3O15P. It has a structural formula:
 |
Pertinent physiochemical data of ABLAVAR (gadofosveset trisodium injection) Injection are provided below:
Table 3: Physiochemical Characteristics
| Parameter | Condition | Value |
| Osmolality (mOsmol/kg water) | @ 37° C | 825 |
| Viscosity (cP) | @ 20° C | 3.0 |
| Density (g/mL) | @ 25° C | 1.1224 |
Last reviewed on RxList: 2/9/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Ablavar Information
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