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:

ABLAVAR® (gadofosveset trisodium) Structural Formula Illustration

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

What are the possible side effects of gadofosveset trisodium (Ablavar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite;
  • swelling, weight gain, feeling short of breath; or
  • fast, uneven heart rate.

Less serious side effects may include:

  • mild itching;
  • headache, dizziness;
  • nausea,...

Read All Potential Side Effects and See Pictures of Ablavar »

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

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.