ABLAVAR® - Product and Prescribing Information

Download the full ABLAVAR^® Prescribing Information, including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF).

ABLAVAR® Prescribing Information

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.

CONTRAINDICATIONS:

History of a prior allergic reaction to a gadolinium-based contrast agent.

IMPORTANT SAFETY INFORMATION:

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 dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.

ABLAVAR^® Injection: As with other contrast media, the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered. As with other gadolinium based contrast agents, caution should be exercised in patients with renal insufficiency due to the possibility of further deterioration in renal function.

In clinical trials, a small increase (2.8 msec) in the average change from baseline in QTc was observed at 45 minutes following ABLAVAR^® administration. These QTc prolongations were not associated with arrhythmias or symptoms. Caution should be used in patients at high risk for arrhythmias due to baseline QTc prolongation.

Have emergency resuscitative equipment available prior to and during ABLAVAR^® administration.

Please see full Prescribing Information, including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF).