Ablavar Generic Name & Formulations
Legal Class
Rx
General Description
Gadofosveset trisodium 244mg/mL (0.25mmol/mL); soln for IV inj.
Pharmacological Class
Gadolinium-based contrast agent.
How Supplied
Single-use vials (10mL, 15mL)—10
Manufacturer
Ablavar Indications
Indications
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.
Ablavar Dosage and Administration
Adult
Give as IV bolus inj over 30 seconds followed by 25–30mL normal saline flush. 0.12mL/kg (0.03mmol/kg). See full labeling for imaging guidelines.
Children
<18yrs: not established.
Ablavar Contraindications
Not Applicable
Ablavar Boxed Warnings
Not Applicable
Ablavar Warnings/Precautions
Warnings/Precautions
Chronic, severe kidney disease (GFR<30mL/min/1.73m2), acute kidney injury: increased risk of nephrogenic systemic fibrosis; avoid unless necessary, allow sufficient period of time for elimination prior to re-administration. Screen for acute kidney injury and other conditions that reduce renal function (eg, >60yrs, hypertension, diabetes). Anaphylactoid reaction possible (may be fatal); discontinue immediately if occurs; have emergency resuscitative equipment available. History of drug reactions, asthma, allergy or other hypersensitivity disorders. Risk of QTc prolongation; consider obtaining baseline ECG to assess risk, consider follow up ECG and risk reduction measures until contrast agent eliminated. Pregnancy (Cat.C). Nursing mothers.
Ablavar Pharmacokinetics
See Literature
Ablavar Interactions
Interactions
Caution with concomitant drugs that bind to albumin.
Ablavar Adverse Reactions
Adverse Reactions
Pruritus, headache, nausea, vasodilation, paresthesia, inj site bruising, dysgeusia, burning sensation, venipuncture site bruise, hypertension, dizziness, feeling cold; hypersensitivity reactions.
Ablavar Clinical Trials
See Literature
Ablavar Note
Not Applicable
Ablavar Patient Counseling
See Literature