gadofosveset (Discontinued)

Brand and Other Names:Ablavar
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 244mg/mL

MRI Contrast

MRI contrast agent for visualisation of abdominal or limb vessels

0.12 mL/kg (0.03 mmoL/kg) IV bolus

Administer over period up to 30 sec; follow by 25-30 mL NS flush; infusion rate not to exceed 1.5 mL/seconds

Safety and efficacy not established

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Interactions

Interaction Checker

and gadofosveset

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Pruritus (5%)

            Headache (4%)

            Nausea (4%)

            Paresthesia (3%)

            Vasodilation (3%)

            Anaphylaxis (2%)

            Dysgeusia

            Burning sensation

            <1%

            Coronary artery disease

            Prolonged QT interval

            Nephrogenic systemic fibrosis

            Hyperglycemia

            Gangrene

            Chest pain

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            Warnings

            Black Box Warnings

            Risk for nephrogenic systemic fibrosis (NSF) with acute or chronic renal insufficiency (GFR <30 mL/min/1.73 sq.m, hepatorenal syndrome, or acute renal insufficiency resulting from perioperative liver transplant

            NSF affects internal organs, skin, and muscle and can be fatal

            Only use if essential and MRI cannot not provide appropriate diagnostic image

            Screen for renal dysfunction, do not exceed recommended dosage, and allow for drug elimination before giving subsequent doses

            Contraindications

            Hypersensitivity to product or component of the formulation

            Cautions

            Renal insufficiency

            Asthma, allergic disorder, hypersensitivity; trained personnel and emergency resuscitative equipment must be available prior to and during administration

            Risk of nephrogenic systemic fibrosis (NSF) with severe renal impairment

            Screen patients for kidney disease before use and monitor renal function afterward; nephrogenic systemic fibrosis (NSF) associated with use of gadolinium contrast media in patients with kidney disease; do not exceed recommended dose

            Mild QT prolongation w/ elevated levels of gadofosveset (repeated use or overdose >0.05 mmoL/kg)

            QTc prolongation reported (rare)

            Elimination may occur faster in patients with hypoalbuminemia

            Use in patients with sickle cell anemia not studied

            Use caution in patients that have received iodine containing agents within 24 hr prior to gadofosveset

            Brain deposits

            • 7/28/2015: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for MRI
            • Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo ≥4 contrast MRI scans, long after the last administration
            • It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects
            • Early data in rat studies show that linear GBCAs are more prone to dissociation into free gadolinium and demonstrate greater brain deposition than macrocyclic GBCAs, which are less prone to dissociation
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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Excretion in milk unknown; use with caution

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.