Gadavist

— THERAPEUTIC CATEGORIES —
  • Imaging agents
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Gadavist Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Gadobutrol 604.72mg/mL (1mmol/mL); soln for IV inj; preservative-free.

    Pharmacological Class

    Gadolinium-based contrast agent.

    How Supplied

    Single-dose vials (2mL)—15; (7.5mL, 10mL, 15mL)—20; Single-use prefilled syringes (7.5mL, 10mL, 15mL)—5

    Storage

    Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).

    Should freezing occur, Gadavist should be brought to room temperature before use. If allowed to stand at room temperature, Gadavist should return to a clear and colorless to pale yellow solution.

    Manufacturer

    Bayer Corporation

    Generic Availability

    NO

    Mechanism of Action

    When placed in a magnetic field, Gadavist shortens the T1 and T2 relaxation times. The extent of decrease of T1 and T2 relaxation times, and therefore the amount of signal enhancement obtained from Gadavist, is based upon several factors including the concentration of Gadavist in the tissue, the field strength of the MRI system, and the relative ratio of the longitudinal and transverse relaxation times.

    Gadavist Indications

    Indications

    For use in MRI of the CNS in adults and children (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity. MRI of the breast to assess the presence and extent of malignant breast disease. For use in magnetic resonance angiography (MRA) in adults and children (including term neonates) to evaluate known or suspected supra-aortic or renal artery disease. For use in cardiac MRI to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adults with known or suspected coronary artery disease.

    Gadavist Dosage and Administration

    Adults and Children

    Preterm neonates: not established. Give by IV inj manually or by power injector (see full labeling). 0.1mL/kg (0.1mmol/kg), followed by a normal saline flush to ensure complete injection. MRI of CNS: at a rate of ~2mL/sec. MRA (adults): at a rate of ~1.5mL/sec, followed by 30mL saline flush at the same rate; (peds): follow dose with a normal saline flush. Cardiac MRI (give as two bolus injections): 0.05mL/kg (0.05mmol/kg) at peak pharmacologic stress, followed by 0.05mL/kg at rest via a power injector at a rate of ~4mL/sec, followed by 20mL saline flush for each inj at the same rate. Administer in the contralateral arm through a separate IV line if concomitant continuous infusion of a stress agent.

    Gadavist Contraindications

    Not Applicable

    Gadavist Boxed Warnings

    Boxed Warning

    Risk associated with intrathecal use. Nephrogenic systemic fibrosis.

    Gadavist Warnings/Precautions

    Warnings/Precautions

    Not approved for intrathecal use. Increased risk of nephrogenic systemic fibrosis in chronic kidney disease or acute kidney injury; avoid use. Screen for renal dysfunction. Do not exceed recommended dose and allow sufficient time for drug elimination before re-administration. Have emergency resuscitative equipment available. History of asthma or other allergic disorders. Monitor for hypersensitivity reactions during and after administration. Increased risk of gadolinium retention with multiple lifetime doses, in pregnant patients, children, and those with inflammatory conditions; minimize repetitive imaging studies. Gadavist MRI may overestimate extent of malignancy in the diseased breast up to 50% of patients. Low sensitivity for significant arterial stenosis. Avoid extravasation. Elderly. Pregnancy. Nursing mothers.

    Gadavist Pharmacokinetics

    Elimination

    Renal. Half-life: 1.8 hours (adults).

    Gadavist Interactions

    Interactions

    Do not mix with other medications or administer in same IV line simultaneously.

    Gadavist Adverse Reactions

    Adverse Reactions

    Headache, nausea, dizziness; hypersensitivity reactions.

    Gadavist Clinical Trials

    See Literature

    Gadavist Note

    Not Applicable

    Gadavist Patient Counseling

    See Literature

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