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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
Manufacturer
Generic Availability
NO
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
Nephrogenic systemic fibrosis.
Gadavist Warnings/Precautions
Warnings/Precautions
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 signs/symptoms of 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
See Literature
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
