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Gadavist
gadobutrol
Black Box Warnings .
Risk with Inadvertent Intrathecal Administration
not approved for intrathecal use; intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, seizures
Nephrogenic Systemic Fibrosis
may result in fatal or debilitating fibrosis affecting skin, muscle, internal organs; avoid gadolinium-based contrast agents (GBCAs) in patients with impaired elimination of drugs, unless diagnostic info is essential and not available with non-contrasted MRI or other modalities; highest risk in patients with eGFR <30 or acute kidney injury; screen patients for acute kidney injury or other conditions that may reduce renal function; estimate GFR if patients at risk for chronically reduced renal function, including patients >60 yo and patients with HTN or diabetes; do not exceed recommended dose, allow sufficient time for drug elimination before re-administering in highest-risk patients; report any diagnosis of nephrogenic systemic fibrosis to Bayer Healthcare at 1-888-842-2937 or FDA at 1-800-FDA-1088
Adult Dosing .
Dosage forms: INJ
magnetic resonance imaging
- [CNS]
- Dose: 0.1 mL/kg/dose IV x1
- [breast]
- Dose: 0.1 mL/kg/dose IV x1
- [cardiac]
- Dose: 0.05 mL/kg/dose IV x1 at peak pharmacologic stress, then 0.05 mL/kg/dose IV x1 at rest
magnetic resonance angiography
- [0.1 mL/kg/dose IV x1]
- Info: for patients with known or suspected supra-aortic or renal artery disease
renal dosing
- [see below]
- renal impairment: no adjustment
- HD: no adjustment, on dialysis days consider administering right before dialysis; no supplement; PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
magnetic resonance imaging, CNS
- [full-term neonates and older]
- Dose: 0.1 mL/kg/dose IV x1
magnetic resonance angiography
- [full-term neonates and older]
- Dose: 0.1 mL/kg/dose IV x1; Info: for patients with known or suspected supra-aortic or renal artery disease
renal dosing
- [see below]
- renal impairment: no adjustment
- HD: no adjustment, on dialysis days consider administering right before dialysis; no supplement; PD: not defined
hepatic dosing
- [not defined]