Omniscan Special Precautions

Hypersensitivity: The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions or other idiosyncratic reactions should always be considered, especially in those patients with a known clinical hypersensitivity or a history of asthma or other allergic respiratory disorders.
Intrathecal administration: OMNISCAN must not be used intrathecally. Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures.
Patients with renal impairment: Prior to administration of OMNISCAN, all patients should be screened for renal dysfunction by obtaining laboratory tests.
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of OMNISCAN (gadodiamide) and other gadolinium-containing contrast agents in patients with chronic severe renal impairment and/or acute kidney injury.
OMNISCAN is contraindicated in these patients. The risk, if any, for the development of NSF among patients with moderate renal insufficiency is unknown.
Because of the lack of information on repeated administration, OMNISCAN injections should not be repeated unless the interval between injections is at least 7 days.
Gadolinium retention: Trace amounts of Gadolinium may be retained in the brain (particularly in the dentate nucleus and globus pallidus), and in other tissues for months to years after administration of GBCAs. Higher concentrations have been identified in human bone than in skin and brain. Nonclinical evidence suggests that the level of gadolinium retention is higher after repeat administration of linear than after repeat administration of macrocyclic agents.
Increased signal intensity on non-contrast T1 weighted images of the brain has been observed after multiple administrations of GBCAs even in patients with normal renal function. The clinical significance of gadolinium retention in brain is unknown.
There are rare reports of pathologic skin changes including gadolinium associated plaques in patients with normal renal function. Post marketing reports of adverse events involving multiple organ systems in patients with normal renal function have been received. A causal link to gadolinium retention has not been established. These events include fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems.
While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and paediatric patients.
In order to minimize potential risks associated with gadolinium retention, it is recommended to use the lowest effective dose and to perform a careful benefit risk assessment before administering repeated doses.
Patients with central nervous system disorders: In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased. Precautions are necessary when examining these patients (e.g. monitoring of the patient) and the equipment and medicinal products needed for the rapid treatment of possible convulsions should be available.
OMNISCAN interferes with serum calcium measurements with some colorimetric complexometric methods commonly used in hospitals. Thus, it is recommended not to use such methods for 12-24 hours after administration of OMNISCAN. If such measurements are necessary, the use of other methods is recommended.
Effects on ability to drive and use machines: None known.
Use in Children: Neonates and infants: OMNISCAN is contraindicated in neonates up to 4 weeks of age. Due to immature renal function in infants up to 1 year of age, OMNISCAN should only be used in these patients after careful consideration.
Paediatric patients: Gadolinium is retained in paediatric brains similar in amount and distribution to adults. Developing paediatric brains may be more susceptible to the potential effects of gadolinium exposure.