"On Friday, May 27, the U.S. Food and Drug Administration granted accelerated approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an ina"...
Instruct patients receiving EOVIST to inform their physician or healthcare provider of the following:
- if they are pregnant or breast feeding
- if they have a previous history of allergic reaction to contrast media, a history of bronchial asthma or allergic respiratory disorder, or recent administration of a gadolinium based contrast agent
- if they have any history of kidney and/or liver disease
- of all medications they may be taking, including those taken without prescription
GBCAs increase the risk of NSF among patients with impaired elimination of drugs. To counsel patients at risk of NSF:
- Describe the clinical manifestation of NSF
- Describe procedures to screen for the detection of renal impairment
Instruct the patients to contact their physician if they develop signs or symptoms of NSF following EOVIST administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness. Inform patients that they may experience:
- reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site
- side effects of feeling hot, nausea, and headache
Last reviewed on RxList: 12/7/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Eovist Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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