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Gadofosveset trisodium can cause a life-threatening condition in people with advanced kidney disease who are undergoing an MRI. The symptoms of this condition include:
Before receiving this medication, tell your doctor if you have kidney disease. You may not be able to receive an MRI with gadofosveset trisodium.
Before receiving gadofosveset trisodium, tell your doctor if you have ever had any type of reaction to another contrast agent, or if you have:
If you have any of these conditions, you may not be able to receive gadofosveset trisodium, or you may need a dose adjustment or special tests during treatment.
FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before you receive gadofosveset trisodium, tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether gadofosveset trisodium passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
Gadofosveset trisodium is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting during your MRA.
Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.
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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