Vasovist

Vasovist Patient Information including How Should I Take

What should I discuss with my health care provider before receiving gadofosveset trisodium (Vasovist)?

Gadofosveset trisodium can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:

  • burning, itching, swelling, scaling, and tightening or hardening of your skin;
  • muscle weakness;
  • joint stiffness in your arms, hands, legs, or feet;
  • deep bone pain in your ribs or your hips;
  • trouble moving; or
  • skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadofosveset trisodium.

To make sure you can safely receive this medication, tell your doctor if you have any of these other conditions:

  • diabetes;
  • high blood pressure;
  • liver disease (or liver transplant);
  • a heart rhythm disorder;
  • a personal or family history of "Long QT Syndrome";
  • asthma, hay fever, or a history of food or drug allergies;
  • if you are over 60 years old;
  • if you have ever had any type of reaction to a contrast agent; or
  • if you have recently had an injury, surgery, or severe infection.

FDA pregnancy category C. It is not known whether gadofosveset trisodium will harm an unborn baby. Before you receive this medication, tell your doctor if you are pregnant.

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.

How is gadofosveset trisodium given (Vasovist)?

Gadofosveset trisodium is injected into a vein through an IV. 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.

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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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