"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
PATIENT COUNSELING INFORMATION
Instruct patients to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath. Such symptoms may suggest kidney damage (see BOXED WARNING, WARNINGS and PRECAUTIONS).
Aseptic Meningitis Syndrome (AMS)
Instruct patients to immediately report signs and symptoms of AMS. These symptoms include severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting (see WARNINGS and PRECAUTIONS).
Instruct patients to immediately report signs and symptoms of hemolysis. These symptoms include fatigue, increased heart rate, yellowing of the skin or eyes, and dark-colored urine (see WARNINGS and PRECAUTIONS).
Transfusion-Related Acute Lung Injury (TRALI)
Instruct patients to immediately report signs and symptoms of TRALI, which is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. TRALI typically occurs within 1 to 6 hours following transfusion (see WARNINGS and PRECAUTIONS).
Transmissible Infectious Agents
Inform patients that Privigen™ is made from human plasma (part of the blood) and may contain infectious agents that can cause disease (e.g., viruses, and, theoretically, the CJD agent). Explain that the risk that Privigen™ (immune globulin intravenous) may transmit an infectious agent has been reduced by screening the plasma donors, by testing the donated plasma for certain virus infections, and by inactivating and/or removing certain viruses during manufacturing (see WARNINGS and PRECAUTIONS).
Live Virus Vaccines
Inform patients that administration of IgG may transiently impair the effectiveness of live virus vaccines (e.g., measles, mumps, and rubella) and to notify their immunizing physician of recent therapy with Privigen™ (see DRUG INTERACTIONS).
Last reviewed on RxList: 8/27/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Privigen 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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