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Rho(D) immune globulin I.V.
WinRho SDF
Pharmaceutical company:
Baxter Healthcare Corporation
www.baxter.com
NEW WARNING
Cangene Corporation and Baxter Healthcare Corporation issued a “Dear Healthcare Professional” letter after cases of intravascular hemolysis (IVH) (and its complications) were reported when RhoD immune globulin I.V. (WinRho SDF) was prescribed for treatment of immune thrombocytopenic purpura (ITP). Some of the reported cases were fatal. In response, Cangene Corporation added a “Boxed Warning” to the prescribing information. The “Boxed Warning” warns of the risk for IVH leading to death in patients treated for ITP with WinRho. It warns that IVH can lead to clinically compromising anemia and multiple-organ-dysfunction syndrome, including acute respiratory distress syndrome. Moreover serious complications, such as severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation, may also occur.
Follow these precautions when administering WinRho:
* Monitor patients closely for at least 8 hours after WinRho administration.
* Perform a dipstick urinalysis at baseline and at 2 and 4 hours after administration, and then immediately before the monitoring period ends.
* Advise the patient to report signs and symptoms of IVH, including back pain, chills, fever, and discolored urine or hematuria.
* Obtain plasma hemoglobin, microscopic and dipstick urinalysis, haptoglobin, LDH, and bilirubin levels, if IVH is suspected.
For questions regarding WinRho use, contact Baxter Medical Affairs at 1-866-424-6724.
Brought to you by Lippincott Williams & Wilkins.
