Rho(D) immune globulin intravenous (WinRho SDF) has received a boxed warning related to patients dying from intravascular hemorrhage (IVH) in those who have been administered this agent for managing immune thrombocytopenia purpura.15 Additional serious complications have occurred with the use of this product, including severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation. Deaths have been reported most frequently in patients over age 65 years and with co-morbid conditions.16 The boxed warning informs healthcare professionals to closely monitor patients in a healthcare setting for at least eight hours after administration and perform a urinalysis (e.g., dipstick) at baseline, at two hours and four hours after administration, and prior to the end of the monitoring period. In addition, patients should be alerted to and monitored for signs and symptoms of IVH (e.g., back pain, shaking chills, fever, discolored urine, hematuria). Even if these signs or symptoms do not occur within eight hours of receiving WinRho, they can subsequently occur. If IVH is suspected after administering WinRho, post-treatment laboratory testing should be performed, including plasma hemoglobin, urinalysis, haptoglobin, lactate dehydrogenase, and plasma direct and indirect bilirubin.
Explore This IssueMay 2010
Also By This Author
A draft guidance from the National Institute for Health and Clinical Excellence (NICE)—an independent advisory groups to the National Health Service in the U.K.—recommends use of rituximab (MabThera) in combination with MTX in patients who do not respond to other therapies, including at least one TNF inhibitor. Additionally, NICE also stated that use of a second TNF inhibitor following failure of a first TNF inhibitor should only be done within the confines of a clinical trial, and that abatacept should not be used in patients with RA that have failed treatment with a TNF inhibitor. The committee does not consider abatacept to be a better therapy than rituximab. They also feel that abatacept is not a good value for the money, considering that it is also more costly.17
Dr. Kaufman is a freelance medical writer based in New York City and a Clinical Pharmacist at New York Downtown Hospital.
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- Covidien launches generic version of Actiq. www.ajc.com/business/covidien-launches-generic-version-344323.html?cxntlid=daylf_artr. Published March 3, 2010. Accessed March 17, 2010.
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- FDA classifies Prolia (Denosumab) complete response submission and targets action date. www.amgen.com/media/media_pr_detail.jsp?year=2010&releaseID=1393314. Published February 19, 2010. Accessed March 17, 2010.
- Zogenix initiates pivotal phase 3 clinical trial for novel formulation of oral controlled-release hydrocodone. www.zogenix.com/index.php/news/zogenix-initiates-pivotal-phase-3-clinical-trial-for-novel-formulation-of-oral-controlled-release-hydrocodone/. Published March 17, 2010. Accessed March 17, 2010.
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- Dennis M. Roche, Biogen Idec suspends ocrelizumab treatment in rheumatoid arthritis trials. www.firstwordplus.com/Fws.do?articleid=49796805EE5B4BB4A3E56F64ABBEAA9D&logRowId=354200. Published March 8, 2010. Accessed March 17, 2010.
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- Dane L. FDA panel recommends approval for InterMune’s Esbriet. www.firstwordplus.com/Fws.do?articleid=DF0CC2FCF3D24EDDBE2A1EEE7994842D&logRowId=354313. Published March 9, 2010. Accessed March 17, 2010.
- Jazz Pharmaceuticals announces FDA acceptance of its new drug application for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. http://investor.jazzpharma.com/phoenix.zhtml?c=210227&p=irol-newsArticle_print&ID=1392820&highlight=. Published February 18, 2010. Accessed March 17, 2010.
- NDA submitted for extended-release tapentadol tablets for chronic pain. www.empr.com/nda-submitted-for-extended-release-tapentadol-tablets-for-chronic-pain/article/158882. Published December 2, 2009. Accessed March 17, 2010.
- Genentech submits supplemental Biologics License Application for ACTEMRA (tocilizumab) for prevention of structural joint damage and improvement of physical function in rheumatoid arthritis. www.gene.com/gene/news/press-releases/display.do?method=detail&id=12687. Published March 16, 2010. Accessed March 17, 2010.
- Oral bisphosphonates: Ongoing safety review of atypical subtrochanteric femur fractures. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204127.htm. Published March 10, 2010. Accessed March 17, 2010.
- FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures. www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm. Published March 10, 2010. Accessed March 17, 2010.
- Lowes R. FDA announces new boxed warning for WinRho SDF. www.medscape.com/viewarticle/718311. Published March 10, 2010. Accessed March 17, 2010.
- WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of intravascular hemolysis. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm203739.htm. Published March 10, 2010. Accessed March 17, 2010.
- Dennis M. NICE releases draft guidance on use of anti-TNF therapies in rheumatoid arthritis. www.firstwordplus.com/Fws.do?articleid=7EE99FCAA87740958A6D883B4DCA5B35&logRowId=353557. Published March 3, 2010. Accessed March 17, 2010.