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|Phase 3 Study Demonstrates Aranesp® (Darbepoetin Alfa) Reduces Red Blood Cell Transfusions In Patients With Myelodysplastic Syndrome (MDS)|
Safety data was consistent with the known safety profile of Aranesp, and the adverse events were generally balanced between treatment arms. The adverse events reported in the Aranesp arm at least five percent more frequently than in the placebo group were fatigue, pyrexia, headache and myalgia.
MDS is among the most common type of bone marrow failure syndromes in adults.1 The disease occurs when immature blood cells do not mature in the bone marrow. Patients with MDS have fewer healthy white blood cells, red blood cells and platelets, and are at risk of infection, anemia or bleeding.2 Current treatments for MDS include blood transfusions, chemotherapy and stem cell transplants.
"We are pleased to see positive results from this study, as anemia treatment options for myelodysplastic syndrome are limited and can place a significant burden on patients," said
About the ARCADE Study
About Aranesp® (darbepoetin alfa) in the U.S.
Aranesp® is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Limitations of Use:
Important U.S. Safety Information for Aranesp®
Chronic Kidney Disease:
Aranesp® is contraindicated in patients with uncontrolled hypertension, pure red cell aplasia (PRCA) that begins after treatment with Aranesp® or other erythropoietin protein drugs, or serious allergic reactions to Aranesp®.
Use caution in patients with CKD and coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks. In controlled clinical trials of patients with cancer, Aranesp® and other ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke. In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures. Control hypertension prior to initiating and during treatment with Aranesp®.
Aranesp® increases the risk of seizures in patients with CKD. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency.
For lack or loss of hemoglobin response to Aranesp®, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp®. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp® is not approved). If severe anemia and low reticulocyte count develop during treatment with Aranesp®, withhold Aranesp® and evaluate patients for neutralizing antibodies to erythropoietin. Permanently discontinue Aranesp® in patients who develop PRCA following treatment with Aranesp® or other erythropoietin protein drugs. Do not switch patients to other ESAs.
Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp®. Immediately and permanently discontinue Aranesp® if a serious allergic reaction occurs.
Adverse reactions (≥ 10%) in Aranesp® clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. Adverse reactions (≥ 1%) in Aranesp® clinical studies in cancer patients receiving chemotherapy were abdominal pain, edema, and thrombovascular events.
To see the Aranesp® Prescribing Information, including Boxed Warnings, and Medication Guide visit www.aranesp.com.
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The scientific information discussed in this news release relating to new indications for
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/phase-3-study-demonstrates-aranesp-darbepoetin-alfa-reduces-red-blood-cell-transfusions-in-patients-with-myelodysplastic-syndrome-mds-300220161.html