What is the black box warning for erythropoietin?
What is the black box warning for erythropoietin?
March 12, 2007 — A black-box warning has been added to the safety labeling for erythropoiesis-stimulating agents (ESAs) to advise of the increased risk for death and other serious adverse events associated with their use in patients with cancer and renal failure, the US Food and Drug Administration (FDA) said Friday.
Which conditions are erythropoiesis-stimulating agents contraindicated?
Epoetin alfa is contraindicated in patients with pure red cell aplasia (PRCA) that begins after treatment with epoetin or other erythropoietin protein drugs.
Does Epogen have a black box warning?
8, 2007 — The FDA today approved revisions to a “black box” warning and other safety-related label changes for the anemia drugs Procrit, Aranesp, and Epogen. Those drugs are erythropoiesis-stimulating agents (ESAs). They boost production of red blood cells.
What is the black box warning for epoetin alfa?
ROCKVILLE, Md. — The FDA warned today that aggressive use of erythropoiesis-stimulating agents to raise hemoglobin to a target of 12 g/dL or higher was associated with “serious and life-threatening side-effects and or/death.”
Which disease processes are seen in the black box warning of epoetin alfa Epogen )?
Epogen alpha is available as Procrit in 2,000 units, 3,000 units, 4,000 units, 10,000 units and 40,000 units. ESAs have a black box warning that ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor progression or recurrence.
What are the sites of erythropoiesis?
The formation of red blood cells in blood-forming tissue. In the early development of a fetus, erythropoiesis takes place in the yolk sac, spleen, and liver. After birth, all erythropoiesis occurs in the bone marrow.
What happens during Erythrocytosis?
Erythrocytosis is a condition in which your body makes too many red blood cells (RBCs), or erythrocytes. RBCs carry oxygen to your organs and tissues. Having too many of these cells can make your blood thicker than normal and lead to blood clots and other complications.
What is the black box warning for Procrit?
How is Epoetin administered?
Epoetin alfa injection products come as a solution (liquid) to inject subcutaneously (just under the skin) or intravenously (into a vein). It is usually injected one to three times weekly.
