Epoetin Question

medlineplus drug information: epoetin alfa injection

info added as black box warning label for medication nov 2007:

epoetin alfa increases the risk of serious and life-threatening events, including heart attack, heart failure, stroke, tia (ministroke) or cerebrovascular accident (blood clot to the brain), pulmonary embolus (blood clot to the lung), deep vein thrombosis (blood clot to the blood vessels), and death when treatment results in a higher than recommended amount of hemoglobin (red blood cells) in the blood..

epoetin alfa may increase the chance of death when used in people with cancer who are not receiving chemotherapy or radiation therapy at the same time they are using epoetin alfa. in people with cancer, epoetin alpha may cause a tumor to grow faster when the amount of hemoglobin (red blood cells) in the blood is higher than recommended....

use of medications similar to epoetin alpha in people just before major surgery increases the risk of blood clots.

nejm -- correction of anemia with epoetin alfa in chronic kidney ...background anemia, a common complication of chronic kidney disease, usually develops as a consequence of erythropoietin deficiency.

methods in this open-label trial, we studied 1432 patients with chronic kidney disease, 715 of whom were randomly assigned to receive a dose of epoetin alfa targeted to achieve a hemoglobin level of 13.5 g per deciliter and 717 of whom were assigned to receive a dose targeted to achieve a level of 11.3 g per deciliter. the median study duration was 16 months. the primary end point was a composite of death, myocardial infarction, hospitalization for congestive heart failure (without renal replacement therapy), and stroke.

results a total of 222 composite events occurred: 125 events in the high-hemoglobin group, as compared with 97 events in the low-hemoglobin group (hazard ratio, 1.34; 95% confidence interval, 1.03 to 1.74; p=0.03). there were 65 deaths (29.3%), 101 hospitalizations for congestive heart failure (45.5%), 25 myocardial infarctions (11.3%), and 23 strokes (10.4%). seven patients (3.2%) were hospitalized for congestive heart failure and myocardial infarction combined, and one patient (0.5%) died after having a stroke. improvements in the quality of life were similar in the two groups. more patients in the high-hemoglobin group had at least one serious adverse event.

manufacturers now have have letter out under fda safety advice due to above black box warning label notice:

indications and usage section - addition of a statement that in patients with

cancer, epogen®/procrit®/aranesp® has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being.

download letter to healthcare professionals (pdf, 52 kb)

[color=#007ec0]amgen announces update to u.s. prescribing information for aranesp® (darbepoetin alfa) and epogen® (epoetin alfa)

because of the length of time required for erythropoiesis — several days for erythroid progenitors to mature and be released into the circulation — a clinically significant increase in hematocrit is usually not observed in less than 2 weeks and may require up to 6 weeks in some patients.

chronic renal failure patients

hypertension: patients with uncontrolled hypertension should not be treated with epogen®; blood pressure should be controlled adequately before initiation of therapy. although there do not appear to

be any direct pressor effects of epogen®, blood pressure may rise during epogen® therapy. during the early phase of treatment when the hematocrit is increasing, approximately 25% of patients on

dialysis may require initiation of, or increases in, antihypertensive therapy.

hypertensive encephalopathy and seizures have been observed in patients with crf treated with epogen®. special care should be taken to closely monitor and aggressively control blood pressure in patients

treated with epogen®. patients should be advised as to the importance of compliance with antihypertensive therapy and dietary restrictions. if blood pressure is difficult to control by initiation of appropriate measures, the hemoglobin may be reduced by decreasing or withholding the dose of

epogen®. a clinically significant decrease in hemoglobin may not be observed for several weeks.

it is recommended that the dose of epogen® be decreased if the hemoglobin increase exceeds 1 g/dl in any 2-week period, because of the possible association of excessive rate of rise of hemoglobin with an exacerbation of hypertension.

in crf patients on hemodialysis with clinically evident ischemic heart

disease or congestive heart failure, the dose of epogen® should be carefully adjusted to achieve and maintain hemoglobin levels between 10-12 g/dl ...

seizures: seizures have occurred in patients with crf participating in epogen® clinical trials. in adult patients on dialysis, there was a higher incidence of seizures during the first 90 days of therapy

(occurring in approximately 2.5% of patients) as compared with later timepoints. given the potential for an increased risk of seizures during the first 90 days of therapy, blood pressure and the presence of premonitory neurologic symptoms should be monitored closely. patients should

be cautioned to avoid potentially hazardous activities such as driving or operating heavy machinery during this period....

click here to download the pdf version of prescribing information.