Epoetin alfa Side Effects
Some side effects of epoetin alfa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to epoetin alfa: injection solution
Along with its needed effects, epoetin alfa may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking epoetin alfa:More common
- Chest pain
- increased blood pressure
- shortness of breath
- swelling of the face, fingers, ankles, feet, or lower legs
- weight gain
- blurred vision
- change in skin color
- change in vision
- convulsions (seizures)
- dizziness or lightheadedness
- double vision
- fast heartbeat
- migraine headache
- pain or discomfort in the arms, jaw, back, or neck
- pain, tenderness, or swelling of the foot or leg
- pains in the chest, groin, or legs, especially calves of the legs
- pale skin
- partial or complete loss of vision in the eye
- severe headaches of sudden onset
- skin rash or hives
- slurred speech
- sore throat
- sudden and severe inability to speak
- sudden loss of coordination
- sudden vision changes
- temporary blindness
- tenderness, pain, swelling, warmth, or skin discoloration at the injection site
- unusual bleeding or bruising
- unusual tiredness or weakness
- vision problems
- weakness in the arm or leg on one side of the body, sudden and severe
Some side effects of epoetin alfa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Abdominal or stomach pain and swelling
- bone or joint pain, muscle aches, chills, shivering, or sweating
- general feeling of tiredness or weakness
- heartburn or belching, acid or sour stomach
- inability to sleep
- itching or stinging at the injection site
- loss of strength or energy
- muscle pain or weakness
- skin pain
- stomach discomfort, upset, or pain
- weight loss
For Healthcare Professionals
Applies to epoetin alfa: injectable solution
Immunologic side effects including neutralizing antibodies to erythropoietin, in association with pure red cell aplasia (PRCA) or severe anemia (with or without cytopenias) have been reported.
Epoetin alfa generally has been well tolerated. A flu-like syndrome has been reported in 5% of patients receiving intravenous injections of epoetin alfa. This syndrome includes low-grade fever, arthralgias, myalgias, and flank pain. These symptoms may be managed by subcutaneous administration or a slower rate of intravenous administration. Many patients receiving epoetin alfa have serious underlying conditions and it is sometimes difficult to discern true drug toxicity from disease activity.
The most frequently reported adverse effects observed in patients on dialysis were hypertension, headache, tachycardia, nausea and vomiting, clotted vascular access, shortness of breath, hyperkalemia, and diarrhea. In zidovudine treated HIV patients, the incidence of epoetin alfa side effects were not statistically significant from those in the placebo group and were consistent with disease progression. Diarrhea and edema occurred at a statistically significant greater incidence (compared to placebo) in cancer patients on chemotherapy.
The development or exacerbation of hypertension in patients with chronic renal failure is of concern. Epoetin alfa associated hypertension does not appear to depend on preexisting hypertension and one study suggests a relationship between new onset hypertension and an hematocrit of less than 20%. The mechanism for development of hypertension has not been established, but may be due to increased blood viscosity as red cell production increases or increased peripheral resistance as the anemia is corrected. Therapeutic endpoints should be approached slowly and preexisting hypertension should be controlled prior to initiating therapy.
Cardiovascular side effects have been reported the most frequently. These have included hypertension, myocardial infarction, and tachycardia. Up to 35% of patients with hypertension due to chronic renal failure may require additional antihypertensive medication or an adjustment of an existing regimen.
Deep vein thrombosis has been reported in at least one patient receiving 20,000 units three times a week.
Increased mortality has been observed in cardiac patients (ischemic heart disease or congestive heart failure) on hemodialysis with a target hematocrit of 42% compared to similar patients with a target hematocrit of 30% (mortality rate 35% and 29%, respectively). The incidence of nonfatal myocardial infarctions, vascular access thrombosis, and all other thrombotic events was also increased in patients randomized to the higher target hematocrit. Maintenance of hematocrit levels between 30% and 36% is recommended.
A significant increase in thrombosis and mortality has been associated with the use of epoetin alfa (compared to placebo) in patients without renal failure undergoing coronary bypass surgery. In patients receiving epoetin who are at risk for thrombosis, the risk versus benefit of therapy should be individually evaluated.
Hematologic side effects have included incidences of vascular access thrombosis. All other thrombotic events were increased in cardiac patients randomized to a target hematocrit (HCT) of 42% compared to a target HCT of 30%. Maintenance of HCT levels between 30% and 36% is recommended.
A significant increase in thrombosis and mortality has been associated with the use of epoetin alfa (compared to placebo) in patients without renal failure undergoing coronary bypass surgery. In patients requiring epoetin who are at risk for thrombosis, the risk versus benefit of therapy should be individually evaluated.
Iron deficiency has occurred in most patients due to incorporation of iron into newly synthesized red blood cells. Supplemental iron may be necessary.
Arteriovenous shunt clotting may occur in hemodialysis patients due to increased blood viscosity and decreased bleeding time, however, the incidence does not appear to be greater than in hemodialysis patients not receiving epoetin alfa. Clotting within the dialyzer has resulted in a 25% increase in heparin anticoagulation requirements during hemodialysis.
Iron stores are readily incorporated into new red blood cells as hemoglobin is produced during the acute phase of drug therapy. Iron deficiency diminishes the therapeutic effect of the drug. Iron replacement is necessary in nearly all patients treated with epoetin alfa, and iron status should be evaluated prior to initiating therapy and at regular intervals. A transferrin saturation of less than 20% or a serum ferritin level of less than 100 mcg/L suggests inadequate iron stores and a need for iron replacement therapy.
Nervous system side effects have included headache (15%) and seizures (to 5%).
Seizures have occurred primarily in the first three months of therapy and may have been associated with a increase in hematocrit or blood pressure. Neurologic monitoring and evaluation during epoetin alfa therapy is recommended in patients with a history of seizure activity. Therapeutic endpoints should be approached slowly to minimize seizure risks.
Psychiatric side effects have rarely included hallucinations among the dialysis patients treated with epoetin alfa.
Oncologic side effects, particularly with myeloid tumors, may occur due to epoetin alfa's growth factor activity.
Erythropoietin receptors have been found to be present on the surface of some malignant cell lines and tumor biopsy specimens. However, there is insufficient data to establish whether use of epoetin products have an adverse effect on time to tumor progression or progression-free survival.
Gastrointestinal side effects have included nausea, vomiting, and diarrhea, but these have not occurred at an incidence significantly greater than reported in placebo groups amongst patients with chronic renal failure and HIV-infected patients treated with zidovudine. Diarrhea occurred at a statistically significant greater incidence (compared to placebo) in cancer patients on chemotherapy.
Dermatologic side effects have rarely included mild and transient skin rashes and urticaria.
Local side effects of epoetin alfa have included pain at the injection site.
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