Epogen: an injectable anemia medication

Some side effects of Epogen 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

Get emergency medical help if you have any of these signs of an allergic reaction while taking epoetin alfa (the active ingredient contained in Epogen) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Contact your doctor if you feel weak, lightheaded, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.

Epoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use epoetin alfa. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

·         chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

·         feeling short of breath, even with mild exertion;

·         swelling, rapid weight gain;

·         sudden numbness or weakness, especially on one side of the body;

·         sudden severe headache, confusion, problems with vision, speech, or balance; or

·         pain, swelling, warmth, or redness in one or both legs.

Stop using epoetin alfa and call your doctor at once if you have any of these serious side effects:

·         feeling light-headed, fainting;

·         fever, chills, body aches, flu symptoms, sores in your mouth and throat;

·         pale skin, feeling short of breath, rapid heart rate, trouble concentrating;

·        easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

·         seizure (black-out or convulsions);

·         low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

·    dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects of epoetin alfa may include:

·         cold symptoms such as stuffy nose, sneezing, cough, sore throat;

·         joint pain, bone pain;

·         muscle pain, muscle spasm;

·         dizziness, depression, mild headache;

·         weight loss;

·         sleep problems (insomnia);

·         nausea, vomiting, trouble swallowing; or

·         pain or tenderness where you injected the medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Immunologic

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.

General

Epoetin alfa generally has been well tolerated. A flu-like syndrome has been reported in 5% of patients receiving intravenous injections of epoetin alfa (the active ingredient contained in Epogen) 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.

Cardiovascular

The development or exacerbation of hypertension in patients with chronic renal failure is of concern. Epoetin alfa (the active ingredient contained in Epogen) 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

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 (the active ingredient contained in Epogen) (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

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 an 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

Psychiatric side effects have rarely included hallucinations among the dialysis patients treated with epoetin alfa (the active ingredient contained in Epogen)

Oncologic

Oncologic side effects, particularly with myeloid tumors, may occur due to epoetin alfa (the active ingredient contained in Epogen) 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

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

Dermatologic side effects have rarely included mild and transient skin rashes and urticaria.

 Local

 Local side effects of epoetin alfa (the active ingredient contained in Epogen) have included pain at the injection site.

If you are currently taking prescription medication for your symptoms and are interested in building more health and perhaps getting off your medication by addressing the cause of your health concern, please call the office and let us discuss your options.  I will work with your medical doctor to restore your health and reduce or eliminate the need for medication.

Dr. Huntoon has a single mission:

To support as many people as possible in their quest for health and enable them to improve and maintain their health to the highest level possible, while educating them about the benefits of Chiropractic, Natural Healthcare and Holistic Living, so they in turn can teach others to support us having a healthy community.

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• Continue doing the same thing and nothing changes or it may get worse

OR

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