Epogen (epoetin alfa)

Epogen (epoetin alfa) is an intravenous medication used to treat anemia in patients on dialysis, patients receiving treatment for HIV, and patients receiving chemotherapy. Manufactured by Amgen Pharmaceuticals, Epogen is used to elevate and maintain a healthy red blood cell level and to decrease the need for transfusions in patients.

Why Prescribed

Epogen is prescribed for the treatment of anemia in patients who are receiving renal dialysis for kidney failure, patients with HIV infection who are receiving zidovudine, patients who are undergoing surgery, and patients who are receiving chemotherapy for cancer.

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FDA Approved Uses

Epogen (epoetin alfa) has been approved by the FDA to treat anemia and may be used to replace transfusions of red blood cells in patients who are undergoing surgery.

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Side Effects

The most common side effects associated with Epogen in patients on dialysis for kidney failure are high blood pressure, headache, joint-pain and clotting at the injection site.

In HIV-infected patients receiving zidovudine, the most common side effects with Epogen are fever, headache, rash, and nasal or chest congestion.

The most common side effects in anemic patients undergoing surgery with Epogen are fever, nausea, constipation, skin reactions, vomiting and headaches. Blood clots in veins, referred to as a deep venous thrombosis, have also been reported.

Among patients receiving chemotherapy, the most common side effects with Epogen are fever, diarrhea, tissue swelling, shortness of breath, paresthesia (abnormal sensations like burning or prickling that occurs anywhere in the body), and upper respiratory infection.

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Warnings and Alerts

On December 1, 2005, Amgen, Ortho Biotech and the FDA notified healthcare professionals of revision to the ‘Warnings, Precautions, Adverse Reactions, and Dosage and Administration’sections for Epogen, based upon a study that found a high risk of death, heart attack, hospitalizations for heart failure and stroke in patients with chronic kidney disease who were treated with Epogen.  The study found that Epogen raised patient hemoglobin levels higher than what the labeling for the product recommends and about half of all kidney dialysis patients had their red blood cell counts boosted beyond what the FDA says is safe--about 20% experienced red blood cell counts in the potential danger zone for stroke and heart attack.

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Drug Contraindications

Epogen is contraindicated in patients with uncontrolled hypertension, as epoetin alfa therapies may increase the risk of seizures, thrombotic events, and other serious events.

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FAQ's

What are the most important things I should know before taking Epogen?

You should not take Epogen if you have uncontrolled high blood pressure (high blood pressure is common in patients on dialysis), or if you have allergies to albumin or products made from animals. Epogen may also increase the risk of blood clots in your veins and lungs. This could cause pain and/or swelling in the legs and shortness of breath.  You should tell your doctor if you have any history of seizures, as seizures have occurred in patients on Epogen and are more likely during the first 90 days of therapy.

What is Erythropoietin?

Erythropoietin is a protein that is normally made in the body by the kidneys. The erythropoietin that is used for anemia therapy, called epoetin alfa, is man-made and causes the bone marrow to produce oxygen-carrying red blood cells. Under normal conditions, when the body senses a decrease in red blood cells or a deficiency in the supply of oxygen, more erythropoietin is produced, and this increases the number of red blood cells. When this natural mechanism is not working, it may become necessary to stimulate the bone marrow to produce red blood cells.  Epoetin alfa does not cure the underlying cause of the anemia, however, and unless the underlying cause can be reversed, treatment with epoetin alfa must be continued indefinitely.

Are there any warning signs that I should pay attention to while taking Epogen?

In their advisory, the FDA said that any patients taking Epogen should contact their doctor if they experience:

• Shortness of breath
• Pain in the legs
• Swelling in the legs
• Increase in blood pressure

If you or a loved one has experienced any health problems while taking Epogen, or if you have lost a loved one due to wrongful death from using Epogen, you should contact an experienced drug litigation attorney immediately to discuss your legal options, as all legal claims are subject to time limitations.

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