epoetin alfa

Epoetin alfa is a man-made, injectable drug for treating anemia associated with chronic kidney failure for people who are or will be receiving dialysis. Epoetin alfa is also used to treat anemia in individuals with HIV infection and in patients with cancer who are receiving chemotherapy.

Erythropoietin is a protein that normally is made in the body by the kidney. It 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. The erythropoietin that is used for therapy, called epoetin alfa, is man-made. It is a product of the genetic engineering of ovarian cells of the Chinese hamster and is produced through recombinant DNA technology in bacteria. It does not cure the underlying cause of the anemia, and unless the underlying cause can be reversed, treatment with epoetin alfa must be continued indefinitely.

Epoetin alfa belongs to a class of drugs called colony-stimulating factors because of their ability to stimulate cells in the bone marrow to multiply and form colonies of identical cells. Other colony-stimulating factors include filigrastim (Neupogen) and sargramostim (Leukine). Epogen and Procrit are both epoetin alfa, but they are marketed by two different pharmaceutical companies. The FDA approved epoetin alfa in June 1989.

What brand names are available for epoetin alfa?

Epogen, Procrit

Is epoetin alfa available as a generic drug?

GENERIC AVAILABLE: No

Do I need a prescription for epoetin alfa?

Yes

The most common side effects of epoetin alfa in patients with kidney failure on dialysis are:

• high blood pressure,
• headache,
• joint-pain and clotting at the injection site.

Rare cases of stinging at the injection site, skin rash and flu-like symptoms (joint and muscle pain) have occurred within a few hours following administration.

Allergic reactions, seizures, and thrombotic events (for example, heart attacks, strokes, and pulmonary embolism ) rarely occur.

In HIV-infected patients receiving zidovudine, the most common side effects with epoetin alfa are fever, headache, rash, and nasal or chest congestion. Rare cases of seizures or severe rash have occurred in these patients.

The most common side effects in patients undergoing surgery with anemia are:

• fever,
• nausea,
• constipation,
• skin reactions,
• vomiting and
• headaches.

Blood clots in veins, referred to as a deep venous thrombosis, also may occur.

Among patients with cancer receiving chemotherapy, the most common side effects of epoetin alfa are:

• fever,
• diarrhea,
• tissue swelling,
• shortness of breath,
• paresthesia (abnormal sensations like burning or prickling that may occur anywhere in the body), and
• upper respiratory infection.

Treatment with epoetin alfa may increase the growth of several types of cancer and reduce survival, and, therefore, its use should be restricted to the conditions discussed previously.

Epoetin alfa is administered intravenously or subcutaneously (under the skin) at 50-100 units/kg of body weight, three times weekly. The dose is tailored to each patient based on targeted hemoglobin levels. Adult patients with cancer receiving chemotherapy may be treated with 40,000 units weekly or 150 units/kg 3 times weekly.

Zidovudine treated patients should receive 100 units/kg 3 times weekly.

Surgery patients should receive 300 units/kg per day daily for 14 days or 600 units/kg weekly. The smallest effective dose should be used.

In clinical trials, the risk of death or serious heart problems, and stroke occurred more often when epoetin alpha was administered to target a hemoglobin level greater than 11 g/dL. Epoetin alfa vials should not be shaken since the drug may be damaged, and bubbles may form that prevent some of the drug from being drawn up into the syringe during injection. Iron stores should be evaluated before therapy and supplemental iron should be administered if needed.

No clinical studies have been done to demonstrate epoetin alfa drug interactions.

There are no studies of epoetin alfa use in pregnant women. Polyhydramnios and intrauterine growth restriction was reported in a small number of pregnant women who received epoetin alpha. Multiple dose vials contain benzyl alcohol and should not be administered to pregnant women.

It is not known if epoetin alfa is excreted into breast milk. Multiple dose vials contain benzyl alcohol and should not be administered to nursing mothers.

What preparations of epoetin alfa are available?

Vials containing liquid for injection: 2000, 3000, 4000, 10000, 20000 and 40000 U/ml as well as 20000 U/2ml

How should I keep epoetin alfa stored?

Epoetin alfa should be stored at 2 C - 8 C (36 F - 46 F). It should not be frozen. Multiple-use vials should be used within 21 days of the first use.