epoetin alfa, Epogen, Procrit (cont.)

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PREGNANCY: 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.

NURSING MOTHERS: 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.

SIDE EFFECTS: 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.

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