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Eprex

(epoetin alfa)

In this factsheet:
• How does Eprex work? What will it do for me?
• How should I use Eprex?
• What form(s) does Eprex come in?
• Who should NOT take Eprex?
• What side effects are possible with Eprex?
• Are there any other precautions or warnings for Eprex?
• What other drugs could interact with Eprex?

DIN (Drug Identification Number)

What side effects are possible with Eprex?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• general feeling of tiredness or weakness
• pain, stinging, redness, or swelling around the injection site

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• clotting of the vascular access site (for people on hemodialysis)
• dehydration
• diarrhea
• edema (swelling of the face, fingers, ankles, feet, or lower legs)
• headache
• increased or decreased blood pressure, dizziness, or feeling faint
• muscle aches and pain
• nausea
• signs of infection (cough, fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, sore throat, stiff neck, weight loss, or listlessness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• chest pain
• seizures
• signs of allergic reaction (symptoms may include skin rash or hives, trouble breathing, sweating, abnormal heart rate, or decreased blood pressure)
• signs of blood clots (pain or swelling in the legs, worsening shortness of breath, coughing up blood)
• signs of stroke (confusion, severe headache, sudden weakness, dizziness, trouble speaking, or vision problems)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Eprex?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Blood clots: It has been identified in clinical trials that cancer patients who are treated with epoetin alfa to raise their hemoglobin beyond normal levels are at a higher risk of developing blood clots, which in some cases can cause death. Your doctor will monitor your hemoglobin level closely with blood tests during treatment with this medication.

If you experience symptoms such as sharp pain and swelling in the leg, or difficulty breathing, contact your doctor immediately.

Cancer: Epoetin alfa is used to treat anemia caused by chemotherapy treatment of non-myeloid cancers. It is not used to treat anemia that is due to the cancer itself.

Cardiovascular disease: This medication often affects blood pressure and can contribute to symptoms of heart disease. If you have high blood pressure, heart disease such as heart failure, angina, or a previous heart attack, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you are taking blood pressure pills to control blood pressure, it is important to continue taking them regularly while you are on epoetin alfa. Your doctor will monitor your hemoglobin (the protein in red blood cells that carry oxygen) until an appropriate dose of epoetin alfa has been determined.

Gout: This medication may cause symptoms of gout. If you have gout or a history of gout, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney disease: This medication may be used by people with chronic kidney disease who are receiving dialysis and who are not receiving dialysis. The dose may be different for each. Your doctor will monitor you closely for your response to the medication.

Medical conditions: Be sure to tell the doctor if you have any of the following medical problems, as they may affect how well this medication works:

• folic acid, iron, or vitamin B12 deficiency
• infection
• inflammation
• cancer
• bone problems
• blood diseases (e.g., sickle cell anemia)

Porphyria: If you have a history of porphyrin metabolism disorder (a metabolic disorder), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pure red cell aplasia: Cases of pure red cell aplasia (PRCA) have been reported among people treated with epoetin alfa. PRCA is a condition in which a person's bone marrow stops producing red blood cells, leading to severe anemia. People who develop PRCA may experience a new or worsening feeling of tiredness or shortness of breath. If you are experiencing such symptoms, call your doctor as soon as possible. Do not stop your medication without contacting your doctor first.

Seizure: This medication may contribute to an increase in seizures although the relationship between epoetin alfa and seizures is not clear. If you experience seizures or have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stroke: Epoetin alfa can increase the risk of blood clots forming in the blood vessels. If you have a past history of stroke, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience signs and symptoms of a stroke, such as blurred vision, difficulty speaking, sudden headache, or loss of coordination, contact your doctor immediately.

Worsening of anemia: Severe and sudden tiredness and shortness of breath could be a sign of severe anemia. People who develop these symptoms should see their doctor as soon as possible.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if epoetin alfa passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children less than 1 month of age. Epoetin alfa has been shown to be safe for children over the age of 1 month who need dialysis to treat chronic renal failure.

What other drugs could interact with Eprex?

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

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