Eprex

Epoetin alfa is available only as an injection, which is given subcutaneously (under the skin) or intravenously (into a vein). People who receive the medication under the skin can usually be taught to self-administer the medication. Be sure you understand exactly how it is to be injected, as instructed by your doctor or nurse. People who need to receive the medication into a vein will need to have the medication administered by a doctor or nurse.

For children with chronic renal failure, the starting dose for anemia is 50 units (IU) per kilogram body weight, given 3 times a week.

For adults with chronic renal failure, the starting dose for anemia is 50 to 100 units per kilogram of body weight, injected three times a week.

For anemia in adults with HIV, the usual starting dose is 100 units per kilogram body weight, injected 3 times a week.

For people with anemia due to chemotherapy, the starting dose is 150 units per kilogram of body weight, injected subcutaneously 3 times a week. As an alternative, epoetin alfa may be injected subcutaneously once weekly as a dose of 40,000 units.

When epoetin alfa is used in people scheduled for surgery, higher doses are used.

Your doctor may need to adjust the dose according to your body's response to the medication. Adjustments usually involve blood tests and are not done more often than once every 4 weeks. While you are being treated with epoetin alfa, your doctor may want you to take iron supplements to help the medication work as well as possible.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use Eprex (Erythropoietin-human) exactly as prescribed by your doctor. If you miss a dose, administer it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

If you miss an appointment to receive epoetin alfa, contact your doctor as soon as possible to reschedule your appointment.

Epoetin alfa should be refrigerated and protected from light. Do not let it freeze. The prefilled syringe should be allowed to warm to room temperature just before injecting it, and may be stored for up to 7 days at room temperature. Do not shake the medication before use.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause diarrhea; it may cause joint pain; it may increase your blood pressure; it may cause nausea or, rarely, vomiting; it may cause flu-like symptoms. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each syringe of sterile solution contains epoetin alfa 1,000 IU, 2,000 IU, 3,000 IU, 4,000 IU, 5,000 IU, 6,000 IU, 8,000 IU, 10,000 IU, 20,000 IU, 30,000 IU, or 40,000 IU. Nonmedicinal ingredients: glycine and polysorbate 80 as stabilizers, sodium chloride, sodium phosphate dibasic dihydrate, sodium phosphate monobasic dihydrate, and water for injection.

Do not take Eprex (Erythropoietin-human) if you:

• are allergic to epoetin alfa or any ingredients of the medication
• are allergic to medications made from mammalian cells
• are scheduled for surgery and have severe disease of the heart or blood vessels
• have developed a condition called pure red cell aplasia (PRCA) after using erythropoiesis-stimulating proteins (e.g., epoetin alfa, darbepoetin alfa)
• have uncontrolled high blood pressure
• cannot receive medication to treat blood clotting

There may be an interaction between epoetin alfa and any of the following:

• Lenalidomide
• Pomalidomide
• thalidomide

If you are taking any of these medications, speak with your doctor or pharmacist. 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.

Medications other than those listed above may interact with Eprex (Erythropoietin-human). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications 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.

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 Eprex (Erythropoietin-human).

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 Eprex (Erythropoietin-human).

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. If you have cancer and your hemoglobin is kept too high, your cancer may grow faster or you may have an increased risk of Heart Attack or stroke. Discuss any concerns you have with your doctor.

Cardiovascular disease: Eprex (Erythropoietin-human) 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 Eprex (Erythropoietin-human) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Eprex (Erythropoietin-human), 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: Eprex (Erythropoietin-human) may cause symptoms of gout. If you have gout or a history of gout, discuss with your doctor how Eprex (Erythropoietin-human) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Eprex (Erythropoietin-human), and whether any special monitoring is needed.

Kidney disease: Eprex (Erythropoietin-human) may be used by people with chronic kidney disease who are receiving dialysis and those 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 Eprex (Erythropoietin-human) works:

• folic acid, iron, or vitamin B12 deficiency
• excess aluminum in the blood
• 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 Eprex (Erythropoietin-human) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Eprex (Erythropoietin-human), 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: Eprex (Erythropoietin-human) 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 Eprex (Erythropoietin-human) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Eprex (Erythropoietin-human), 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 Eprex (Erythropoietin-human) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Eprex (Erythropoietin-human), 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: Eprex (Erythropoietin-human) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Eprex (Erythropoietin-human), 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 Eprex (Erythropoietin-human), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Eprex (Erythropoietin-human) 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.

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. Use this medication regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this.