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Epoetin Safety Reports

Drug Information: Epoetin Alfa Injection

IMPORTANT WARNING:

Why is this medication prescribed?

Epoetin alfa is used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time). Epoetin alfa is also used to treat anemia caused by chemotherapy (medications to treat cancer) or zidovudine (AZT, Retrovir, in Trizivir, in Combivir), a medication used to treat human immunodeficiency virus (HIV). Epoetin alfa is also used before and after certain types of surgery to decrease the number of blood transfusions (transfer of one person's blood to another person's body) needed for expected or actual blood loss during surgery. Epoetin alfa is in a class of medications called erythropoiesis-stimulating agents (ESAs). It works by causing the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.

How should this medicine be used?

Epoetin alfa comes as a solution (liquid) to inject subcutaneously (just under the skin) or intravenously (into a vein). It is usually injected one to three times weekly. When epoetin alfa is used to prevent and treat anemia due to surgery, it is sometimes injected once daily for 10 days before surgery, on the day of surgery and for 4 days after surgery. Alternatively, epoetin alfa is sometimes injected once weekly, beginning 3 weeks before surgery, with a dose also on the day of surgery. To help you remember to use epoetin alfa, mark a calendar to keep track of when you are to receive a dose. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use epoetin alfa exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor may start you on the lowest possible dose of epoetin alfa and gradually increase or decrease your dose, usually not more than once every month. Your doctor may also tell you to stop using epoetin alfa for a time. Follow these instructions carefully. If your doctor tells you to stop using epoetin alfa, do not begin using it again until your doctor tells you that you should. It is likely that your doctor will restart your treatment with a lower dose of epoetin alfa than you were using.

Epoetin alfa is used to reduce the need for red blood cell transfusions. It does not cure anemia. It may take up to 2 to 6 weeks of treatment before there is an increase in the number of red blood cells. Do not stop using epoetin alfa without talking to your doctor. If you do not respond to treatment with epoetin alfa, your doctor may check to see if there is another cause for your anemia.

Epoetin alfa injections are usually given by a doctor or nurse. Your doctor may decide that you can inject epoetin alfa yourself or that you may have a friend or relative give the injections. Your doctor will make sure the person who will be injecting the medication can give the injection correctly. Always follow the instructions of your doctor concerning the dose, how to give the medication, and how often to give the medication. Be sure that you and the person who will be giving the injections read the manufacturer's information for the patient that comes with epoetin alfa before you use it for the first time at home.

If you are using epoetin alfa at home, you will need to use disposable syringes and needles to inject your medication. Your doctor or pharmacist will tell you what type of syringe you should use. Do not use any other type of syringe because you may not get the right amount of medication. Always keep a spare syringe and needle on hand.

Use a disposable syringe or needle only one time. Throw away used syringes in a puncture-resistant container, out of the reach of children. Talk to your doctor or pharmacist about how to throw away the puncture-resistant container. Do not throw the container in your household trash. There may be special state and local laws for throwing away used needles and syringes.

If your doctor has prescribed epoetin alfa in a single use vial, the vial can be used only one time. Do not put a needle through the rubber stopper of the vial more than once. Throw away the vial after you have used it for one dose, even if it is not empty.

Always inject epoetin alfa in its own syringe; never mix it with any other medication.

If you are injecting epoetin alfa subcutaneously, you can inject it just under the skin anywhere on the outer area of your upper arms, middle of the front thighs, stomach (except for a 2-inch area around the navel), or outer area of the buttocks. Do not inject epoetin alfa into a spot that is tender, red, bruised, hard, or has scars or stretch marks. Choose a new spot each time you inject epoetin alfa, as directed by your doctor. Write down the date, time, dose of epoetin alfa, and the spot where you injected your dose in a record book.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses. Talk to your doctor about the risks of using this medication for your condition.

What special precautions should I follow?

Before using epoetin alfa,

• tell your doctor and pharmacist if you are allergic to epoetin alfa, darbepoetin alfa (Aranesp), medications made from animal cells, albumin, any other medications or benzyl alcohol. Ask your doctor or pharmacist if you don't know if a medication you are allergic to is made from animal cells.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have had high blood pressure. Your doctor may tell you not to use epoetin alfa.
• tell your doctor if you have or have ever had bleeding or blood clotting problems; cancer; diseases that affect your blood such as leukemia, myelodysplastic syndrome (condition in which the bone marrow can not produce enough blood cells), sickle cell disease (an inherited blood disease that causes pain, anemia, and organ damage), thalassemia (an inherited blood disease that causes abnormal development and other problems), or porphyria (an inherited blood disease that may cause skin or nervous system problems); blood clots in your heart, legs, or lungs; a heart attack; an infection; stroke or mini-stroke (TIA); tumors; heart disease, or any disease that affects your brain or nervous system.
• tell your doctor if you have used epoetin alfa or another erythropoiesis-stimulating agent such as darbepoetin alfa (Aranesp) in the past. Be sure to tell your doctor if your anemia worsened during your treatment with one of these medications, or if you were ever told to stop using one of these medications.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using epoetin alfa, call your doctor. If you stopped menstruating (getting your period) because of your anemia, you may begin to menstruate again while you are using epoetin alfa. This may increase the chance that you will become pregnant. Talk to your doctor about the type of birth control that is right for you.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using epoetin alfa.
• you should know that epoetin alfa may cause seizures, usually during the first 3 months of treatment. Talk to your doctor about driving a car, operating machinery, or participating in dangerous activities during this time.
• you should know that your blood pressure may increase while you are using epoetin alfa. Your doctor may ask you to monitor your blood pressure frequently. Be sure to check your blood pressure as often as your doctor tells you that you should, to call your doctor if your blood pressure is higher than your doctor says it should be, and to take any medications your doctor prescribes to control your blood pressure exactly as directed.
• you should call your doctor if you are planning to travel or if your activity becomes limited, such as spending more time sitting or in bed.

What special dietary instructions should I follow?

If you are following a prescribed special diet because you have kidney disease or high blood pressure, follow it carefully, even if you feel better while using epoetin alfa. Epoetin alfa will not work unless your body has enough iron. Your doctor or dietician will probably tell you to eat foods that are rich in iron. If you cannot get enough iron from your diet, your doctor may prescribe an iron supplement. Take this supplement exactly as directed.

What should I do if I forget a dose?

Call your doctor to ask what to do if you miss a dose of epoetin alfa. Do not use a double dose to make up for a missed one.

What side effects can this medication cause?

Epoetin alfa may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• joint or muscle aches, pain, or soreness
• nausea
• vomiting
• indigestion
• stomach pain
• diarrhea
• constipation
• difficulty falling asleep or staying asleep
• rash
• itching
• pain, burning, numbness, or tingling in the hands or feet

Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately.

• fever, sore throat, chills, cough, and other signs of infection
• redness, swelling, pain, or itching at the injection spot
• spreading rash over the whole body
• hives
• swelling of the face, throat, tongue, lips, eyes
• wheezing
• difficulty breathing or swallowing
• hoarseness
• lack of energy
• feeling cold most of the time

Epoetin alfa may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator, but do not freeze it. Keep epoetin alfa away from excess heat and moisture (not in the bathroom) and sunlight. Throw away any medication that is outdated or no longer needed. Throw away a multidose vial of epoetin alfa 21 days after you first use it. Talk to your pharmacist about the proper disposal of your medication.

When traveling, place epoetin alfa in its original box in an insulated cooler with coolant such as blue ice. Do not place epoetin alfa vials directly on ice or coolants, and do not allow them to freeze. If a vial does freeze, do not use it. Once you arrive, place the medication in a refrigerator as soon as possible.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• pain, tenderness, redness, warmth, and/or swelling in the legs
• chest pain, squeezing pressure, or tightness
• discomfort or pain in the arms, shoulder, neck, jaw, or back
• fast or irregular heartbeat
• shortness of breath
• cough that won't go away or coughing up blood
• swelling of the hands, feet, or ankles
• blue-grey color or darkening around mouth or nails
• excessive sweating
• dizziness or lightheadedness
• fainting or loss of consciousness
• sudden trouble seeing in one or both eyes
• sudden confusion
• sudden trouble speaking or understanding speech
• sudden weakness or numbness of an arm or leg, (especially on one side of the body) or face
• sudden trouble walking or loss of balance or coordination
• sudden severe headache
• extreme tiredness or weakness
• seizure
• increased blood pressure
• blood clot in hemodialysis port

What other information should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using epoetin alfa.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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