Epogen

DRUG DESCRIPTION

Epogen (epoetin alfa) is a 165-amino acid erythropoiesis-stimulating glycoprotein
manufactured by recombinant DNA technology. It has a molecular weight of approximately
30,400 daltons and is produced by mammalian cells into which the human erythropoietin
gene has been introduced. The product contains the identical amino acid sequence
of isolated natural erythropoietin.

Epogen is formulated as a sterile, colorless liquid in vials in multiple formulations.
Single-dose vials, formulated with an isotonic sodium chloride/sodium citrate-buffered
solution, are supplied in multiple strengths. Each 1 mL vial contains 2000,
3000, 4000, or 10,000 Units of epoetin alfa, Albumin (Human) (2.5 mg), citric
acid (0.06 mg), sodium chloride (5.9 mg), and sodium citrate (5.8 mg) in Water
for Injection, USP (pH 6.9 ± 0.3). Single-dose 1 mL vials formulated
with an isotonic sodium chloride/sodium phosphate buffer contain 40,000 Units
of epoetin alfa albumin (human) (2.5 mg),citric acid (0.0068 mg), sodium chloride
(5.8 mg), sodium citrate (0.7 mg), sodium phosphate dibasic anhydrate (1.8 mg),
and sodium phosphate monobasic monohydrate (1.2 mg) in Water for Injection,
USP (pH 6.9 ± 0.3). Multidose, 2 mL vials contain 10,000 Units epoetin
alfa, albumin (human) (2.5 mg), benzyl alcohol (1%), sodium chloride (8.2 mg),
and sodium citrate (1.3 mg) per 1 mL Water for Injection, USP (pH 6.1 ±
0.3). Multidose 1 mL vials contain 20,000 Units epoetin alfa, albumin (human)
(2.5 mg), benzyl alcohol (1%), sodium chloride (8.2 mg), citric acid (0.11 mg),
and sodium citrate (1.3 mg), per 1 mL in Water for Injection, USP (pH 6.1 ±
0.3).

What are the possible side effects of epoetin alfa (Epogen, Procrit)?

Contact your doctor if you feel weak, lightheaded, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.

Epoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use epoetin alfa. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea,...

Read All Potential Side Effects and See Pictures of Epogen »

What are the precautions when taking epoetin alfa (Epogen)?

Before using epoetin alfa, tell your doctor or pharmacist if you are allergic to it; or to other drugs that cause more red blood cells to be made (e.g., darbepoetin alfa); or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled high blood pressure.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure (treated/controlled), blood disorders (e.g., sickle cell anemia, white blood cell or...

Read All Potential Precautions of Epogen »

Epogen Consumer (continued)

SIDE EFFECTS: Headache, body aches, diarrhea, and irritation at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Epoetin alfa may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. This effect may be caused by the number of red blood cells increasing too quickly, usually within the first 3 months of starting treatment. If you have high blood pressure, it should be adequately controlled before beginning treatment with this medication. Your blood pressure should be checked frequently. Ask your doctor if you should learn how to monitor your own blood pressure. If high blood pressure develops or worsens, follow your doctor's instructions about diet changes and starting or adjusting your high blood pressure medication. Lowering high blood pressure helps prevent strokes, heart attacks, and further kidney problems. Keep all laboratory appointments to have your blood count (hemoglobin) tested regularly to reduce the chance of this side effect.

Tell your doctor immediately if any of these unlikely but serious side effects occur: seizures, confusion, loss of consciousness.

This medication may rarely cause blood clots. Seek immediate medical attention if you notice any of the following rare but very serious side effects: pain/redness/swelling/weakness of the arms or legs, calf pain/swelling that is warm to the touch, new/worsening shortness of breath, coughing up blood, sudden vision changes, slurred speech, weakness on one side of the body, sudden severe headache, chest/jaw/left arm pain, fainting, blood clots in your hemodialysis vascular access site.

Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies that reduce the effectiveness of epoetin alfa, and a very serious anemia can result. Tell your doctor immediately if symptoms of anemia return (e.g., increased tiredness, low energy, pale skin color, shortness of breath).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using epoetin alfa, tell your doctor or pharmacist if you are allergic to it; or to other drugs that cause more red blood cells to be made (e.g., darbepoetin alfa); or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled high blood pressure.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure (treated/controlled), blood disorders (e.g., sickle cell anemia, white blood cell or platelet problems, bone marrow problems), bleeding/clotting problems, blood vessel problems, heart problems (e.g., angina, heart failure), seizure disorder, a certain metabolic disorder (porphyria), certain vitamin deficiencies (folic acid, vitamin B12).

Infrequently, patients with long-term kidney failure on dialysis may be at increased risk of seizures during the first 3 months of treatment with this medication, possibly caused by the number of red blood cells increasing too quickly. Therefore, these patients should use caution and avoid activities such as driving or using machinery during this period. Limit alcoholic beverages because alcohol may also increase the risk of seizures.

Some forms of this medication are made from human blood. Even though the blood is carefully tested and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, virus infections such as hepatitis). Consult your doctor or pharmacist for more information.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. In some women of child-bearing age, menstrual periods have resumed with epoetin alfa treatment. Therefore, it may be possible to become pregnant while using this medication. Discuss the need for birth control with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Epogen Patient Information Including Side Effects

Brand Names: Epogen, Procrit

Generic Name: epoetin alfa (Pronunciation: e POE e tin AL fa)

• What is epoetin alfa (Epogen)?


• What are the possible side effects of epoetin alfa (Epogen)?


• What is the most important information I should know about epoetin alfa (Epogen)?


• What should I discuss with my healthcare provider before using epoetin alfa (Epogen)?


• How should I use epoetin alfa (Epogen)?


• What happens if I miss a dose (Epogen)?


• What happens if I overdose (Epogen)?


• What should I avoid while using epoetin alfa (Epogen)?


• What other drugs will affect epoetin alfa (Epogen)?


• Where can I get more information?

What is epoetin alfa (Epogen)?

Epoetin alfa is a man-made form of a protein that helps your body produce red blood cells. The amount of this protein in your body may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Epoetin alfa is used to treat anemia (a lack of red blood cells in the body).

Epoetin alfa may also be used for other purposes not listed in this medication guide.

What are the possible side effects of epoetin alfa (Epogen)?

Contact your doctor if you feel weak, lightheaded, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.

Epoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use epoetin alfa. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;


• feeling short of breath, even with mild exertion;


• sudden numbness or weakness, especially on one side of the body;


• sudden headache, confusion, problems with vision, speech, or balance; or


• pain or swelling in one or both legs.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using epoetin alfa and call your doctor at once if you have any of these serious side effects:

• feeling short of breath, even with mild exertion;


• swelling of your ankles or feet;


• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness);


• feeling light-headed, fainting; or


• seizure (black-out or convulsions).

Less serious side effects may include:

• dizziness, mild headache;


• fever, sore throat, body aches, flu symptoms;


• nausea, vomiting, diarrhea, constipation; or


• pain or tenderness where you injected the medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about epoetin alfa (Epogen)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use epoetin alfa. Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain or heavy feeling, pain spreading to the arm or shoulder, shortness of breath, slurred speech, or problems with vision or balance.

Before using epoetin alfa, tell your doctor if you have epilepsy or a history of seizures. Epoetin alfa may cause seizures. Be careful if you drive or do anything that requires you to be awake and alert.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of all items used in giving the medicine.

Contact your doctor if you feel weak, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to epoetin alfa.

Some women using epoetin alfa have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

Epoetin alfa is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Related Drug Centers

• Procrit


• Epogen