Procrit®

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INDICATIONS

WHAT IS PROCRIT®?

PROCRIT® (epoetin alfa) is used to treat a lower than normal number of red blood cells (anemia) caused by:

  • Chronic kidney disease in patients on dialysis and not on dialysis.
  • Chemotherapy that will be used for at least 2 months after starting PROCRIT®.
  • A medicine called zidovudine (AZT) used to treat HIV infection.

PROCRIT® may also be used to reduce the chance you will need red blood cell transfusions if you are scheduled for certain surgeries where a lot of blood loss is expected.

If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take PROCRIT®, even if you do not have an increase in your hemoglobin level.

PROCRIT® has not been proven to improve quality of life, fatigue, or well-being.

PROCRIT® should not be used for treatment of anemia:

  • If you have cancer and you will not be receiving chemotherapy that may cause anemia.
  • If you have a cancer that has a high chance of being cured.
  • If your anemia caused by chemotherapy treatment can be managed by RBC transfusion.
  • In place of emergency treatment for anemia (red blood cell transfusions).

PROCRIT® should not be used to reduce the chance of red blood cell transfusions if:

  • You are scheduled for surgery on your heart or blood vessels.
  • You are able and willing to donate blood prior to surgery.

It is not known if PROCRIT® is safe and effective in treating anemia in children less than 1 month old who have chronic kidney disease and in children less than 5 years old who have anemia caused by chemotherapy.

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Important Safety Information For PROCRIT®

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

PROCRIT® may cause serious side effects that can lead to death, including:

For people with cancer:

Your tumor may grow faster and you may die sooner if you choose to take PROCRIT®. Your healthcare provider will talk with you about these risks.

For all people who take PROCRIT®, including patients with cancer or chronic kidney disease:

  • Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with PROCRIT® to increase red blood cells (RBCs) to near the same level found in healthy people.
  • Blood Clots. Blood clots may happen at any time while taking PROCRIT®. If you are receiving PROCRIT® for any reason and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Blood clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus).
  • Call your healthcare provider or get medical help right away if you have any of these symptoms:
    • Chest pain
    • Trouble breathing or shortness of breath
    • Pain in your legs, with or without swelling
    • A cool or pale arm or leg
    • Sudden confusion, trouble speaking, or trouble understanding others' speech
    • Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body
    • Sudden trouble seeing
    • Sudden trouble walking, dizziness, loss of balance or coordination
    • Loss of consciousness (fainting)
    • Hemodialysis vascular access stops working

If you decide to take PROCRIT®, your healthcare provider should prescribe the smallest dose of PROCRIT® that is necessary to reduce your chance of needing red blood cell transfusions.

Who should not take PROCRIT®?

Do not take PROCRIT® if you:

  • Have cancer and have not been counseled by your healthcare provider about treatment with PROCRIT®.
  • Have high blood pressure that is not controlled (uncontrolled hypertension).
  • Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with PROCRIT® or other erythropoietin protein medicines.
  • Have had a serious allergic reaction to PROCRIT®.

Do not give PROCRIT® from multiple-dose vials to:

  • Pregnant or breastfeeding women
  • Babies

What should I tell my healthcare provider before taking PROCRIT®?

PROCRIT® may not be right for you. Tell your healthcare provider about all your health conditions, including if you:

  • Have heart disease.
  • Have high blood pressure.
  • Have had a seizure (convulsion) or stroke.
  • Receive dialysis treatment.
  • Have any other medical conditions.
  • Are pregnant or planning to become pregnant. It is not known if PROCRIT® may harm your unborn baby. Talk with your healthcare provider about possible pregnancy and birth control choices that are right for you.
  • Are breastfeeding or planning to breastfeed. It is not known if PROCRIT® passes into breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

What are the possible side effects of PROCRIT®?

PROCRIT® may cause serious side effects.

  • See "What is the most important information I should know about PROCRIT®?"
  • High blood pressure. High blood pressure is a common side effect of PROCRIT® in patients with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking PROCRIT®. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often. If your blood pressure does go up, your healthcare provider may prescribe new or more blood pressure medicine.
  • Seizures. If you have any seizures while taking PROCRIT®, get medical help right away and tell your healthcare provider.
  • Antibodies to PROCRIT®. Your body may make antibodies to PROCRIT®. These antibodies can block or lessen your body's ability to make red blood cells and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking PROCRIT®.
  • Serious allergic reactions. Serious allergic reactions can cause a skin rash, itching, shortness of breath, wheezing, dizziness and fainting because of a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using PROCRIT® and call your healthcare provider or get medical help right away.
  • Severe skin reactions. Signs and symptoms of severe skin reactions with PROCRIT® may include: skin rash with itching, blisters, skin sores, peeling, or areas of skin coming off. If you have any signs or symptoms of a severe skin reaction, stop using PROCRIT® and call your healthcare provider or get medical help right away.
  • Dangers of using PROCRIT® from multiple-dose vials in newborns, infants, and pregnant or breastfeeding women. Do not use PROCRIT® from multiple-dose vials in newborns, infants, pregnant or breastfeeding women because the PROCRIT® in these vials contains benzyl alcohol. Benzyl alcohol has been shown to cause brain damage, other serious side effects, and death in newborn and premature babies. If you use PROCRIT® from multiple-dose vials, you should not breastfeed for at least 2 weeks after the last dose. PROCRIT® that comes in single-dose vials does not contain benzyl alcohol. See "Who should not take PROCRIT®?".

Common side effects of PROCRIT® include:

  • Joint, muscle, or bone pain
  • Fever
  • Cough
  • Dizziness
  • High blood sugar
  • Low potassium levels in the blood
  • Chills
  • Redness and pain at the PROCRIT® injection site
  • Rash
  • Nausea
  • Vomiting
  • Blood vessel blockage
  • Low white blood cells
  • Trouble sleeping
  • Difficulty swallowing
  • Soreness of mouth
  • Itching
  • Headache
  • Respiratory infection
  • Weight decrease
  • Depression
  • Muscle spasm

These are not all of the possible side effects of PROCRIT®. Your healthcare provider can give you a more complete list. Tell your healthcare provider about any side effects that bother you or that do not go away.

Please read the Medication Guide for PROCRIT® (epoetin alfa) and discuss it with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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