PROCRIT® (Epoetin alfa)
Anemia Due to Chronic Kidney Disease
PROCRIT® is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.
PROCRIT® has not been shown to improve quality of life, fatigue, or patient well-being.
PROCRIT® is not indicated for use:
- In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
- In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
- In patients scheduled for surgery who are willing to donate autologous blood.
- In patients undergoing cardiac or vascular surgery.
- As a substitute for RBC transfusions in patients who require immediate correction of anemia.
Click to learn more at PROCRIT.com
Click to view the Important Safety Information
Click to view the Full Prescribing Information, including Boxed WARNING
Click to view the Medication Guide for Patients
Click to view the Patient Instructions for use
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about PROCRIT® (epoetin alfa)?
Using PROCRIT® can lead to death or other serious side effects.
For patients with Cancer:
Your healthcare provider has received special training through the ESA APPRISE Oncology Program in order to prescribe PROCRIT®. Before you can begin to receive PROCRIT®, you must sign the patient-healthcare provider acknowledgment form. When you sign this form, you are stating that your healthcare provider talked with you about the risks of taking PROCRIT®.
These risks include that your tumor may grow faster and you may die sooner if you choose to take PROCRIT®.
You should talk with your healthcare provider about:
- Why PROCRIT® treatment is being prescribed for you.
- What are the chances you will get red blood cell transfusions if you do not take PROCRIT®.
- What are the chances you will get red blood cell transfusions even if you take PROCRIT®.
- How taking PROCRIT® may affect the success of your cancer treatment.
After you have finished your chemotherapy course, PROCRIT® treatment should be stopped.
For all patients who take PROCRIT®, including patients with cancer or chronic kidney disease:
- If you decide to take PROCRIT®, your healthcare provider should prescribe the smallest dose of PROCRIT® that is needed to reduce your chance of getting red blood cell transfusions.
- You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with PROCRIT® to reach a normal or near-normal hemoglobin level.
- You may get blood clots 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 will need to take a blood thinner to lessen the chance of blood clots during or following surgery. 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 of blood clots:
- 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
Who should not take PROCRIT®?
Do not take PROCRIT® if you:
- Have cancer and have not been counseled by your healthcare provider regarding the risks of PROCRIT® or if you have not signed the patient-healthcare provider acknowledgment form before you start PROCRIT® treatment.
- 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 multi-dose vials to:
- Pregnant or breastfeeding women
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.
- 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 breast-feeding or planning to breast-feed. 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.
Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider when you get a new medicine.
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 rash over your whole body, 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.
- Dangers of giving PROCRIT® to newborns, infants, and pregnant or breastfeeding women. Do not use PROCRIT® from multi-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. 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
- Soreness of mouth
- Redness and pain in the skin where PROCRIT® shots were given
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 and discuss 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 (1-800-332-1088).
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