PROCRIT® (Epoetin Alfa)

PROCRIT®

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Important Safety Information

PROCRIT® (epoetin alfa) is a prescription infusion medication designed to treat anemia. It works by promoting the body’s creation of red blood cells (RBC) to avoid or reduce the need for blood transfusions. Since anemia is often a sign of an underlying medical condition, PROCRIT® is often used in patients with chronic kidney disease or HIV, or who are undergoing chemotherapy treatments. It can also be used for patients who are scheduled for a surgical procedure where a significant loss of blood is expected.

However, PROCRIT® isn’t suitable for everyone. It shouldn’t be used for treating cancer patients who meet any of the following criteria:

  • Your doctor has not suggested treatment with PROCRIT®
  • You will not undergo chemotherapy
  • Your cancer has a high probability of being cured
  • Your anemia is caused by chemotherapy but can be managed with RBC transfusions

PROCRIT® should not be used for patients who will undergo a surgical procedure. This includes if the patient is undergoing heart or blood vessel surgery or the patient is able and willing to donate blood prior to surgery.

It is unknown if PROCRIT® is safe to treat anemia in children younger than one-month-old who have chronic kidney disease, and in children younger than five years of age who have anemia caused by chemotherapy. You should talk to your child’s pediatrician about PROCRIT® before scheduling an appointment. PROCRIT® should also be avoided if you:

  • Have had a serious allergic reaction to one of the PROCRIT® ingredients
  • Have uncontrolled high blood pressure
  • Have Pure Red Cell Aplasia (PRCA) anemia

What is the most important information I should know about PROCRIT®?

If your hemoglobin increases too much or if it goes up too quickly, you may experience life-threatening health complications. PROCRIT® may also result in serious heart problems — including heart attack or failure — as well as stroke in patients with cancer or chronic kidney disease.

PROCRIT® may also increase the risk of blood clots. Talk to your doctor about the likelihood of needing to take blood thinners to reduce such complications — especially if you’re scheduled to undergo surgery.

Prior to starting treatment, talk to your doctor about your medical history, especially if you’ve suffered from high blood pressure, heart disease, seizures, stroke, or undergo dialysis. PROCRIT® may increase your risk if you’ve experienced these conditions in the past.

Multiple-dose vials should not be given to patients who are babies, or women who are pregnant or breastfeeding. Such vials may contain benzyl alcohol — which may cause brain damage and/or death.

It is unknown whether PROCRIT® could harm an unborn child. Therefore, tell your medical provider if you’re pregnant, there’s a possibility you may be pregnant, or were planning on doing so. It is also unknown whether PROCRIT® can pass to a baby through breast milk. If you have a newborn at home, talk with your doctor about feeding options.

Side Effects of PROCRIT®

As with any prescription medication, PROCRIT® carries the risk of side effects. The most common ones include:

  • Headaches
  • Soreness of the mouth
  • Weight loss
  • Muscle spasms
  • Fever
  • Cough
  • Chills
  • Redness and pain at the IV site
  • Joint, muscle, or bone pain
  • Nausea
  • Vomiting
  • Sleeping difficulties
  • Depression

PROCRIT® may also cause high blood pressure — even if you have no history of the condition. Therefore, it is crucial for a medical provider to monitor your blood pressure as you undergo treatment.

PROCRIT® may cause other serious side effects. Seek emergency medical care immediately if you experience any of the following symptoms:

  • Chest pain
  • Breathing difficulties
  • Speech difficulties
  • Vision loss
  • Loss of balance or coordination
  • Confusion
  • Dizziness
  • Leg pain
  • Cool or pale limbs
  • Numbness or weakness in your face or limbs — especially if it’s only on one side of your body
  • Seizures
  • Loss of consciousness
  • Hemodialysis vascular access stops working

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

PROCRIT® is used to treat anemia in patients with chronic kidney disease, HIV, or undergoing chemotherapy. The dosage and frequency of treatment will vary depending on the patient’s age and medical history.

Please refer to the full prescribing information.