Surgery Products
PROCRIT® (Epoetin alfa)
Important safety update, including boxed warning. Please read more
Product alert: Voluntary product recall notice. Please read more.
Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery
PROCRIT® is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin >10 to ≤13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. PROCRIT® is not indicated for patients who are willing to donate autologous blood pre-operatively.
- PROCRIT® use has not been shown to improve quality of life, fatigue, or patient well-being.
- PROCRIT® is not indicated for use in patients scheduled for surgery who are willing to donate autologous blood.
- PROCRIT® is not indicated for use in patients undergoing cardiac or vascular surgery.
- PROCRIT® is not indicated 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 WARNINGS
Click to view the Medication Guide for Patients
Click to view the Patient Instructions for use
IMPORTANT SAFETY INFORMATION
WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
- In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
- No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
- Use the lowest PROCRIT® dose sufficient to reduce the need for red blood cell (RBC) transfusions.
Cancer:
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
- Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology program to prescribe and/or dispense PROCRIT® to patients with cancer. To enroll in the ESA APPRISE Oncology program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
- To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid red blood cell (RBC) transfusions.
- Use ESAs only for anemia from myelosuppressive chemotherapy.
- ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
- Discontinue following the completion of a chemotherapy course.
Perisurgery:
Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended.
(See WARNINGS AND PRECAUTIONS: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism, WARNINGS AND PRECAUTIONS: Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)
Contraindications
PROCRIT® is contraindicated in patients with:
- Uncontrolled hypertension
- Pure red cell aplasia (PRCA) that begins after treatment with PROCRIT® or other erythropoietin protein drugs
- Serious allergic reactions to PROCRIT®
- Neonates, infants, pregnant women, and nursing mothers. When therapy with PROCRIT® is needed in neonates and infants, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol.
Additional Important Safety Information
Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism
- In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 -14 g/dL) to lower targets (9 - 11.3 g/dL), PROCRIT® and other ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups.
- Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.
- In controlled clinical trials of patients with cancer, PROCRIT® and other ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke.
- In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.
Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer
- ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. These findings were observed in studies of patients with advanced head and neck cancer receiving radiation therapy, in patients receiving chemotherapy for metastatic breast cancer or lymphoid malignancy, and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy.
Hypertension
- PROCRIT® is contraindicated in patients with uncontrolled hypertension. Following initiation and titration of PROCRIT®, approximately 25% of patients on dialysis required initiation of or increases in antihypertensive therapy; hypertensive encephalopathy and seizures have been reported in patients with CKD receiving PROCRIT®.
- Appropriately control hypertension prior to initiation of and during treatment with PROCRIT®. Reduce or withhold PROCRIT® if blood pressure becomes difficult to control. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions.
Seizures
- PROCRIT® increases the risk of seizures in patients with CKD. During the first several months following initiation of PROCRIT®, monitor patients closely for premonitory neurologic symptoms. Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms or change in seizure frequency.
Lack or Loss of Hemoglobin Response to PROCRIT®
- For lack or loss of hemoglobin response to PROCRIT®, initiate a search for causative factors (e.g., iron deficiency, infection, inflammation, bleeding). If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to PROCRIT® therapy.
Pure Red Cell Aplasia
- Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with PROCRIT®. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which PROCRIT® is not approved).
- If severe anemia and low reticulocyte count develop during treatment with PROCRIT®, withhold PROCRIT® and evaluate patients for neutralizing antibodies to erythropoietin. Contact Janssen Biotech, Inc. (1-800-457-6399), to perform assays for binding and neutralizing antibodies. Permanently discontinue PROCRIT® in patients who develop PRCA following treatment with PROCRIT® or other erythropoietin protein drugs. Do not switch patients to other ESAs.
Serious Allergic Reactions
- Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with PROCRIT®. Immediately and permanently discontinue PROCRIT® and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs.
Laboratory Monitoring
- Evaluate transferrin saturation and serum ferritin prior to and during PROCRIT® treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion.
PROCRIT® is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
Surgery/Perisurgery
- PROCRIT® is not indicated for use in patients scheduled for surgery who are willing to donate autologous blood.
- PROCRIT® is not indicated for use in patients undergoing cardiac or vascular surgery.
- Deep venous thrombosis prophylaxis is recommended during PROCRIT® therapy.
- Adverse reactions in ≥5% of PROCRIT®-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.
Talk to your doctor if you have any questions about this information.
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.
Please see Full Prescribing Information
Please read the Medication Guide for PROCRIT® and discuss with your doctor.
Instructions if you or your caregiver has been trained to give PROCRIT® injections at home.