EFFICACY AND SAFETY
In anemic cancer patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy...
When treating anemia in CKD patients not on dialysis...
In patients undergoing elective, noncardiac, nonvascular surgery...
In anemic zidovudine-treated HIV-infected patientsō
FLEXIBLE DOSING
Convenient dosing options for individualized Hb control
  • Multiple dosing regimens
  • Range of single-dose and multidose vials
  • Dosing tailored to an individualӳ needs
  • Facilitates close Hb monitoring
  • Entire vials can be used
  • Minimizes waste


PROCRIT® INDICATIONS
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.
Anemia Due to Zidovudine in HIV-infected Patients
PROCRIT® is indicated for the treatment of anemia due to zidovudine administered at ≤4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of ≤500 mUnits/mL.
Anemia Due to Chemotherapy in Patients With Cancer
PROCRIT® is indicated for the treatment of anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
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 preoperatively.
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.
PROCRIT® 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 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 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®
PROCRIT® from multidose vials contains benzyl alcohol and is contraindicated in:
  • 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 Products, LP, at 1-800-JANSSEN (1-800-526-7736) 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.
Anemia in Patients with Chronic Kidney Disease Not on Dialysis
  • Consider initiating PROCRIT® treatment only when the hemoglobin level is less than 10 g/dL and:
    • The patientӳ rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and
    • Reducing the risk of alloimmunization and/or other RBC transfusion related risks is a goal.
  • If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of PROCRIT®, and use the lowest dose of PROCRIT® sufficient to reduce the need for RBC transfusions.
  • When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
    • Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
    • If the hemoglobin rises rapidly (e.g. more than 1 g/dL in any 2-week period), reduce the dose of PROCRIT® by 25% or more as needed to reduce rapid responses.
    • For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
    • For patients who do not respond adequately over a 12-week escalation period, increasing the PROCRIT® dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue PROCRIT® if responsiveness does not improve.
  • Adverse reactions in =5% of PROCRIT®-treated patients in clinical studies were hypertension and arthralgia.
Chemotherapy-Induced Anemia
  • PROCRIT® is not indicated for use in patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
  • PROCRIT® is not indicated for use in patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • Initiate PROCRIT® in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.
  • Use the lowest dose of PROCRIT® necessary to avoid RBC transfusions.
  • Reduce dose by 25% if:
    • Hemoglobin increases greater than 1 g/dL in any 2-week period or
    • Hemoglobin reaches a level needed to avoid RBC transfusion.
  • Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion. Reinitiate at a dose 25% below the previous dose when hemoglobin approaches a level where RBC transfusions may be required.
  • Adverse reactions in =5% of PROCRIT®-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis.
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.
Anemia in Zidovudine-treated HIV-infected Patients
  • Withhold PROCRIT® if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
  • Discontinue PROCRIT® if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.
  • Adverse reactions in =5% of PROCRIT®-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation.
Please see accompanying full Prescribing Information, including Boxed WARNINGS.
OR
Please see company representative for full Prescribing Information, including Boxed WARNINGS, or visit www.PROCRIT®.com.


016790-140611

 
Indications and Important Safety Information
EXPAND    Expand ISI
PROCRIT® INDICATIONS
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.

PROCRIT® should not be used for treatment of anemia:
  • If you have cancer and you are receiving hormones, biologic products or radiation therapy unless also receiving chemotherapy at the same time.
  • If you have cancer and you will not be receiving chemotherapy that may cause anemia for at least 2 more months.
  • If you have a cancer that has a high chance of being cured.
  • In place of emergency treatment for anemia (red blood cell transfusions).
PROCRIT® has not been proven to improve quality of life, fatigue, or well-being.

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.
PROCRIT® IMPORTANT SAFETY INFORMATION
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 has received special training in order to prescribe PROCRIT® and will talk with you in detail 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. 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 multi-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.
  • 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 using PROCRIT® from multi-dose vials in 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
  • Fever
  • Cough
  • Rash
  • Nausea
  • Vomiting
  • Soreness of mouth
  • Itching
  • Headache
  • 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 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.
016793-140611
Indications
Expand ISI
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.
Anemia Due to Zidovudine in HIV-infected Patients
PROCRIT® is indicated for the treatment of anemia due to zidovudine administered at =4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of =500 mUnits/mL.
Anemia Due to Chemotherapy in Patients With Cancer
PROCRIT® is indicated for the treatment of anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
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 preoperatively.
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.
Important Safety Information
Expand ISI
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 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 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®
PROCRIT® from multidose vials contains benzyl alcohol and is contraindicated in:
  • 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 Products, LP, at 1-800-JANSSEN (1-800-526-7736) 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.
Anemia in Patients with Chronic Kidney Disease Not on Dialysis
  • Consider initiating PROCRIT® treatment only when the hemoglobin level is less than 10 g/dL and:
    • The patient?s rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and
    • Reducing the risk of alloimmunization and/or other RBC transfusion related risks is a goal.
  • If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of PROCRIT®, and use the lowest dose of PROCRIT® sufficient to reduce the need for RBC transfusions.
  • When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
    • Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
    • If the hemoglobin rises rapidly (e.g. more than 1 g/dL in any 2-week period), reduce the dose of PROCRIT® by 25% or more as needed to reduce rapid responses.
    • For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
    • For patients who do not respond adequately over a 12-week escalation period, increasing the PROCRIT® dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue PROCRIT® if responsiveness does not improve.
  • Adverse reactions in =5% of PROCRIT®-treated patients in clinical studies were hypertension and arthralgia.
Chemotherapy-Induced Anemia
  • PROCRIT® is not indicated for use in patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
  • PROCRIT® is not indicated for use in patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • Initiate PROCRIT® in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.
  • Use the lowest dose of PROCRIT® necessary to avoid RBC transfusions.
  • Reduce dose by 25% if:
    • Hemoglobin increases greater than 1 g/dL in any 2-week period or
    • Hemoglobin reaches a level needed to avoid RBC transfusion.
  • Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion. Reinitiate at a dose 25% below the previous dose when hemoglobin approaches a level where RBC transfusions may be required.
  • Adverse reactions in =5% of PROCRIT®-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis.
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.
Anemia in Zidovudine-treated HIV-infected Patients
  • Withhold PROCRIT® if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
  • Discontinue PROCRIT® if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.
  • Adverse reactions in =5% of PROCRIT®-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation.
Please see accompanying full Prescribing Information, including Boxed WARNINGS.
OR
Please see company representative for full Prescribing Information, including Boxed WARNINGS, or visit www.PROCRIT®.com.


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