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Eprex (PROCRIT) 4000 IU 0.4 mL 6 Prefilled Syringe

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FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

1 INDICATIONS AND USAGE

1.1 Anemia Due to Chronic Kidney Disease

1.2 Anemia Due to Zidovudine in HIV-infected Patients

1.3 Anemia Due to Chemotherapy in Patients With Cancer

1.4 Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery

1.5 Limitations of Use

2 DOSAGE AND ADMINISTRATION

2.1 Evaluation of Iron Stores and Nutritional Factors

2.2 Patients with Chronic Kidney Disease

2.3 Zidovudine-treated HIV-infected Patients

2.4 Patients on Cancer Chemotherapy

2.5 Surgery Patients

2.6 Preparation and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism

5.2 Prescribing and Distribution Program for EPREX (PROCRIT) in Patients With Cancer

5.3 Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer

5.4 Hypertension

5.5 Seizures

5.6 Lack or Loss of Hemoglobin Response to EPREX (PROCRIT)

5.7 Pure Red Cell Aplasia

5.8 Serious Allergic Reactions

5.9 Albumin (Human)

5.10 Dialysis Management

5.11 Laboratory Monitoring

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

6.2 Postmarketing Experience

6.3 Immunogenicity

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.3 Reproductive and Developmental Toxicology

14 CLINICAL STUDIES

14.1 Patients With Chronic Kidney Disease

14.2 Zidovudine-treated Patients With HIV Infection

14.3 Cancer Patients on Chemotherapy

14.4 Surgery Patients

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

WARNING: 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 EPREX (PROCRIT) dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions (5.1)].

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 [see Table 2, Warnings and Precautions (5.3)].
  • Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense EPREX (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 [see Warnings and Precautions (5.2)].
  • To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see Dosage and Administration (2.4)].
  • Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage (1.3)].
  • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage (1.5)].
  • Discontinue following the completion of a chemotherapy course [see Dosage and Administration (2.4)].

Perisurgery:

  • Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is recommended [see Dosage and Administration (2.5) and Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

1.1 Anemia Due to Chronic Kidney Disease

EPREX (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.

1.2 Anemia Due to Zidovudine in HIV-infected Patients

EPREX (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.

1.3 Anemia Due to Chemotherapy in Patients With Cancer

EPREX (PROCRIT) is indicated for the treatment of anemia in patients with non-myeloid 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.

1.4 Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery

EPREX (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. EPREX (PROCRIT) is not indicated for patients who are willing to donate autologous blood pre-operatively.

1.5 Limitations of Use

EPREX (PROCRIT) has not been shown to improve quality of life, fatigue, or patient well-being.

EPREX (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 [see Clinical Pharmacology (12.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Evaluation of Iron Stores and Nutritional Factors

Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating EPREX (PROCRIT) [see Warnings and Precautions (5.11)].

2.2 Patients with 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. Individualize dosing and use the lowest dose of EPREX (PROCRIT) sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)].

For all patients with CKD:

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 EPREX (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 EPREX (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 EPREX (PROCRIT) if responsiveness does not improve.

For patients with CKD on dialysis:

  • Initiate EPREX (PROCRIT) treatment when the hemoglobin level is less than 10 g/dL.
  • If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of EPREX (PROCRIT).
  • The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 Units/kg 3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.

For patients with CKD not on dialysis:

  • Consider initiating EPREX (PROCRIT) treatment only when the hemoglobin level is less than 10 g/dL and the following considerations apply:
    • The 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 EPREX (PROCRIT), and use the lowest dose of EPREX (PROCRIT) sufficient to reduce the need for RBC transfusions.
  • The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously.

When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.3).

Refer patients who self-administer EPREX (PROCRIT) to the Instructions for Use [see Patient Counseling Information (17)].

2.3 Zidovudine-treated HIV-infected Patients

Starting Dose

The recommended starting dose in adults is 100 Units/kg as an intravenous or subcutaneous injection 3 times per week.

Dose Adjustment

  • If hemoglobin does not increase after 8 weeks of therapy, increase EPREX (PROCRIT) dose by approximately 50 to 100 Units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 Units/kg.
  • Withhold EPREX (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 EPREX (PROCRIT) if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.

2.4 Patients on Cancer Chemotherapy

Initiate EPREX (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 EPREX (PROCRIT) necessary to avoid RBC transfusions.

Recommended Starting Dose

Adults:

  • 150 Units/kg subcutaneously 3 times per week until completion of a chemotherapy course or
  • 40,000 Units subcutaneously weekly until completion of a chemotherapy course.

Pediatric Patients (5 to 18 years):

  • 600 Units/kg intravenously weekly until completion of a chemotherapy course.

Dose Reduction

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.

Dose Increase

After the initial 4 weeks of EPREX (PROCRIT) therapy, if hemoglobin increases by less than 1 g/dL and remains below 10 g/dL, increase dose to:

  • 300 Units/kg three times per week in adults or
  • 60,000 Units weekly in adults
  • 900 Units/kg (maximum 60,000 Units) weekly in children

After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue EPREX (PROCRIT).

2.5 Surgery Patients

The recommended EPREX (PROCRIT) regimens are:

  • 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery.
  • 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery.

Deep venous thrombosis prophylaxis is recommended during EPREX (PROCRIT) therapy [see Warnings and Precautions (5.1)].

2.6 Preparation and Administration

  • Do not shake. Do not use EPREX (PROCRIT) that has been shaken or frozen.
  • Protect vials from light.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any vials exhibiting particulate matter or discoloration.
  • Discard unused portions of EPREX (PROCRIT) in preservative-free vials. Do not re-enter preservative-free vials.
  • Store unused portions of EPREX (PROCRIT) in multidose vials at 36°F to 46°F (2°C to 8°C). Discard 21 days after initial entry.
  • Do not dilute. Do not mix with other drug solutions except for admixing as described below:
    • Preservative-free EPREX (PROCRIT) from single-use vials may be admixed in a syringe with bacteriostatic 0.9% sodium chloride injection, USP, with benzyl alcohol 0.9% (bacteriostatic saline) in a 1:1 ratio using aseptic technique at the time of administration. Risks are associated with benzyl alcohol in neonates, infants, pregnant women, and nursing mothers[see Use in Specific Populations (8.1, 8.3, 8.4)].

3 DOSAGE FORMS AND STRENGTHS

Single-dose vials: 2000, 3000, 4000, 10,000, and 40,000 Units EPREX (PROCRIT) /1 mL

Multidose vials (contains benzyl alcohol): 20,000 Units EPREX (PROCRIT) /2 mL and 20,000 Units EPREX (PROCRIT) /1 mL

4 CONTRAINDICATIONS

EPREX (PROCRIT) is contraindicated in patients with:

  • Uncontrolled hypertension [see Warnings and Precautions (5.4)]
  • Pure red cell aplasia (PRCA) that begins after treatment with EPREX (PROCRIT) or other erythropoietin protein drugs [see Warnings and Precautions (5.7)]
  • Serious allergic reactions to EPREX (PROCRIT) [see Warnings and Precautions (5.8)]

EPREX (PROCRIT) from multidose vials contains benzyl alcohol and is contraindicated in:

  • Neonates, infants, pregnant women, and nursing mothers. Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients. When therapy with EPREX (PROCRIT) is needed in neonates and infants, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol [see Use in Specific Populations (8.1, 8.3,8.4)].

5 WARNINGS AND PRECAUTIONS

5.1 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), EPREX (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[see Clinical Studies (14.1)]. Use caution in patients with coexistent cardiovascular disease and stroke [see Dosage and Administration (2.2)]. 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, EPREX (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.

The design and overall results of the 3 large trials comparing higher and lower hemoglobin targets are shown in Table 1.

Table 1: Randomized Controlled Trials Showing Adverse Cardiovascular Outcomes in Patients With CKD

 

Normal Hematocrit Study (NHS)
(N = 1265)

CHOIR
(N = 1432)

TREAT
(N = 4038)

Time Period of Trial

1993 to 1996

2003 to 2006

2004 to 2009

Population

CKD patients on hemodialysis with coexisting CHF or CAD, hematocrit 30 ± 3% on epoetin alfa

CKD patients not on dialysis with hemoglobin < 11 g/dL not previously administered epoetin alfa

CKD patients not on dialysis with type II diabetes, hemoglobin ≤ 11 g/dL

Hemoglobin Target;
Higher vs. Lower (g/dL)

14.0 vs. 10.0

13.5 vs. 11.3

13.0 vs. ≥ 9.0

Median (Q1, Q3)
Achieved Hemoglobin level (g/dL)

12.6 (11.6, 13.3) vs.
10.3 (10.0, 10.7)

13.0 (12.2, 13.4) vs.
11.4 (11.1, 11.6)

12.5 (12.0, 12.8) vs.
10.6 (9.9, 11.3)

Primary Endpoint

All-cause mortality or non-fatal MI

All-cause mortality, MI, hospitalization for CHF, or stroke

All-cause mortality, MI, myocardial ischemia, heart failure, and stroke

Hazard Ratio or Relative Risk (95% CI)

1.28 (1.06 – 1.56)

1.34 (1.03 – 1.74)

1.05 (0.94 – 1.17)

Adverse Outcome for Higher Target Group

All-cause mortality

All-cause mortality

Stroke

Hazard Ratio or Relative Risk (95% CI)

1.27 (1.04 – 1.54)

1.48 (0.97 – 2.27)

1.92 (1.38 – 2.68)

Patients with Chronic Kidney Disease

Normal Hematocrit Study (NHS): A prospective, randomized, open-label study of 1265 patients with chronic kidney disease on dialysis with documented evidence of congestive heart failure or ischemic heart disease was designed to test the hypothesis that a higher target hematocrit (Hct) would result in improved outcomes compared with a lower target Hct. In this study, patients were randomized to epoetin alfa treatment targeted to a maintenance hemoglobin of either 14 ± 1 g/dL or 10 ± 1 g/dL. The trial was terminated early with adverse safety findings of higher mortality in the high hematocrit target group. Higher mortality (35% vs. 29%) was observed for the patients randomized to a target hemoglobin of 14 g/dL than for the patients randomized to a target hemoglobin of 10 g/dL. For all-cause mortality, the HR = 1.27; 95% CI (1.04, 1.54); p = 0.018. The incidence of nonfatal myocardial infarction, vascular access thrombosis, and other thrombotic events was also higher in the group randomized to a target hemoglobin of 14 g/dL.

CHOIR: A randomized, prospective trial, 1432 patients with anemia due to CKD who were not undergoing dialysis and who had not previously received epoetin alfa therapy were randomized to epoetin alfa treatment targeting a maintenance hemoglobin concentration of either 13.5 g/dL or 11.3 g/dL. The trial was terminated early with adverse safety findings. A major cardiovascular event (death, myocardial infarction, stroke, or hospitalization for congestive heart failure) occurred in 125 of the 715 patients (18%) in the higher hemoglobin group compared to 97 of the 717 patients (14%) in the lower hemoglobin group [hazard ratio (HR) 1.34, 95% CI: 1.03, 1.74; p = 0.03].

TREAT: A randomized, double-blind, placebo-controlled, prospective trial of 4038 patients with: CKD not on dialysis (eGFR of 20 – 60 mL/min), anemia (hemoglobin levels ≤ 11 g/dL), and type 2 diabetes mellitus, patients were randomized to receive either darbepoetin alfa treatment or a matching placebo. Placebo group patients also received darbepoetin alfa when their hemoglobin levels were below 9 g/dL. The trial objectives were to demonstrate the benefit of darbepoetin alfa treatment of the anemia to a target hemoglobin level of 13 g/dL, when compared to a "placebo" group, by reducing the occurrence of either of two primary endpoints: (1) a composite cardiovascular endpoint of all-cause mortality or a specified cardiovascular event (myocardial ischemia, CHF, MI, and CVA) or (2) a composite renal endpoint of all-cause mortality or progression to end stage renal disease. The overall risks for each of the two primary endpoints (the cardiovascular composite and the renal composite) were not reduced with darbepoetin alfa treatment (see Table 1), but the risk of stroke was increased nearly two-fold in the darbepoetin alfa -treated group versus the placebo group: annualized stroke rate 2.1% vs. 1.1%, respectively, HR 1.92; 95% CI: 1.38, 2.68; p < 0.001. The relative risk of stroke was particularly high in patients with a prior stroke: annualized stroke rate 5.2% in the darbepoetin alfa-treated group and 1.9% in the placebo group, HR 3.07; 95% CI: 1.44, 6.54. Also, among darbepoetin alfa-treated subjects with a past history of cancer, there were more deaths due to all causes and more deaths adjudicated as due to cancer, in comparison with the control group.

Patients with Cancer

An increased incidence of thromboembolic reactions, some serious and life-threatening, occurred in patients with cancer treated with ESAs.

In a randomized, placebo-controlled study (Study 1 in Table 2 [see Warnings and Precautions (5.3)]) of 939 women with metastatic breast cancer receiving chemotherapy, patients received either weekly epoetin alfa or placebo for up to a year. This study was designed to show that survival was superior when epoetin alfa was administered to prevent anemia (maintain hemoglobin levels between 12 and 14 g/dL or hematocrit between 36% and 42%). This study was terminated prematurely when interim results demonstrated a higher mortality at 4 months (8.7% vs. 3.4%) and a higher rate of fatal thrombotic reactions (1.1% vs. 0.2%) in the first 4 months of the study among patients treated with epoetin alfa. Based on Kaplan-Meier estimates, at the time of study termination, the 12-month survival was lower in the epoetin alfa group than in the placebo group (70% vs. 76%; HR 1.37, 95% CI: 1.07, 1.75; p = 0.012).

Patients Having Surgery

An increased incidence of deep venous thrombosis (DVT) in patients receiving epoetin alfa undergoing surgical orthopedic procedures was demonstrated [see Adverse Reactions (6.1)]. In a randomized, controlled study, 680 adult patients, not receiving prophylactic anticoagulation and undergoing spinal surgery, were randomized to 4 doses of 600 Units/kg epoetin alfa (7, 14, and 21 days before surgery, and the day of surgery) and standard of care (SOC) treatment (n = 340) or to SOC treatment alone (n = 340). A higher incidence of DVTs, determined by either color flow duplex imaging or by clinical symptoms, was observed in the epoetin alfa group (16 [4.7%] patients) compared with the SOC group (7 [2.1%] patients). In addition to the 23 patients with DVTs included in the primary analysis, 19 [2.8%] patients (n = 680) experienced 1 other thrombovascular event (TVE) each (12 [3.5%] in the epoetin alfa group and 7 [2.1%] in the SOC group). Deep venous thrombosis prophylaxis is strongly recommended when ESAs are used for the reduction of allogeneic RBC transfusions in surgical patients [seeDosage and Administration (2.5)].

Increased mortality was observed in a randomized, placebo-controlled study of EPREX (PROCRIT) in adult patients who were undergoing CABG surgery (7 deaths in 126 patients randomized to EPREX (PROCRIT) versus no deaths among 56 patients receiving placebo). Four of these deaths occurred during the period of study drug administration and all 4 deaths were associated with thrombotic events.

5.2 Prescribing and Distribution Program for EPREX (PROCRIT) in Patients With Cancer

In order to prescribe and/or dispense EPREX (PROCRIT) to patients with cancer and anemia due to myelosuppressive chemotherapy, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program requirements. To enroll, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance. Additionally, prior to each new course of EPREX (PROCRIT) in patients with cancer, prescribers and patients must provide written acknowledgment of a discussion of the risks of EPREX (PROCRIT).

5.3 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 (see Table 2). These findings were observed in studies of patients with advanced head and neck cancer receiving radiation therapy (Studies 5 and 6), in patients receiving chemotherapy for metastatic breast cancer (Study 1) or lymphoid malignancy (Study 2), and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy (Studies 7 and 8).

Table 2. Randomized, Controlled Studies With Decreased Survival and/or Decreased Locoregional Control

Study/Tumor/(n)

Hemoglobin Target

Achieved Hemoglobin
(Median; Q1, Q3*)

Primary Efficacy Outcome

Adverse Outcome for ESA-containing Arm

*Q1= 25th percentile
Q3= 75th percentile

Chemotherapy

Study 1 
Metastatic breast cancer
(n = 939)

12–14 g/dL

12.9 g/dL;
12.2, 13.3 g/dL

12-month overall survival

Decreased 12-month survival

Study 2 
Lymphoid malignancy
(n = 344)

13–15 g/dL (M)
13–14 g/dL (F)

11 g/dL;
9.8, 12.1 g/dL

Proportion of patients achieving a hemoglobin response

Decreased overall survival

Study 3 
Early breast cancer
(n = 733)

12.5–13 g/dL

13.1 g/dL;
12.5, 13.7 g/dL

Relapse-free and overall survival

Decreased 3-year relapse-free and overall survival

Study 4 
Cervical cancer
(n = 114)

12–14 g/dL

12.7 g/dL;
12.1, 13.3 g/dL

Progression-free and overall survival and locoregional control

Decreased 3-year progression-free and overall survival and locoregional control

Radiotherapy Alone

 

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Eprex (PROCRIT) 4000 IU 0.4 mL 6 Prefilled Syringe

  • Product Code: 8699564952935
  • Availability: In Stock
  • $216.00

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