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PROCRIT Erythropoietin 40000 [iU]/mL Injection, Solution, 4 vials
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Erythropoiesis-stimulating Agent class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Epoetin alfa injection products are used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time). Epoetin alfa injection products are also used to treat anemia caused by chemotherapy in people with certain types of cancer or caused by zidovudine (AZT, Retrovir, in Trizivir, in Combivir), a medication used to treat human immunodeficiency virus (HIV). Epoetin alfa injection products are also used before and after certain types of surgery to decrease the chance...
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Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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2.5 mg / 1 mL
UNII ZIF514RVZR
A protein derived from human blood plasma. In medicines, it acts as a stabilizer and binder, helping maintain drug potency and form, and may improve how the medication disperses or dissolves in the body.
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6.8 ug / 1 mL
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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5.8 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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0.7 mg / 1 mL
UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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1.8 mg / 1 mL
UNII 22ADO53M6F
A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
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1.2 mg / 1 mL
UNII 593YOG76RN
A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1,036.210 | $4,144.84 / 4 ml |
| Medicaid paysCMS SDUD · 12 mo | $560.18 | $2,240.74 / 4 ml |
| Medicare drug plans payPart D · Q2 2026 | $1,051.90 | $4,207.58 / 4 ml |
| Medicare Part B allowsASP · J0885 | $6.876 / J0885 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Procrit 40000 [iU]/mLthis 59676-0340-01 | Janssen | 4 vials | $1,036.210 | — | Availability likely | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59676-0340-01 You're viewing this | 4 VIAL, SINGLE-DOSE in 1 CARTON (59676-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE (59676-340-00) | 1989-06-01 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. 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 ( 5.1 ).
No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks ( 2.2 ). Use the lowest PROCRIT dose sufficient to reduce the need for red blood cell (RBC) transfusions ( 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 ( 5.2 ).
Use the lowest dose to avoid RBC transfusions ( 2.4 ). Use ESAs only for anemia from myelosuppressive chemotherapy ( 1.3 ). ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.5 ).
Discontinue following the completion of a chemotherapy course ( 2.4 ). Perisurgery: Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended ( 5.1 ). Chronic Kidney Disease: In controlled trials, patients with chronic kidney disease (CKD) 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 [see Warnings and Precautions (5.1) ] .
No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks [see Dosage and Administration (2.2) ] . Use the lowest 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 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) , Warnings and Precautions (5.1) ] .
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE PROCRIT is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ).
Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery ( 1.4 ). Limitations of Use PROCRIT has not been shown to improve quality of life, fatigue, or patient well-being ( 1.5 ). PROCRIT is not indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy ( 1.5 ).
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.5 ). In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion ( 1.5 ). In patients scheduled for surgery who are willing to donate autologous blood ( 1.5 ).
In patients undergoing cardiac or vascular surgery ( 1.5 ). As a substitute for RBC transfusions in patients who require immediate correction of anemia ( 1.5 ).
1.1Anemia 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.
1.2Anemia Due to Zidovudine in Patients with HIV Infection PROCRIT is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in patients with HIV Infection with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL.
1.3Anemia Due to Chemotherapy in Patients with Cancer 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.
1.4Reduction 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.
1.5Limitations of Use 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 with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. 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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Evaluate iron status before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia before initiating treatment ( 2.1 ). In pregnant women, lactating women, neonates, infants: Use only single-dose vials ( 2.1 ).
Patients with CKD: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (pediatric patients). Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis ( 2.2 ).
Patients on Zidovudine due to HIV Infection: 100 Units/kg 3 times weekly ( 2.3 ). Patients with Cancer on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (pediatric patients ≥ 5 years) ( 2.4 ). Surgery Patients: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly ( 2.5 ).
2.1Important Dosing Information Evaluation of Iron Stores and Nutritional Factors Evaluate the iron status in all patients before and during 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.
Monitoring of Response to Therapy Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating PROCRIT. 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. Selection of Formulation In pregnant women, lactating women, neonates, and infants use only single-dose vials (the benzyl alcohol-free formulation) [see Contraindications (4) and Use in Specific Populations (8.1 , 8.2 , and 8.4) ].
2.2Patients with Chronic Kidney Disease In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered 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 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 reactions [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 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. For adult patients with CKD on dialysis: Initiate 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 PROCRIT.
The recommended starting dose for adult patients is 50 to 100…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of PROCRIT as a clear and colorless liquid in single-dose vials 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of PROCRIT as a clear and colorless liquid in multiple-dose vials (contains benzyl alcohol) Injection 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL in single-dose vials ( 3 ) 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL in multiple-dose vials containing benzyl alcohol ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS PROCRIT is contraindicated in patients with: Uncontrolled hypertension [see Warnings and Precautions (5.3) ] Pure red cell aplasia (PRCA) that begins after treatment with PROCRIT or other erythropoietin protein drugs [see Warnings and Precautions (5.6) ] Serious allergic reactions to PROCRIT [see Warnings and Precautions (5.7) ] PROCRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: Neonates, infants, pregnant women, and lactating women [see Warnings and Precautions (5.9) , Use in Specific Populations (8.1 , 8.2 , 8.4) ].
Uncontrolled hypertension ( 4 ) Pure red cell aplasia (PRCA) that begins after treatment with PROCRIT or other erythropoietin protein drugs ( 4 ) Serious allergic reactions to PROCRIT ( 4 ) Use of the multiple-dose vials containing benzyl alcohol in neonates, infants, pregnant women, and lactating women ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: 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 ( 5.1 and 14.1 ). Use caution in patients with coexistent cardiovascular disease and stroke ( 5.1 ). Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer ( 5.2 ).
Hypertension: Control hypertension prior to initiating and during treatment with PROCRIT ( 5.3 ). Seizures: PROCRIT increases the risk for seizures in patients with CKD ( 5.4 ). Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms ( 5.4 ).
PRCA: If severe anemia and low reticulocyte count develop during PROCRIT treatment, withhold PROCRIT and evaluate for PRCA ( 5.6 ). Serious Allergic Reactions: Discontinue PROCRIT and manage reactions ( 5.7 ). Severe Cutaneous Reactions: Discontinue PROCRIT ( 5.8 ).
5.1Increased 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 [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, 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. ≥
9.0Median (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 dialys…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions (5.1) ] Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer [see Warnings and Precautions (5.2) ] Hypertension [see Warnings and Precautions (5.3) ] Seizures [see Warnings and Precautions (5.4) ] PRCA [see Warnings and Precautions (5.6) ] Serious Allergic Reactions [see Warnings and Precautions (5.7) ] Severe Cutaneous Reactions [see Warnings and Precautions (5.8) ] Patients with CKD: Adverse reactions in ≥ 5% of PROCRIT-treated patients in clinical studies were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection ( 6.1 ).
Patients on Zidovudine due to HIV Infection: Adverse reactions in ≥ 5% of PROCRIT-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation ( 6.1 ). Patients with Cancer on Chemotherapy: 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 ( 6.1 ). Surgery Patients: 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 ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. Patients with Chronic Kidney Disease Adult Patients Three double-blind, placebo-controlled studies, including 244 patients with CKD on dialysis, were used to identify the adverse reactions to PROCRIT. In these studies, the mean age of patients was 48 years (range: 20 to 80 years).
One hundred and thirty-three (55%) patients were men. The racial distribution was as follows: 177 (73%) patients were white, 48 (20%) patients were black, 4 (2%) patients were Asian, 12 (5%) patients were other, and racial information was missing for 3 (1%) patients. Two double-blind, placebo-controlled studies, including 210 patients with CKD not on dialysis, were used to identify the adverse reactions to PROCRIT.
In these studies, the mean age of patients was 57 years (range: 24 to 79 years). One hundred and twenty-one (58%) patients were men. The racial distribution was as follows: 164 (78%) patients were white, 38 (18%) patients were black, 3 (1%) patients were Asian, 3 (1%) patients were other, and racial information was missing for 2 (1%) patients.
The adverse reactions with a reported incidence of ≥ 5% in PROCRIT-treated patients and that occurred at a ≥ 1% higher frequency than in placebo-treated patients are shown in the table below: Table 3: Adverse Reactions in Patients with CKD on Dialysis Adverse Reaction PROCRIT-treated Patients (n=148) Placebo-treated Patients (n=96) Hypertension 27.7% 12.5% Arthralgia 16.2% 3.1% Muscle spasm 7.4% 6.3% Pyrexia 10.1% 8.3% Dizziness 9.5% 8.3% Medical Device Malfunction (artificial kidney clotting during dialysis) 8.1% 4.2% Vascular Occlusion (vascular access thrombosis) 8.1% 2.1% Upper respiratory tract infection 6.8% 5.2% An additional serious adverse reaction that occurred in less than 5% of epoetin alfa-treated dialysis patients and greater than placebo was thrombosis (2.7% PROCRIT and 1% placebo) [see Warnings and Precautions (5.1) ].
The adverse reactions with a reported incide…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary PROCRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women [see Contraindications (4) ] . When therapy with PROCRIT is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial). Do not mix PROCRIT with bacteriostatic saline when administering to pregnant women because it contains benzyl alcohol (see Clinical Considerations ) [see Dosage and Administration (2.1) ] .
The limited available data on PROCRIT use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproductive and developmental toxicity studies, adverse fetal effects including embryo-fetal death, skeletal anomalies, and growth defects occurred when pregnant rats received epoetin alfa at doses approximating the clinical recommended starting doses (see Data ) . Consider the benefits and risks of PROCRIT single-dose vials for the mother and possible risks to the fetus when prescribing PROCRIT to a pregnant woman.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions The multiple-dose vials of PROCRIT contain benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse reactions and death when administered intravenously to neonates and infants [see Warnings and Precautions (5.9) , Use in Specific Populations (8.4) ]. There is a potential for similar risks to fetuses exposed to benzyl alcohol in utero .
Data Human Data There are reports of pregnant women with anemia alone or anemia associated with severe renal disease and other hematologic disorders who received PROCRIT. Polyhydramnios and intrauterine growth restriction were reported in women with chronic renal disease, which is associated with an increased risk for these adverse pregnancy outcomes. Due to the limited number of exposed pregnancies and multiple confounding factors (such as underlying maternal conditions, other maternal medications, and gestational timing of exposure), these published case reports and studies do not reliably estimate the frequency, presence or absence of adverse outcomes.
Animal Data When rats received PROCRIT at doses greater than or equal to 100 Units/kg/day during mating and through early pregnancy (dosing stopped prior to organogenesis), there were slight increases in the incidences of pre- and post-implantation loss, and a decrease in live fetuses in the presence of maternal toxicity (red limbs/pinna, focal splenic capsular toxicity, increased organ weights). This animal dose level of 100 Units/kg/day may approximate the clinical recommended starting dose, depending on the treatment indication.
When pregnant rats and rabbits received intravenous doses of up to 500 mg/kg/day of PROCRIT only during organogenesis (gestational days 7 to 17 in rats and gestational days 6 to 18 in rabbits), no teratogenic effects were observed in the offspring. The offspring (F1 generation) of the treated rats were observed postnatally; rats from the F1 generation reached maturity and were mated; no PROCRIT-related effects were apparent for their offspring (F2 generation fetuses). When pregnant rats received PROCRIT at doses of 500 Units/kg/day late in pregnancy (after the period of organogenesis from day 17 of gestation through day 21 of lactation), pups exhibited decreased number of caudal vertebrae, decreased body weight gain, and delayed appearance of abdominal hair, eyelid opening, and ossification in the presence of maternal toxicity (red limbs/pinna, increased organ weights).
This animal dose level of 500 U/kg/day is…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary PROCRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women [see Contraindications (4) ] . When therapy with PROCRIT is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial). Do not mix PROCRIT with bacteriostatic saline when administering to pregnant women because it contains benzyl alcohol (see Clinical Considerations ) [see Dosage and Administration (2.1) ] .
The limited available data on PROCRIT use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproductive and developmental toxicity studies, adverse fetal effects including embryo-fetal death, skeletal anomalies, and growth defects occurred when pregnant rats received epoetin alfa at doses approximating the clinical recommended starting doses (see Data ) . Consider the benefits and risks of PROCRIT single-dose vials for the mother and possible risks to the fetus when prescribing PROCRIT to a pregnant woman.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions The multiple-dose vials of PROCRIT contain benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse reactions and death when administered intravenously to neonates and infants [see Warnings and Precautions (5.9) , Use in Specific Populations (8.4) ]. There is a potential for similar risks to fetuses exposed to benzyl alcohol in utero .
Data Human Data There are reports of pregnant women with anemia alone or anemia associated with severe renal disease and other hematologic disorders who received PROCRIT. Polyhydramnios and intrauterine growth restriction were reported in women with chronic renal disease, which is associated with an increased risk for these adverse pregnancy outcomes. Due to the limited number of exposed pregnancies and multiple confounding factors (such as underlying maternal conditions, other maternal medications, and gestational timing of exposure), these published case reports and studies do not reliably estimate the frequency, presence or absence of adverse outcomes.
Animal Data When rats received PROCRIT at doses greater than or equal to 100 Units/kg/day during mating and through early pregnancy (dosing stopped prior to organogenesis), there were slight increases in the incidences of pre- and post-implantation loss, and a decrease in live fetuses in the presence of maternal toxicity (red limbs/pinna, focal splenic capsular toxicity, increased organ weights). This animal dose level of 100 Units/kg/day may approximate the clinical recommended starting dose, depending on the treatment indication.
When pregnant rats and rabbits received intravenous doses of up to 500 mg/kg/day of PROCRIT only during organogenesis (gestational days 7 to 17 in rats and gestational days 6 to 18 in rabbits), no teratogenic effects were observed in the offspring. The offspring (F1 generation) of the treated rats were observed postnatally; rats from the F1 generation reached maturity and were mated; no PROCRIT-related effects were apparent for their offspring (F2 generation fetuses). When pregnant rats received PROCRIT at doses of 500 Units/kg/day late in pregnancy (after the period of organogenesis from day 17 of gestation through day 21 of lactation), pups exhibited decreased number of caudal vertebrae, decreased body weight gain, and delayed appearance of abdominal hair, eyelid opening, and ossification in the presence of maternal toxicity (red limbs/pinna, increased organ weights).
This animal dose level of 500 U/kg/day is approximately five times the…
🧒 Pediatric Use ▾
8.4Pediatric Use The multiple-dose vials are formulated with benzyl alcohol and are contraindicated for use in neonates and infants [see Contraindications (4) , Warnings and Precautions (5.9) ] . When therapy with PROCRIT is needed in neonates and infants, use the single-dose vial, which is a benzyl alcohol-free formulation. Do not mix the single-dose vials with bacteriostatic saline when administering PROCRIT to neonates or infants because it contains benzyl alcohol [see Dosage and Administration (2.6) ] .
Serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.
Preterm, low birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Warnings and Precautions (5.9) ] . Pediatric Patients with CKD PROCRIT is indicated in pediatric patients, ages 1 month to 16 years of age, for the treatment of anemia associated with CKD requiring dialysis.
Safety and effectiveness in pediatric patients less than 1 month old have not been established [see Clinical Studies (14.1) ] . Use of PROCRIT in pediatric patients with CKD not requiring dialysis is supported by efficacy in pediatric patients requiring dialysis. The mechanism of action of PROCRIT is the same for these two populations.
Published literature also has reported the use of PROCRIT in pediatric patients with CKD not requiring dialysis. Dose-dependent increases in hemoglobin and hematocrit were observed with reductions in transfusion requirements. The safety data from the pediatric studies and postmarketing reports are similar to those obtained from the studies of PROCRIT in adult patients with CKD [see Warnings and Precautions (5) and Adverse Reactions (6.1) ] .
Postmarketing reports do not indicate a difference in safety profiles in pediatric patients with CKD requiring dialysis and not requiring dialysis. Pediatric Patients with Cancer on Chemotherapy PROCRIT is indicated in patients 5 to 18 years old for the treatment of anemia due to concomitant myelosuppressive chemotherapy. Safety and effectiveness in pediatric patients less than 5 years of age have not been established [see Clinical Studies (14.3) ].
The safety data from these studies are similar to those obtained from the studies of PROCRIT in adult patients with cancer [see Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ]. Pediatric Patients with HIV Infection Receiving Zidovudine Published literature has reported the use of PROCRIT in 20 zidovudine-treated, anemic, pediatric patients with HIV Infection, ages 8 months to 17 years, treated with 50 to 400 Units/kg subcutaneously or intravenously 2 to 3 times per week. Increases in hemoglobin levels and in reticulocyte counts and decreases in or elimination of RBC transfusions were observed.
Pharmacokinetics in Neonates Limited pharmacokinetic data from a study of 7 preterm, very low birth weight neonates and 10 healthy adults given intravenous erythropoietin suggested that distribution volume was approximately 1.5 to 2 times higher in the preterm neonates than in the healthy adults, and clearance was approximately 3 times higher in the preterm neonates than in the healthy adults.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 4553 patients who received PROCRIT in the 6 studies for treatment of anemia due to CKD not receiving dialysis, 2726 (60%) were age 65 years and over, while 1418 (31%) were 75 years and over. Of the 757 patients who received PROCRIT in the 3 studies of CKD patients on dialysis, 361 (47%) were age 65 years and over, while 100 (13%) were 75 years and over. No differences in safety or effectiveness were observed between geriatric and younger patients.
Dose selection and adjustment for an elderly patient should be individualized to achieve and maintain the target hemoglobin [see Dosage and Administration (2) ] . Among 778 patients enrolled in the 3 clinical studies of PROCRIT for the treatment of anemia due to concomitant chemotherapy, 419 received PROCRIT and 359 received placebo. Of the 419 who received PROCRIT, 247 (59%) were age 65 years and over, while 78 (19%) were 75 years and over.
No overall differences in safety or effectiveness were observed between geriatric and younger patients. The dose requirements for PROCRIT in geriatric and younger patients within the 3 studies were similar. Among 1731 patients enrolled in the 6 clinical studies of PROCRIT for reduction of allogeneic RBC transfusions in patients undergoing elective surgery, 1085 received PROCRIT and 646 received placebo or standard of care treatment.
Of the 1085 patients who received PROCRIT, 582 (54%) were age 65 years and over, while 245 (23%) were 75 years and over. No overall differences in safety or effectiveness were observed between geriatric and younger patients. The dose requirements for PROCRIT in geriatric and younger patients within the 4 studies using the 3 times weekly schedule and 2 studies using the weekly schedule were similar.
Insufficient numbers of patients age 65 years or older were enrolled in clinical studies of PROCRIT for the treatment of patients treated with zidovudine for HIV Infection to determine whether they respond differently from younger patients .
🆘 Overdosage ▾
10 OVERDOSAGE PROCRIT overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of PROCRIT dosage and/or with phlebotomy, as clinically indicated [see Clinical Pharmacology (12.2) ] . Cases of severe hypertension have been observed following overdose with ESAs [see Warnings and Precautions (5.3) ].
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action PROCRIT stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.
12.2Pharmacodynamics PROCRIT increases the reticulocyte count within 10 days of initiation, followed by increases in the RBC count, hemoglobin, and hematocrit, usually within 2 to 6 weeks. The rate of hemoglobin increase varies among patients and is dependent upon the dose of PROCRIT administered. For correction of anemia in hemodialysis patients, a greater biologic response is not observed at doses exceeding 300 Units/kg 3 times weekly.
12.3Pharmacokinetics In adult and pediatric patients with CKD, the elimination half-life (t 1/2 ) of plasma erythropoietin after intravenous administration of PROCRIT ranged from 4 to 13 hours. After subcutaneous administration, C max was achieved within 5 to 24 hours. The t 1/2 in adult patients with serum creatinine greater than 3 mg/dL was similar between those not on dialysis and those maintained on dialysis.
The pharmacokinetic data indicate no apparent difference in PROCRIT t 1/2 among adult patients above or below 65 years of age. A pharmacokinetic study comparing 150 Units/kg subcutaneous 3 times weekly to 40,000 Units subcutaneous weekly dosing regimen was conducted for 4 weeks in healthy subjects (n=12) and for 6 weeks in anemic cancer patients (n=32) receiving cyclic chemotherapy. There was no accumulation of serum erythropoietin after the 2 dosing regimens during the study period.
The 40,000 Units weekly regimen had a higher C max (3- to 7-fold), longer T max (2- to 3-fold), higher AUC 0–168 h (2- to 3-fold) of erythropoietin and lower clearance (CL) (50%) than the 150 Units/kg 3 times weekly regimen. In anemic cancer patients, the average t 1/2 was similar (40 hours with range of 16 to 67 hours) after both dosing regimens. After the 150 Units/kg 3 times weekly dosing, the values of T max and CL were similar (13.3 ± 12.4 vs.
14.2± 6.7 hours, and 20.2 ± 15.9 vs. 23.6 ± 9.5 mL/hr/kg) between week 1 when patients were receiving chemotherapy (n=14) and week 3 when patients were not receiving chemotherapy (n=4). Differences were observed after the 40,000 Units weekly dosing with longer T max (38 ± 18 hours) and lower CL (9.2 ± 4.7 mL/hr/kg) during week 1 when patients were receiving chemotherapy (n=18) compared with those (22 ± 4.5 hours, 13.9 ± 7.6 mL/hr/kg, respectively) during week 3 when patients were not receiving chemotherapy (n=7).
The pharmacokinetic profile of PROCRIT in pediatric patients appeared similar to that of adults. The pharmacokinetics of PROCRIT has not been studied in patients with HIV Infection.
🧬 Mechanism of Action ▾
12.1Mechanism of Action PROCRIT stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING PROCRIT (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation) : 2,000 Units/mL (NDC 59676-302-01), 3,000 Units/mL (NDC 59676-303-01), 4,000 Units/mL (NDC 59676-304-01), or 10,000 Units/mL (NDC 59676-310-01) supplied in cartons, each carton containing six 1 mL single-dose vials. Preservative-free, single-dose vials (in citrate-buffered formulation) : 10,000 Units/mL (NDC 59676-310-02) supplied in dispensing packs (tray) containing 25 single-dose 1 mL vials.
Preservative-free, single-dose vials (in phosphate-buffered formulation) : 40,000 Units/mL (NDC 59676-340-01) supplied in dispensing packs containing four 1 mL single-dose vials. Preserved, multiple-dose vials : 20,000 Units/2mL (10,000 Units/mL) (NDC 59676-312-04) supplied in dispensing packs containing four 2 mL multiple-dose vials. Preserved, multiple-dose vials : 20,000 Units/mL (NDC 59676-320-04) supplied in dispensing packs containing four 1 mL multiple-dose vials.
Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake.
Do not use PROCRIT that has been shaken or frozen. Store PROCRIT vials in the original carton until use to protect from light.
📦 Storage and Handling ▾
Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Do not use PROCRIT that has been shaken or frozen. Store PROCRIT vials in the original carton until use to protect from light.
📋 Description ▾
11 DESCRIPTION Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin.
PROCRIT (epoetin alfa) injection for intravenous or subcutaneous administration is formulated as a sterile, clear, colorless liquid in vials in multiple formulations. Single-dose vials, formulated with an isotonic sodium chloride/sodium citrate-buffered solution, are supplied in multiple strengths. Each single-dose 1 mL vial contains 2,000, 3,000, 4,000, or 10,000 Units of epoetin alfa, Albumin (Human) (2.5 mg), citric acid (0.06 mg), sodium chloride (5.9 mg), and sodium citrate (5.8 mg) in Water for Injection, USP (pH 6.9 ± 0.3).
Single-dose 1 mL vials formulated with an isotonic sodium chloride/sodium phosphate buffer contain 40,000 Units of epoetin alfa albumin (human) (2.5 mg), citric acid (0.0068 mg), sodium chloride (5.8 mg), sodium citrate (0.7 mg), sodium phosphate dibasic anhydrate (1.8 mg), and sodium phosphate monobasic monohydrate (1.2 mg) in Water for Injection, USP (pH 6.9 ± 0.3). Multiple-dose, 2 mL vials contain 10,000 Units epoetin alfa, albumin (human) (2.5 mg), benzyl alcohol (1%), sodium chloride (8.2 mg), citric acid (0.11 mg), and sodium citrate (1.3 mg) per 1 mL Water for Injection, USP (pH 6.1 ± 0.3).
Multiple-dose 1 mL vials contain 20,000 Units epoetin alfa, albumin (human) (2.5 mg), benzyl alcohol (1%), sodium chloride (8.2 mg), citric acid (0.11 mg), and sodium citrate (1.3 mg), per 1 mL in Water for Injection, USP (pH 6.1 ± 0.3).
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Inform patients: Of the increased risks of mortality, serious cardiovascular reactions, thromboembolic reactions, stroke, and tumor progression [see Warnings and Precautions (5.1 , 5.2) ] . To undergo regular blood pressure monitoring, adhere to prescribed anti-hypertensive regimen and follow recommended dietary restrictions.
To contact their healthcare provider for new-onset neurologic symptoms or change in seizure frequency. Of the need to have regular laboratory tests for hemoglobin. Risks are associated with benzyl alcohol in neonates, infants, pregnant women, and lactating women [see Use in Specific Populations (8.1 , 8.2 , 8.4) ].
Instruct patients who self-administer PROCRIT of the: Importance of following the Instructions for Use. Dangers of reusing needles, syringes, or unused portions of single-dose vials. Proper disposal of used syringes, needles, and unused vials, and of the full container.
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 04/2024 MEDICATION GUIDE PROCRIT ® (PRO'–KRIT) (epoetin alfa) Read this Medication Guide: before you start PROCRIT. if you are told by your healthcare provider that there is new information about PROCRIT. if you are told by your healthcare provider that you may inject PROCRIT at home, read this Medication Guide each time you receive a new supply of medicine.
This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Talk with your healthcare provider regularly about the use of PROCRIT and ask if there is new information about PROCRIT. What is the most important information I should know about PROCRIT?
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 will talk with you about these risks. For all people who take PROCRIT, including people 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. Blood 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 See " What are the possible side effects of PROCRIT? " below for more information.
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 RBC transfusions. What is PROCRIT? PROCRIT is a prescription medicine used to treat anemia.
People with anemia have a lower-than-normal number of RBCs. PROCRIT works like the human protein called erythropoietin to help your body make more RBCs. PROCRIT is used to reduce or avoid the need for RBC transfusions.
PROCRIT may be used to treat anemia if it is caused by: Chronic kidney disease (you may or may not be on dialysis). Chemotherapy that will be used for at least two 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 RBC transfusions if you are scheduled for certain surgeries where a lot of blood loss is expected. If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take PROCRIT, even if you do not have an increase in your hemoglobin level.
PROCRIT has not been proven to improve quality of life, fatigue, or well-being. PROCRIT should not be used for treatment of anemia: If you have cancer and you will not be receiving chemotherapy that may cause anemia. If you have a cancer that has a high chance of being cured.
Talk with your healthcare provider about the kind of cancer you have. If your anemia caused by chemothe…