Generic Name
Epoetin
Brand Names
Procrit, Epogen, Retacrit
FDA approval date: June 01, 1989
Classification: Erythropoiesis-stimulating Agent
Form: Injection, Solution
What is Procrit (Epoetin)?
Epogen is an erythropoiesis-stimulating agent indicated for: Treatment of anemia due to: - Chronic Kidney Disease in patients on dialysis and not on dialysis.
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Brand Information
PROCRIT (Erythropoietin)
1DOSAGE 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)
2CONTRAINDICATIONS
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 multiple-dose vials contains benzyl alcohol and is contraindicated in:
- Neonates, infants, pregnant women, and lactating women
3ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the label:
- Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism
- Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer
- Hypertension
- Seizures
- PRCA
- Serious Allergic Reactions
- Severe Cutaneous Reactions
3.1Clinical 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.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of PROCRIT.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Seizures
- PRCA
- Serious Allergic Reactions
- Injection Site Reactions, including irritation and pain
- Porphyria
- Severe Cutaneous Reactions
3.3Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to epoetin alfa with the incidence of antibodies to other products may be misleading.
Neutralizing antibodies to epoetin alfa that cross-react with endogenous erythropoietin and other ESAs can result in PRCA or severe anemia (with or without other cytopenias)
4OVERDOSAGE
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
5DESCRIPTION
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).
6HOW 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.
7PATIENT 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
- 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
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.
8PRINCIPAL DISPLAY PANEL - 2,000 Unit Vial Carton
2,000 Units/mL
NDC 59676 -302-01
6-1 mL Single-dose vials
6-1 mL Single-dose vials
PROCRIT
2,000 Units/mL
2,000 Units/mL
For Intravenous or Subcutaneous Use Only
Sterile Solution — No Preservative
Sterile Solution — No Preservative
Attention: Dispense the enclosed Medication Guide to each patient.
Each 1 mL vial contains: 2,000 units of recombinant epoetin alfa and
Rx only
9PRINCIPAL DISPLAY PANEL - 3,000 Unit Vial Carton
3,000 Units/mL
NDC59676 -303-01
6-1 mL Single-dose vials
6-1 mL Single-dose vials
PROCRIT
3,000 Units/mL
3,000 Units/mL
For Intravenous or Subcutaneous Use Only
Sterile Solution — No Preservative
Sterile Solution — No Preservative
Attention: Dispense the enclosed Medication Guide to each patient.
Each 1 mL vial contains: 3,000 units of recombinant epoetin alfa and
Rx only
10PRINCIPAL DISPLAY PANEL - 4,000 Unit Vial Carton
4,000 Units/mL
NDC59676 -304-01
6-1 mL Single-dose vials
6-1 mL Single-dose vials
PROCRIT
4,000 Units/mL
4,000 Units/mL
For Intravenous or Subcutaneous Use Only
Sterile Solution — No Preservative
Sterile Solution — No Preservative
Attention: Dispense the enclosed Medication Guide to each patient.
Each 1 mL vial contains: 4,000 units of recombinant epoetin alfa and
Rx only
11PRINCIPAL DISPLAY PANEL - 10,000 Unit Vial Carton
10,000 Units/mL
NDC59676 -310-01
6-1 mL Single-dose vials
6-1 mL Single-dose vials
PROCRIT
10,000 Units/mL
10,000 Units/mL
For Intravenous or Subcutaneous Use Only
Sterile Solution — No Preservative
Sterile Solution — No Preservative
Attention: Dispense the enclosed Medication Guide to each patient.
Each 1 mL vial contains: 10,000 units of recombinant epoetin alfa and
Rx only
12PRINCIPAL DISPLAY PANEL - 40,000 Unit Vial Carton
40,000 Units/mL
NDC59676 -340-01
4-1 mL Single-dose vials
4-1 mL Single-dose vials
PROCRIT
40,000 Units/mL
40,000 Units/mL
For Intravenous or Subcutaneous Use Only
Sterile Solution — No Preservative
Sterile Solution — No Preservative
Attention: Dispense the enclosed Medication Guide to each patient.
Each 1 mL vial contains: 40,000 units of recombinant
Rx only
13PRINCIPAL DISPLAY PANEL - 20,000 Units/2 mL Multiple-dose Vial Carton
PRINCIPAL DISPLAY PANEL - 20,000 Units/2 mL Vial Carton
20,000 Units/2 mL
NDC59676- 312-04
4-2 mL Multiple-dose Vials
4-2 mL Multiple-dose Vials
PROCRIT
20,000 Units/2 mL (10,000 Units/mL)
Multiple-dose Vials
Sterile solution — Preserved. 10,000 Units/mL
Attention: Dispense the enclosed Medication Guide to each patient.
2 mL
Rx only
14PRINCIPAL DISPLAY PANEL - 20,000 Units/mL Multiple-dose Vial Carton
PRINCIPAL DISPLAY PANEL - 20,000 Unit Vial Carton
20,000 Units/mL
NDC59676- 320-04
4-1 mL Multiple-dose Vials
4-1 mL Multiple-dose Vials
PROCRIT
20,000 Units/mL
Multiple-dose Vials
Sterile solution — Preserved. 20,000 Units/mL
Attention: Dispense the enclosed Medication Guide to each patient.
1 mL
Rx only
