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Procrit (Epoetin alfa)

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  • Product Details

    Description

    Procrit (epoetin alfa) is a recombinant human erythropoietin (rhEPO) indicated to stimulate erythropoiesis (red blood cell production) and treat anemia associated with chronic kidney disease (CKD), zidovudine-treated HIV infection, chemotherapy-induced anemia in cancer patients, and to reduce the need for allogeneic blood transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Epoetin alfa mimics the action of endogenous erythropoietin by stimulating bone marrow erythroid progenitor cells to increase red blood cell count.

    Fact Table

    Formula

    C815H1317N233O241S5 (glycoprotein)

    License

    US FDA (1989), EMA

    Bioavailability

    ~20–30% (subcutaneous)

    Legal status

    Rx-only

    Chemical Name

    Epoetin alfa (recombinant human erythropoietin)

    Elimination half-life

    ~4–13 hours (IV); ~24 hours (SC)

    Dosage (Strength)

    1,000 to 40,000 units/mL (SC or IV)

    Pregnancy

    Category C – use only if clearly needed

    Brands

    Procrit, Epogen, Eprex

    Protein binding

    Negligible

    PubChem CID

    16132297

    MedlinePlus

    a601103

    ChEBI

    37974

    ATC code

    B03XA01

    DrugBank

    DB00016

    KEGG

    D02935

    Routes of administration

    Intravenous, Subcutaneous

    Directions

    Procrit is administered intravenously (IV) or subcutaneously (SC) depending on the clinical setting. Dosing varies by indication and is individualized based on hemoglobin levels and response:

    • CKD (non-dialysis): Initiate at 50–100 units/kg three times weekly or once weekly
    • CKD (dialysis): Initiate at 50–100 units/kg three times weekly
    • Chemotherapy-induced anemia: 150 units/kg SC three times weekly or 40,000 units SC weekly
    • Zidovudine-treated HIV patients: 100 units/kg SC or IV three times weekly
    • Elective surgery: 300 units/kg/day SC for 10 days before surgery, on day of surgery, and 4 days after

    Dose adjustments are made to maintain the lowest hemoglobin level sufficient to avoid transfusion (typically not to exceed 11 g/dL in CKD). Hemoglobin should be monitored at least weekly during initiation.

    Ingredients

    Each mL of Procrit solution contains:

    • Epoetin alfa (varies by presentation: 2,000 to 40,000 Units/mL)
    • Sodium chloride
    • Albumin (human)
    • Citrate buffer
    • Polysorbate 80
    • Water for injection

    The solution is preservative-free in single-dose vials and may contain benzyl alcohol in multidose vials.

    Contraindications

    Procrit is contraindicated in patients with:

    • Uncontrolled hypertension
    • Known hypersensitivity to epoetin alfa, albumin, or mammalian cell–derived products
    • Pure red cell aplasia (PRCA) following prior treatment with erythropoiesis-stimulating agents (ESAs)
    • Use in surgical patients not receiving adequate prophylaxis for deep venous thrombosis (DVT)

    Cautions

    • Procrit carries a boxed warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and tumor progression in certain patient populations.
    • Use the lowest effective dose to reduce transfusion risk.
    • In CKD patients, higher hemoglobin targets are associated with greater cardiovascular events.
    • In cancer patients, ESAs may shorten overall survival and increase tumor progression; use only in those receiving palliative chemotherapy.
    • Monitor blood pressure closely during therapy.
    • Evaluate for iron deficiency and correct prior to or during treatment.

    Side Effects

    Common side effects include:

    • Hypertension
    • Headache
    • Arthralgia
    • Nausea
    • Fever
    • Fatigue
    • Edema
    • Diarrhea
    • Dizziness

    Serious adverse effects include:

    • Cardiovascular events (MI, stroke)
    • Thromboembolic events
    • Seizures
    • Pure red cell aplasia (rare)
    • Serious allergic reactions (anaphylaxis, angioedema)

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 5509

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