PRODUCT DESCRIPTION:

Erythropoietin Injection is a recombinant human erythropoietin (rHuEPO) used to stimulate red blood cell production in patients with anemia due to chronic kidney disease, chemotherapy, HIV therapy, or elective orthopedic surgery.

This biological therapy mimics the natural hormone produced by the kidneys and is a critical intervention for managing anemia without the need for frequent transfusions.

Offered in precision-filled, sterile Pre-Filled Syringes (PFS), this formulation is manufactured under stringent cold-chain protocols and conforms to global GMP and biosimilar regulatory standards.

Formulation & Presentation:

• Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
• Presentation: Pre-Filled Syringe (customizable as per market demand)
• Available Strengths:
  • 2000 IU/ ML (Pre-Filled Syringe)
  • 3000 IU/ ML (Pre-Filled Syringe)
  • 4000 IU/ ML (Pre-Filled Syringe)
  • 5000 IU/ ML (Pre-Filled Syringe)
  • 20000 IU/ ML (Pre-Filled Syringe)
  • 40000 IU/ ML (Pre-Filled Syringe)
• Route of Administration: Subcutaneous (SC)/ Intravenous (IV) To be used only in advanced clinical settings, as per clinical indication and severity. To be administered under supervision of a qualified specialist only. (As per physician’s discretion or decision)

Therapeutic Indications:

• Anemia associated with chronic kidney disease (CKD) in both dialysis and non-dialysis patients
• Anemia due to chemotherapy in cancer patients
• Anemia in HIV-infected patients receiving zidovudine
• Reduction of allogeneic blood transfusion in elective orthopedic surgery
• Off-label support in critically ill patients where erythropoiesis is compromised

Side Effects:

• COMMON:
  • Injection site irritation or redness
  • Headache, joint pain
  • Increased blood pressure (hypertension)
  • Flu-like symptoms
• SERIOUS (RARE):
  • Thromboembolic events (e.g., stroke, DVT)
  • Pure red cell aplasia (PRCA) due to anti-EPO antibodies
  • Seizures (particularly in patients with uncontrolled hypertension)
  • Allergic or anaphylactoid reactions
• PRECAUTIONS:
  • Monitor hemoglobin levels closely to avoid overshooting the target range
  • Use with caution in patients with uncontrolled hypertension or cardiovascular disorders
  • Ensure cold chain integrity from storage to administration
  • Consider risk-benefit in oncology settings, especially in non-curative chemotherapy
  • Contraindicated in patients with PRCA or known hypersensitivity to EPO formulations