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Epofit 10000iu - Erythropoietin Injection

Epofit 10000 IU is a recombinant human erythropoietin injection used to treat anemia, particularly in patients with chronic kidney disease or undergoing chemotherapy. It stimulates red blood cell production by acting on the bone marrow.

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General Information:
Generic Name: Erythropoietin Alfa
Brand Name: Epofit
Packing: Pre-filled syringe or vial
Strength: 10000 IU per 1 ml
Manufacturer: Biocon
Form: Injectable solution
Category: Hematopoietic Agent / Anti-anemic
Product Intro:
Epofit 10000 IU is a hematopoietic agent containing Erythropoietin alfa, a synthetic version of the natural hormone erythropoietin. It is primarily used to manage anemia related to chronic kidney disease, cancer chemotherapy, and HIV therapy. It enhances the body's ability to produce red blood cells, thereby improving oxygen delivery to tissues.

Uses:
  1. Anemia due to Chronic Kidney Disease (CKD) – especially in patients on dialysis
  2. Chemotherapy-induced Anemia – in cancer patients receiving myelosuppressive treatment
  3. Anemia in HIV-infected patients – treated with zidovudine
  4. To reduce allogeneic blood transfusion – in elective, non-cardiac, non-vascular surgery
  5. Anemia due to bone marrow disorders – such as myelodysplastic syndromes
  6. Support in autologous blood donation programs

Storage Instructions:
  1. Store at 2°C to 8°C (refrigerator temperature)
  2. Do not freeze
  3. Protect from light
  4. Keep in original packaging
  5. Allow to reach room temperature before injection

How it Works (Mechanism of Action):
Erythropoietin alfa binds to erythropoietin receptors on erythroid progenitor cells in the bone marrow, stimulating them to proliferate and mature into red blood cells. This action helps restore hemoglobin levels and reduces the need for blood transfusions.

Side Effects:
Common Side Effects:
  1. Injection site pain or redness
  2. Headache
  3. Nausea
  4. Vomiting
  5. Fever
  6. Fatigue
Serious Side Effects:
  1. Hypertension (high blood pressure)
  2. Thromboembolic events (e.g., stroke, DVT)
  3. Pure Red Cell Aplasia (PRCA) – rare but serious immune-mediated condition
  4. Seizures
  5. Allergic reactions – including anaphylaxis

Dosage (Typical Recommended Dose):
  1. CKD (dialysis patients): 50–100 IU/kg, 3 times/week IV or SC
  2. Chemotherapy-induced anemia: 150 IU/kg SC 3 times/week or 40,000 IU SC once weekly
  3. Dosage is individualized based on patient’s hemoglobin level and response

Method of Administration:
  1. Administered subcutaneously (SC) or intravenously (IV)
  2. Given by a healthcare provider or under trained supervision
  3. Rotate injection sites if given subcutaneously
  4. Inspect for particles or discoloration before use

Precautions:
  1. Monitor hemoglobin levels regularly
  2. Do not exceed hemoglobin >12 g/dL – risk of cardiovascular complications
  3. Use cautiously in patients with hypertension or history of thrombosis
  4. Evaluate iron status; supplement if deficient
  5. Discontinue if signs of PRCA appear

Drug Interactions:
  1. No major drug-drug interactions, but monitor closely with:
    1. Immunosuppressive agents (may affect erythropoietin activity)
    2. Antihypertensives – may require dose adjustments
    3. Iron supplements – often given concurrently to enhance effectiveness

Allergies:
  1. Contraindicated in patients with known hypersensitivity to erythropoietin or albumin-containing products
  2. Signs of allergic reactions include:
    1. Rash, itching
    2. Swelling of face/lips
    3. Breathing difficulty
    4. Anaphylaxis (rare)

Overdose Information:
  1. Symptoms: Excessive increase in hemoglobin, hypertension, thrombotic events
  2. Management: Stop drug, provide symptomatic treatment
  3. Dialysis or phlebotomy may be required in extreme cases

Missed Dose Instructions:
  1. Administer the missed dose as soon as possible
  2. If close to the next dose, skip the missed dose – do not double
  3. Resume regular dosing schedule

Additional Notes:
  1. Ensure adequate iron, folate, and vitamin B12 levels during treatment
  2. Regularly monitor blood pressure and hematocrit
  3. Inform the doctor of any unusual tiredness, breathlessness, or dizziness
  4. Therapy may take 2–6 weeks for noticeable improvement in hemoglobin
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