Initer 5000IU/0.5ml Injection

✔️ Uses of Initer IV/SC Injection

• Anemia due to chronic kidney disease
• Anemia due to cancer chemotherapy

✔️ Common adverse reactions include:

• CKD patients: Hypertension, muscle spasms, pyrexia, dizziness, upper respiratory tract infections.
• HIV patients: Fever, cough, rash, injection site irritation.
• Cancer patients: Nausea, vomiting, myalgia, arthralgia, weight loss, hyperglycemia, headache, and thrombosis.
• Surgical patients: Nausea, vomiting, injection site pain, chills, and deep vein thrombosis.
• Premature infants: A decrease in serum ferritin levels is common.

✔️ Dosage of Initer (Recombinant Human Erythropoietin)

Adult Dosage

Chronic Kidney Disease (CKD)-Associated Anemia:

• Non-Dialysis Patients: 50-100 units/kg IV/SC, 3 times weekly initially.
  • Initiate when:
    • Hemoglobin <10 g/dL.
    • The rate of hemoglobin decline suggests a likely need for RBC transfusion.
    • The goal is to reduce RBC transfusion risks (alloimmunization).
  • Adjust dose if hemoglobin exceeds 10 g/dL.
• Dialysis Patients: 50-100 units/kg IV, 3 times weekly initially.
  • Start when hemoglobin <10 g/dL.
  • Adjust dose if hemoglobin approaches or exceeds 11 g/dL.

Zidovudine-Related Anemia:

• 100 units/kg IV/SC, 3 times weekly initially.

Chemotherapy-Related Anemia:

• 150 units/kg IV/SC, 3 times weekly initially.
• Alternatively, 40,000 units SC, once weekly, until chemotherapy completion.

Surgical Patients:

• 300 units/kg SC once daily for 15 consecutive days (10 days before surgery, day of surgery, 4 days post-surgery).
• Alternatively, 600 units/kg SC, administered as 4 doses (21, 14, and 7 days before surgery, and day of surgery).

Pediatric Dosage

Chronic Kidney Disease-Associated Anemia:

• >1 month: 50 units/kg IV/SC, 3 times weekly initially.
  • For dialysis patients, IV route is preferred.
  • Initiate when hemoglobin is <10 g/dL. Reduce or interrupt if hemoglobin exceeds 11 g/dL.

Prematurity-Related Anemia:

• 25-100 units/kg SC, 3 times weekly or 200-400 units/kg SC/IV, every 24-48 hours for 2-6 weeks.

Zidovudine-Related Anemia:

• 8 months-17 years: 50-400 units/kg SC/IV, 2-3 times weekly.

Chemotherapy-Related Anemia:

• 5-18 years: 600 units/kg IV, once weekly.
• Do not exceed 40,000 units.

✔️ Indication of Initer IV/SC Injection

Initer is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with the following conditions:

1. Chronic Kidney Disease (CKD) (in both dialysis and non-dialysis patients).
2. Zidovudine treatment in HIV-infected patients.
3. Myelosuppressive chemotherapy (for patients undergoing chemotherapy with at least two more months planned).
4. Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
5. Prevention of anemia of prematurity in infants with birth weight between 750-1500 gm and gestational age less than 34 weeks.

✔️ Key Points: Initer IV/SC Injection

• Iron Status: Ensure adequate iron levels before starting therapy and monitor during treatment.
• Dose Adjustments: Adjust based on hemoglobin levels, aiming to avoid rapid increases.
• Safety Considerations: Regular monitoring of hemoglobin and careful dose adjustments to minimize adverse effects like hypertension and thrombosis.

✔️ Overdose Effects of Initer IV/SC Injection

• Overdose may lead to high hemoglobin levels, requiring dose reduction or discontinuation, and possibly phlebotomy. Severe hypertension may occur with overdose.

✔️ Preparation and Administration: Initer IV/SC Injection

• Do not shake. Do not use Erythropoietin alfa that has been shaken or frozen.
• Protect the syringe from light.
• Parenteral drug products should be inspected visually for particulate matter and discoloration before administration. Do not use any syringe exhibiting particulate matter or discoloration.
• Discard unused portions of Erythropoietin alfa.

✔️ Interaction

Haematinics enhance efficiency. Increased dose of heparin in patients undergoing dialysis.

✔️ Contraindications:

• Uncontrolled hypertension.
• Serious allergic reactions to erythropoietin alfa.
• Patients who have developed Pure Red Cell Aplasia (PRCA) after previous erythropoietin therapy.

✔️ Pregnancy & Lactation

• Pregnancy: Limited human studies; animal studies show potential risks. Use only if benefits outweigh risks in chronic renal failure.
• Lactation: It is unknown if erythropoietin alfa is excreted in breast milk. Caution is advised in nursing women.

✔️ Precautions and Warnings for Erythropoietin Use

1. Conditions Requiring Caution:
   • Controlled Hypertension: Use with caution, as erythropoietin can exacerbate hypertension. Monitor blood pressure regularly.
   • Ischemic Vascular Disease: Patients with a history of ischemic heart disease or other vascular conditions should be closely monitored, as erythropoietin may increase the risk of thromboembolic events.
   • Seizure History: Use cautiously in patients with a history of seizures, as there may be a risk of triggering new seizures during therapy.
   • Suspected Allergy: Avoid use in patients with a known or suspected hypersensitivity to the product. Monitor for signs of allergic reactions during treatment.
2. Iron Status Evaluation:
   • Before initiating erythropoietin therapy, ensure adequate iron stores to support effective erythropoiesis.
   • Key Parameters:
     • Transferrin Saturation: Should be at least 20%.
     • Serum Ferritin: Should be at least 100 ng/mL.
   • Iron Supplementation:
     • Most patients will require oral or intravenous iron supplements to maintain or improve iron levels during therapy. Iron levels should be regularly monitored and adjusted as needed.

✔️ Storage Conditions

• Store between 2ºC to 8ºC. Do not freeze or shake.
• Store in the original package to protect from light.