Initer 3000 IU Pre-filled Injection

Uses of Initer 3000 IU Pre-filled Injection

Anemia due to chronic kidney disease, cancer chemotherapy, and zidovudine-related anemia in HIV-infected patients.

How does Initer 3000 IU Pre-filled Injection work?

It works by stimulating the bone marrow to produce more red blood cells.

Side Effects of Initer 3000 IU Pre-filled Injection

Adverse reactions vary depending on the indication but may include hypertension, arthralgia, muscle spasms, pyrexia, cough, rash, vomiting, myalgia, and more.

Quick Suggestions:

• Initer 3000 is given as a single injection under the skin.
• Regular blood tests and blood pressure monitoring are essential during treatment.

Pharmacology

• Recombinant human erythropoietin (EPO) with a 165 amino acid sequence identical to human urinary EPO.
• Adjustments are based on hemoglobin levels, patient response, and other factors. Evaluate iron stores before and during treatment. Monitor patients regularly and consider dose adjustments accordingly.

Dosage Guidelines for Initer (Erythropoietin alfa) in Different Conditions:

Evaluation of Iron Stores and Nutritional Factors:

• Assess iron status before and during treatment.
• Correct or exclude other causes of anemia.
• Monitor regularly to maintain iron repletion.

Chronic Kidney Disease (CKD):

• Monitor hemoglobin levels weekly initially, then at least monthly.
• Adjust therapy based on hemoglobin rate of rise, decline, ESA responsiveness, and variability.
• Avoid frequent dose adjustments.
• Reduce dose by 25% or more if hemoglobin rises rapidly (>1 g/dL in any 2 weeks).
• Increase dose by 25% if hemoglobin has not increased by more than 1 g/dL after 4 weeks.
• Discontinue if responsiveness does not improve after a 12-week escalation period.
• Dialysis Patients:
  • Initiate treatment when hemoglobin <10 g/dL.
  • Reduce or interrupt the dose if hemoglobin approaches or exceeds 11 g/dL.
  • Starting dose: 50 to 100 units/kg 3 times weekly intravenously or subcutaneously.
• Non-Dialysis Patients:
  • Consider initiation when hemoglobin <10 g/dL and risk factors for RBC transfusion exist.
  • Reduce or interrupt the dose if hemoglobin exceeds 10 g/dL.
  • Starting dose: 50 to 100 units/kg 3 times weekly intravenously or subcutaneously.

Zidovudine-treated HIV-infected Patients:

• Starting dose: 100 units/kg 3 times per week intravenously or subcutaneously.
• Adjust the dose if hemoglobin does not increase after 8 weeks of therapy.
• Withhold if hemoglobin exceeds 12 g/dL and resume at a lower dose when it falls below 11 g/dL.
• Discontinue if an increase in hemoglobin is not achieved at a dose of 300 units/kg for 8 weeks.

Patients on Cancer Chemotherapy:

• Initiate if hemoglobin <10 g/dL and with planned chemotherapy for at least two months.
• Adults: 150 units/kg subcutaneously 3 times per week or 40,000 units subcutaneously weekly until completion of chemotherapy.
• Pediatric Patients (5 to 18 years): 600 units/kg intravenously weekly until completion of chemotherapy.

Prevention of Anemia of Prematurity:

• Administer subcutaneously at a dose of 3x250 IU/kg b.w. per week.
• Start as early as possible, preferably by day 3 of life, and continue for 6 weeks.

Administration & Overdose Effects

• Preparation and Administration: Do not shake or freeze. Protect from light. Inspect visually before administration. Discard unused portions.
• Interaction: No known clinically significant drug interactions, but concurrent use with haematinic agents like ferrous sulfate may potentiate its effect.

Overdose Effects: Manage with discontinuation or reduction of dosage and/or phlebotomy if hemoglobin levels exceed desired levels. Severe hypertension may occur.

Interaction

Haematinics can enhance its efficacy, and increased heparin doses may be required in patients undergoing dialysis.

Contraindications

• Uncontrolled hypertension.
• Serious allergic reactions to Erythropoietin alfa.
• Patients with Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin.

Pregnancy & Lactation

Limited data are available. Use in pregnancy if benefits outweigh risks. Caution is advised during breastfeeding.

Precautions & Warnings

• Use erythropoietin with caution in patients with controlled hypertension.
• Monitor blood pressure regularly during therapy.
• Exercise caution when prescribing erythropoietin to patients with ischemic vascular disease.
• Assess the risk versus benefit of treatment in such patients.
• Patients with a history of seizures should use erythropoietin cautiously.
• Monitor closely for any exacerbation of seizure activity during treatment.
• Patients with a suspected allergy to erythropoietin should be monitored closely during therapy.
• Consider alternative treatment options if allergy symptoms occur.
• Assess iron stores, including transferrin saturation and serum ferritin, before and during erythropoietin therapy.
• Transferrin saturation should be maintained at least 20%, and ferritin levels should be at least 100 ng/mL.
• Most patients will require supplemental iron to achieve or maintain adequate transferrin saturation levels for erythropoiesis support.
• The excretion of erythropoietin in breast milk is unknown.
• Use caution when administering erythropoietin to lactating women.
• Avoid using multidose vials to minimize the risk of contamination or inadvertent exposure.

Storage Conditions:

Store at 2ºC to 8ºC, protect from freezing and light. Maintain temperature until administration. Store in the original package.