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.