Recogen 10000

Indications

Recogen is an erythropoiesis-stimulating agent (ESA) designed to treat and manage:

• Anemia associated with:
  • Chronic Kidney Disease (CKD) in both dialysis and non-dialysis patients.
  • Zidovudine therapy in HIV-infected individuals.
  • Myelosuppressive chemotherapy when at least two additional months of chemotherapy are planned.
• Reduction of allogeneic RBC transfusions for patients undergoing elective, non-cardiac, non-vascular surgeries.
• Prevention of anemia in premature infants with birth weights between 750–1500 grams and gestational ages under 34 weeks.

Always use as directed by a registered physician.

Description

Recogen is a recombinant human erythropoietin (EPO) produced using Chinese hamster ovary cells. Its amino acid sequence is identical to naturally occurring human urinary EPO, with a molecular weight of approximately 30,400 daltons.

Dosage Guidelines

Assessment Before Treatment

Evaluate iron levels, nutritional status, and potential causes of anemia (e.g., vitamin deficiencies, metabolic disorders, or bleeding). Ensure iron stores are adequate before initiating Recogen therapy.

For CKD Patients

1. General Recommendations:
   • Monitor hemoglobin weekly until stable, then at least monthly.
   • Adjust dosage based on hemoglobin trends and ESA responsiveness.
   • Avoid increasing doses more frequently than every 4 weeks. Reduce doses promptly if hemoglobin rises rapidly (e.g., >1 g/dL in 2 weeks).
2. For Dialysis Patients:
   • Start when hemoglobin levels are <10 g/dL.
   • Adjust or interrupt the dose if hemoglobin levels approach or exceed 11 g/dL.
   • Adult Dose: 50–100 units/kg, administered intravenously or subcutaneously three times weekly.
   • Pediatric Dose: 50 units/kg, administered similarly.
3. For Non-Dialysis Patients:
   • Begin treatment when hemoglobin levels are <10 g/dL, considering transfusion risks and patient needs.
   • Adult Dose: 50–100 units/kg, administered intravenously or subcutaneously three times weekly.

Other Specific Dosages

• HIV Patients on Zidovudine: Start with 100 units/kg (IV or SC) three times weekly.
• Cancer Patients on Chemotherapy:
  • Adults: 150 units/kg SC three times per week or 40,000 units SC weekly.
  • Children (5–18 years): 600 units/kg IV weekly.
• Prevention of Anemia in Premature Infants: Administer 250 IU/kg SC thrice weekly for 6 weeks. Begin treatment by day 3 of life for maximum benefit.

Always follow your physician’s instructions for dosage adjustments.

Administration Instructions

• Do not shake or freeze. Discard any discolored syringes or those with particulates.
• Protect syringes from light.
• Inspect the product visually before administration.

Administer as prescribed by a healthcare professional.

Interactions

While no major drug interactions have been reported, simultaneous use with iron supplements like ferrous sulfate can enhance the effects of Recogen in iron-deficient states.

Contraindications

Do not use Recogen in:

• Patients with uncontrolled hypertension.
• Those with severe allergic reactions to erythropoietin alfa.
• Patients who have developed Pure Red Cell Aplasia (PRCA) after ESA treatment.

Possible Side Effects

1. CKD Patients: Hypertension, muscle spasms, fever, dizziness, and vascular complications.
2. HIV Patients on Zidovudine: Fever, rash, cough, and injection site irritation.
3. Cancer Chemotherapy Patients: Nausea, vomiting, joint pain, rash, and thrombosis.
4. Surgical Patients: Headaches, deep vein thrombosis, nausea, and pruritus.
5. Premature Infants: Commonly experience decreased serum ferritin levels.

Pregnancy and Breastfeeding

• Use during pregnancy only if the benefits outweigh the risks, especially in chronic renal failure patients.
• It is unknown if erythropoietin alfa is excreted in breast milk. Breastfeeding mothers should consult their doctor to weigh the risks and benefits.

Overdose Management

Overdosing may elevate hemoglobin levels excessively, potentially requiring dose adjustments or phlebotomy. Severe hypertension may occur.

Storage Instructions

• Store at 2°C to 8°C. Avoid freezing or shaking.
• Keep in the original packaging to protect from light.

Therapeutic Class

Recogen belongs to the class of medications used for hemolytic, hypoplastic, and renal anemia treatments.