1. Definition & Composition
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Generic Name: Darbepoetin Alfa
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Strength: 60 mcg per dose (single-use vial/prefilled syringe)
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Class: Long-acting Erythropoiesis-Stimulating Agent (ESA)
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Composition:
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Active: Darbepoetin Alfa (recombinant glycoprotein)
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Excipients: Sodium phosphate, polysorbate 80, sucrose (stabilizers)
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2. Importance
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Treats anemia in:
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Chronic Kidney Disease (CKD) (dialysis/non-dialysis)
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Chemotherapy-induced anemia (non-myeloid cancers)
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Reduces transfusion dependency
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Longer half-life than EPO → Less frequent dosing (weekly/biweekly)
3. Uses (Indications)
✅ Approved:
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CKD-related anemia (Hb <10 g/dL)
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Cancer patients on chemotherapy (Hb <10 g/dL)
🚫 Not for: -
Anemia due to iron/B12/folate deficiency (correct deficiencies first).
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Anemia in myeloid cancers (e.g., AML, CML).
4. Dosage & Administration
Patient Group | Route | Initial Dose | Maintenance |
---|---|---|---|
CKD (Dialysis) | IV/SC | 0.45 mcg/kg weekly | Adjust to Hb 10–12 g/dL |
CKD (Non-Dialysis) | SC | 0.45 mcg/kg every 2–4 weeks | Monitor Hb monthly |
Chemotherapy Anemia | SC | 2.25 mcg/kg weekly or 500 mcg every 3 weeks | Hold if Hb >12 g/dL |
⚠️ Critical Notes:
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Target Hb: 10–12 g/dL (Never >12 g/dL → ↑ thrombosis risk).
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Iron Supplementation: Required if ferritin <100 ng/mL.
5. Side Effects
Common (≥10%):
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Hypertension (↑ BP)
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Headache, dizziness
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Injection-site reactions (pain, swelling)
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Nausea, diarrhea
Serious (Monitor Closely):
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Thrombosis (DVT, stroke, MI) – *Major risk if Hb >12 g/dL*
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Pure Red Cell Aplasia (PRCA) – Rare antibody-mediated RBC failure
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Seizures (in CKD patients)
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Severe allergic reactions (rash, angioedema)
6. Storage & Handling
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Temperature: Refrigerate at 2–8°C (Do not freeze).
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Light Protection: Keep in original carton.
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Shaking: Avoid – causes protein denaturation.
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Expiry: Discard unused portions (single-dose vial).
7. Contraindications & Warnings
❌ Avoid in:
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Uncontrolled hypertension
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PRCA post-ESA therapy
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Hypersensitivity to darbepoetin
⚠️ FDA Black Box Warning:
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↑ Risk of death, thrombosis, and tumor progression (in cancer patients).
8. Conclusion
CRESP 60 (Darbepoetin Alfa 60 mcg) is a high-dose ESA for severe anemia in CKD and chemotherapy patients. While effective, it demands:
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Strict Hb monitoring (10–12 g/dL).
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Iron status checks (ferritin, TSAT).
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Specialist supervision to mitigate risks (thrombosis, PRCA).
For Best Outcomes:
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Use the lowest effective dose.
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Combine with iron therapy if deficient.
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Avoid in curable cancers (may worsen survival).
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