1. Definition & Composition
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Generic Name:Ā Darbepoetin Alfa
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Strength:Ā 60 mcg per dose (single-use vial/prefilled syringe)
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Class:Ā Long-actingĀ Erythropoiesis-Stimulating Agent (ESA)
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Composition:
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Active:Ā Darbepoetin AlfaĀ (recombinant glycoprotein)
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Excipients: Sodium phosphate, polysorbate 80, sucrose (stabilizers)
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2. Importance
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Treats anemiaĀ in:
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Chronic Kidney Disease (CKD)Ā (dialysis/non-dialysis)
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Chemotherapy-induced anemiaĀ (non-myeloid cancers)
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Reduces transfusion dependency
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Longer half-lifeĀ than EPO ā Less frequent dosing (weekly/biweekly)
3. Uses (Indications)
ā Ā Approved:
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CKD-related anemiaĀ (Hb <10 g/dL)
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Cancer patientsĀ on chemotherapy (Hb <10 g/dL)
š«Ā Not for: -
Anemia due to iron/B12/folate deficiency (correct deficiencies first).
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Anemia inĀ myeloid cancersĀ (e.g., AML, CML).
4. Dosage & Administration
Patient Group | Route | Initial Dose | Maintenance |
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CKD (Dialysis) | IV/SC | 0.45 mcg/kgĀ weekly | Adjust to Hb 10ā12 g/dL |
CKD (Non-Dialysis) | SC | 0.45 mcg/kgĀ every 2ā4 weeks | Monitor Hb monthly |
Chemotherapy Anemia | SC | 2.25 mcg/kgĀ weeklyĀ or 500 mcgĀ every 3 weeks | Hold if Hb >12 g/dL |
ā ļøĀ Critical Notes:
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Target Hb:Ā 10ā12 g/dL (Never >12 g/dL ā ā thrombosis risk).
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Iron Supplementation:Ā Required if ferritin <100 ng/mL.
5. Side Effects
Common (ā„10%):
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Hypertension (ā 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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ThrombosisĀ (DVT, stroke, MI) āĀ *Major risk if Hb >12 g/dL*
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Pure Red Cell Aplasia (PRCA)Ā ā Rare antibody-mediated RBC failure
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SeizuresĀ (in CKD patients)
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Severe allergic reactionsĀ (rash, angioedema)
6. Storage & Handling
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Temperature:Ā Refrigerate atĀ 2ā8°CĀ (Do not freeze).
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Light Protection:Ā Keep in original carton.
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Shaking:Ā Avoid ā causes protein denaturation.
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Expiry:Ā Discard unused portions (single-dose vial).
7. Contraindications & Warnings
āĀ Avoid in:
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Uncontrolled hypertension
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PRCA post-ESA therapy
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Hypersensitivity to darbepoetin
ā ļøĀ FDA Black Box Warning:
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ā Risk ofĀ death, thrombosis, and tumor progressionĀ (in cancer patients).
8. Conclusion
CRESP 60 (Darbepoetin Alfa 60 mcg)Ā is aĀ high-dose ESAĀ for severe anemia in CKD and chemotherapy patients. While effective, it demands:
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Strict Hb monitoringĀ (10ā12 g/dL).
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Iron status checksĀ (ferritin, TSAT).
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Specialist supervisionĀ to mitigate risks (thrombosis, PRCA).
For Best Outcomes:
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Use theĀ lowest effective dose.
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Combine withĀ iron therapyĀ if deficient.
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Avoid inĀ curable cancersĀ (may worsen survival).
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