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Safety Information

Darbepoetin alfa is to be prescribed by a Registered Medical Practitioner only. Consult your local Registered Medical Practitioner before any usage.

Indications and Usage
  • Treatment of symptomatic anemia associated with chronic renal failure (CRF) in adults and pediatric patients, including patients on dialysis and patients not on dialysis.
  • Treatment of symptomatic anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
  • Hypersensitivity to darbepoetin alfa, recombinant human erythropoietin (rHuEPO) or any of the excipients.
  • Poorly controlled hypertension.
Appropriate Usage
Response to treatment with darbepoetin depends on effective monitoring of general body parameters and identifying all potential causes necessitating the need for treatment with erythropoiesis stimulating agents (ESAs), evaluating these before initiation of treatment, during and after. In case of any allergic reactions or abnormal laboratory parameters or symptoms in a patient, the treating clinician should be consulted for timely intervention and appropriate management. Identifying and alleviating the root cause would be crucial to obtaining a good response to treatment. Possibilities of drug-drug interaction including alternative medicine should also be ruled out as these patients generally would be on multi-drug regimen. Caution should be exercised when prescribing to pregnant women or lactating mothers.

Post-Marketing Experience with Darbepoetin Alfa
The following adverse reactions have been identified during postmarketing use of darbepoetin alfa:
  • Pure Red Cell Aplasia. In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with darbepoetin alfa therapies have been reported predominantly in patients with CRF treated subcutaneously. In case PRCA is diagnosed, therapy with darbepoetin alfa must be discontinued and patients should not be switched to another recombinant erythropoietic protein.
  • Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria.
  • Convulsions
The therapeutic margin of darbepoetin alfa is very wide. Even at very high serum levels, no symptoms of overdose have been observed. In the event of polycythemia, darbepoetin alfa should be temporarily withheld. If clinically indicated, phlebotomy may be performed.

In the absence of incompatibility studies, darbepoetin alfa should not be mixed or administered as an infusion with other medicinal products.

For more information, please see full Prescribing Information for CRESP®.
For a full list of reported side effects please see the Prescribing Information.

CRF = chronic renal failure, ESAs = erythropoiesis stimulating agents, PRCA = pure red cell aplasia, rHuEPO = recombinant human erythropoietin

1. Cresp® (Darbepoetin alfa) Prescribing Information, Dr. Reddy's.