Epoetin delta

Summary

Epoetin delta is a recombinant human erythropoietin produced in human fibrosarcoma (HT-1080) cells, distinguishing it from other epoetins produced in CHO cells. It was approved in the EU under the brand name Dynepo for treatment of anemia in patients with chronic renal failure. It was subsequently withdrawn from the market for commercial reasons, not due to safety concerns.

Mechanism of Action

Binds to erythropoietin receptors on erythroid progenitor cells in bone marrow, stimulating proliferation, differentiation, and survival of red blood cell precursors, thereby increasing red blood cell production and correcting anemia.

Routes of Administration

Goals & Uses

• Anemia in cancer chemotherapy patientsOncology/HematologyLow
• Reduction of allogeneic blood transfusionsPerioperative MedicineModerate
• Treatment of anemia in chronic renal failureHematology/NephrologyHigh

Contraindications

• Hypersensitivity to epoetin delta or excipientsImmunologicalHigh
• Uncontrolled hypertensionCardiovascularHigh
• Hemoglobin ≥12 g/dL in cancer patientsOncologyModerate
• Pure red cell aplasia (PRCA) due to prior ESA therapyImmunologicalHigh

Adverse Effects

• Flu-like symptomsSystemic/ImmunologicalCommon
• HypertensionCardiovascularCommonHigh blood pressure
• Injection site reactionsLocalCommon
• HeadacheNeurologicCommonPain in the head or upper neck
• Pure red cell aplasia (PRCA)Immunological / HematologicalRare
• Thrombotic/thromboembolic eventsCardiovascular / HematologicalUncommon

Drug Interactions

• Antihypertensive agentsModerate
• CyclosporineModerate
• Iron supplementsLow

Population Constraints

• PregnancyReproductive SafetyRelative
• Cancer patients receiving curative-intent chemotherapyOncologyRelative
• Pediatric patientsAgeRelative
• Patients with cardiovascular diseaseComorbidityRelative

Regulatory Status

• European UnionWithdrawnApproved: Anemia associated with chronic renal failure in adult patientsApproved by EMA in 2002 (Dynepo); voluntarily withdrawn from market in 2008 by Shire for commercial/business reasons, not safety.
• United StatesUnapprovedNever received FDA approval; not marketed in the United States.
• United KingdomWithdrawnApproved: Anemia in chronic renal failureWas available as part of EU approval; no longer marketed following 2008 withdrawal.

Approved by the EMA in 2002 (Dynepo); voluntarily withdrawn from the EU market in 2008 by Shire for commercial reasons. Never approved in the US by the FDA.

Evidence & Sources

No sources recorded yet.