Darbetin 100 mcg/0.5ml

Anemia Due To Chronic Kidney Disease: Darbepoetin Alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.

Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.

Usual Adult Dose for Anemia Associated with Chronic Renal Failure:

Chronic Kidney Disease (CKD) Patients Not on Dialysis:

• Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate
• Comments: Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.

CKD Patients on Dialysis:

• Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate
• Comments: Initiate treatment when hemoglobin is less than 10 g/dL. IV route is recommended for patients on hemodialysis.

Usual Adult Dose for Anemia Associated with Chemotherapy:

• Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks
• Duration of therapy: Until completion of chemotherapy course
• Comments: Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions.
• Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.

Antagonism of hypotensive effect and increased risk of hyperkalemia with ACE inhibitors and angiotensin II receptor antagonists. Ethanol.

Darbepoetin is contraindicated in patients with:

• Uncontrolled hypertension
• Pure red cell aplasia (PRCA) that begins after treatment with Darbepoetin or other erythropoietin protein drugs
• Serious allergic reactions to Darbepoetin

Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism; Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with cancer; Hypertension; Seizures; Serious allergic reaction; Severe Cutaneous Reactions

Pregnancy Category C. It is not known whether Darbepoetin Alfa is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Darbepoetin Alfa is administered to a nursing woman.