darbepoetin Indications Anemia associated with chronic renal failure. Chemotherapy-induced anemia in patients with non-myeloid malignancies.

Action Stimulates erythropoiesis (production of red blood cells). Therapeutic Effects: Maintains and may elevate red blood cell counts, decreasing the need for transfusions. Pharmacokinetics Absorption: 3050% following subcut administration; IV administration results in complete bioavailability. Distribution: Confined to the intravascular space. Metabolism and Excretion: Unknown. Half-life: Subcut49 hr; IV21 hr. TIME/ACTION PROFILE (increase in RBCs)
ROUTE ONSET PEAK DURATION IV, subcut 26 wk unknown unknown

Contraindications/Precautions Contraindicated in: Hypersensitivity; Uncontrolled hypertension; Patients receiving chemotherapy when anticipated outcome is cure. Use Cautiously in: History of hypertension; Underlying hematologic diseases, including hemolytic anemia, sickle-cell anemia, thalassemia and porphyria (safety not established); OB, Lactation, Pedi: Safety not established. Adverse Reactions/Side Effects CNS: SEIZURES, dizziness, fatigue, headache, weakness. Resp: cough, dyspnea, bronchitis. CV: CHF, MI, STROKE, THROMBOTIC EVENTS (especially with hemoglobin _12 g/dL), edema, hypertension, hypotension, chest pain. GI: abdominal pain, nausea, diarrhea, vomiting, constipation. Derm: pruritus. Hemat: pure red cell aplasia. MS: myalgia, arthralgia, back pain, limb pain. Misc: fever, allergic reactions, flu-like syndrome, sepsis,qmortality andqtumor growth (with hemoglobin _12 g/dL). Interactions Drug-Drug: None reported. Route/Dosage Anemia due to Chronic Renal Failure (Use lowest dose that will gradually increase hemoglobin level and avoid RBC transfusion). IV, Subcut (Adults): Starting treatment with darbepoetin (no previous epoetin)0.45 mcg/kg once weekly (may start with 0.75 mcg/kg q 2 wk in patients not on dialysis); adjust dose to attain target Hgb of 1012 g/dL; if Hgbqby _1.0 g/dL in 2 wk or if the Hgb isqand nearing 12 g/dL,pdose by 25%; if Hgbqby _1.0 g/dL after 4 wk of therapy (with adequate iron stores), qdose by 25%; do notqdose more frequently than q 4 wk. Conversion from epoetin to darbepoetin weekly epoetin dose _2500 units_ 6.25 mcg/week darbepoetin, weekly epoetin dose 25004999 units_12.5 mcg/week darbepoetin, weekly epoetin dose 500010,999 units_ 25 mcg/week darbepoetin, weekly epoetin dose 11,00017,999 units_40 mcg/week darbepoetin,

weekly epoetin dose 18,00033,999 units_ 60 mcg/week darbepoetin, weekly epoetin dose 34,00089,999 units_100 mcg/week darbepoetin, weekly epoetin dose _90,000 units_ 200 mcg/week darbepoetin. Anemia due to Chemotherapy (Use only for chemotherapy-related anemia and discontinue when chemotherapy course is completed; do not initiate if hemoglobin _10 g/dL.) Subcut (Adults): 2.25 mcg/kg weekly or 500 mcg q 3 wk; target Hgb should not exceed 12 g/ dL. If Hgbqby _1.0 g/dL in 2 wk or if the Hgb _12 g/dL or Hgb reaches level to avoid transfusion, pdose by 40%; if Hgbqby _1.0 g/dL after 6 wk of therapy,qdose to 4.5 mcg/kg . Availability Albumin solution for injection: 25 mcg/mL 1mL vial, 40 mcg/mL 1-mL vial, 60 mcg/mL 1-mL vial, 100 mcg/mL 1-mL vial, 150 mcg/mL 0.75-mL vial, 200 mcg/mL 1-mL vial, 300 mcg/mL 1-mL vial, 500 mcg/mL 1-mL vial. Pre-filled syringes: 60 mcg/0.3 mL, 100 mcg/0.5 mL, 200 mcg/0.4