• Anemia associated with chronic kidney disease (CKD).
• Chemotherapy-induced anemia in patients with nonmyeloid malignancies when there is ≥2 additional mo of planned chemotherapy.

Contraindicated in:

• Hypersensitivity
• Uncontrolled hypertension
• Patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy
• Patients receiving chemotherapy when anticipated outcome is cure
• Patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion
• Patients who require immediate correction of anemia when RBC transfusions can be used instead.

Use Cautiously in:

• Cardiovascular disease or stroke
• Underlying hematologic diseases, including hemolytic anemia, sickle-cell anemia, thalassemia, and porphyria (safety not established)
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Safety not established in breastfeeding.

CV: hypertension, hypotension, chest pain, DEEP VEIN THROMBOSIS (ESPECIALLY WITH HGB >11 G/DL), edema, HF, MI.

Derm: ERYTHEMA MULTIFORME, pruritus, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN).

GI: abdominal pain, diarrhea, nausea, vomiting, constipation.

Hemat: pure red cell aplasia.

MS: myalgia, arthralgia, back pain, limb pain.

Neuro: dizziness, fatigue, headache, SEIZURES, STROKE, weakness.

Resp: cough, dyspnea, bronchitis, PULMONARY EMBOLISM (ESPECIALLY WITH HGB >11 G/DL).

Misc: fever, ↑ MORTALITY AND ↑ TUMOR GROWTH (ESPECIALLY WITH HGB >11 G/DL), HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), sepsis.

Drug-Drug:

• None reported.

• Solution for injection (single-dose vials): 25 mcg/mL; 40 mcg/mL; 60 mcg/mL; 100 mcg/mL; 200 mcg/mL; 300 mcg/mL;
• Solution for injection (prefilled syringes): 10 mcg/0.4 mL; 25 mcg/0.42 mL; 40 mcg/0.4 mL; 60 mcg/0.3 mL; 100 mcg/0.5 mL; 150 mcg/0.3 mL; 200 mcg/0.4 mL; 300 mcg/0.6 mL; 500 mcg/1 mL;

Anemia due to Chronic Kidney Disease

(Do not initiate if Hgb ≥10 g/dL; should only consider initiating therapy in patients not on dialysis if rate of hemoglobin decline indicates likelihood of requiring a RBC transfusion and a goal is to reduce the risk of alloimmunization and/or RBC transfusion risks)

• IV, SC (Adults): Starting treatment with darbepoetin (no previous epoetin): 0.45 mcg/kg once weekly or 0.75 mcg/kg every 2 wk (for patients on dialysis); 0.45 mcg/kg every 4 wk (for patients not on dialysis); use lowest dose sufficient to ↓ the need for RBC transfusions (do not exceed Hgb of 10 g/dL [patients not on dialysis] or 11 g/dL [patients on dialysis]); if Hgb ↑ by >1 g/dL in 2 wk, ↓ dose by 25%; if Hgb ↑ by <1 g/dL after 4 wk of therapy (with adequate iron stores), ↑ dose by 25%; do not ↑ dose more frequently than every 4 wk. Conversion from epoetin to darbepoetin: weekly epoetin dose <2500 units = 6.25 mcg/wk darbepoetin; weekly epoetin dose 2500–4999 units = 12.5 mcg/wk darbepoetin; weekly epoetin dose 5000–10,999 units = 25 mcg/wk darbepoetin; weekly epoetin dose 11,000–17,999 units = 40 mcg/wk darbepoetin; weekly epoetin dose 18,000–33,999 units = 60 mcg/wk darbepoetin; weekly epoetin dose 34,000–89,999 units = 100 mcg/wk darbepoetin; weekly epoetin dose >90,000 units = 200 mcg/wk darbepoetin.
• IV, SC (Children): Starting treatment with darbepoetin (no previous epoetin): 0.45 mcg/kg once weekly (may also start with 0.75 mcg/kg every 2 wk in patients not on dialysis); use lowest dose sufficient to ↓ the need for RBC transfusions (do not exceed Hgb of 12 g/dL; if Hgb ↑ by >1.0 g/dL in 2 wk, ↓ dose by 25%; if Hgb ↑ by <1 g/dL after 4 wk of therapy (with adequate iron stores), ↑ dose by 25%; do not ↑ dose more frequently than every 4 wk.

Anemia due to Chemotherapy

(Use only for chemotherapy-related anemia and discontinue when chemotherapy course is completed; do not initiate if Hgb ≥10 g/dL.)

• SC (Adults): 2.25 mcg/kg weekly or 500 mcg every 3 wk; target Hgb should not exceed 12 g/dL. If Hgb ↑ by >1 g/dL in 2 wk or reaches a level needed to avoid RBC transfusions, ↓ dose by 40%; if Hgb ↑ by <1 g/dL after 6 wk of therapy, ↑ dose to 4.5 mcg/kg weekly.

Aranesp

• Stimulates erythropoiesis (production of RBCs).

• Maintains and may elevate RBC counts, decreasing the need for transfusions.

Therapeutic Classification: antianemics

Pharmacologic Classification: erythropoiesis stimulating agents (ESA)

Absorption: 30–50% following SUBQ administration; IV administration results in complete bioavailability.

Distribution: Confined to the intravascular space.

Metabolism/Excretion: Unknown.

Half-life: SUBQ: 49 hr; IV: 21 hr.

(↑ in RBCs)

• Instruct patient to read the Medication Guide prior to beginning therapy and with each Rx refill in case of changes. Inform patients of risks and benefits of darbepoetin.
  • Discuss ways of preventing self-injury in patients at risk for seizures. Driving and activities requiring continuous alertness should be avoided.
  • Advise patient to stop darbepoetin and notify health care professional immediately if severe skin reactions (skin rash with itching, blisters, skin sores, peeling, areas of skin coming off) or signs and symptoms of serious allergic reactions (rash, itching, shortness of breath, wheezing, dizziness and fainting due to drop in blood pressure, swelling around mouth or eyes, fast pulse, sweating) occur.
  • Inform patient that use of darbepoetin may result in shortened overall survival and/or ↓ time to tumor progression. May also cause MI or stroke. Advise patient to notify health care professional immediately if chest pain; trouble breathing or shortness of breath; pain in legs, with or without swelling; a cool or pale arm or leg; sudden confusion, trouble speaking, or trouble understanding others’ speech; sudden numbness or weakness in face, arm, or leg, especially on one side of body; sudden trouble seeing; sudden trouble walking, dizziness, loss of balance or coordination; loss of consciousness (fainting); or hemodialysis vascular access stops working.
  • Advise patient to notify health care professional of darbepoetin prior to surgery.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Anemia of CKD: Stress importance of compliance with dietary restrictions, medications, and dialysis. Foods high in iron and low in potassium include liver, pork, veal, beef, mustard and turnip greens, peas, eggs, broccoli, kale, blackberries, strawberries, apple juice, watermelon, oatmeal, and enriched bread. Darbepoetin will result in increased sense of well-being, but it does not cure underlying disease.
• Home Care Issues: Home dialysis patients determined to be able to safely and effectively administer darbepoetin should be taught proper dose, administration technique with syringe, auto-injector or IV use, and disposal of equipment. Information for Patients and Caregivers should be provided to patient along with medication.

dar-be-POH-e-tin

NDC Code^*

• 55513- Amgen Inc
  • 55513-002- ARANESP
    • 55513-002-04- 4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-002-04) > 1 mL in 1 VIAL, SINGLE-DOSE (55513-002-01)

• 55513- Amgen Inc
  • 55513-003- ARANESP
    • 55513-003-04- 4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-003-04) > 1 mL in 1 VIAL, SINGLE-DOSE (55513-003-01)

• 55513- Amgen Inc
  • 55513-004- ARANESP
    • 55513-004-04- 4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-004-04) > 1 mL in 1 VIAL, SINGLE-DOSE (55513-004-01)

• 55513- Amgen Inc
  • 55513-005- ARANESP
    • 55513-005-04- 4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-005-04) > 1 mL in 1 VIAL, SINGLE-DOSE (55513-005-01)

• 55513- Amgen Inc
  • 55513-006- ARANESP
    • 55513-006-01- 1 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-006-01) > 1 mL in 1 VIAL, SINGLE-DOSE

• 55513- Amgen Inc
  • 55513-021- ARANESP
    • 55513-021-04- 1 BLISTER PACK in 1 PACKAGE (55513-021-04) > 4 SYRINGE in 1 BLISTER PACK >.4 mL in 1 SYRINGE (55513-021-01)

• 55513- Amgen Inc
  • 55513-023- ARANESP
    • 55513-023-04- 1 BLISTER PACK in 1 PACKAGE (55513-023-04) > 4 SYRINGE in 1 BLISTER PACK >.3 mL in 1 SYRINGE (55513-023-01)

• 55513- Amgen Inc
  • 55513-025- ARANESP
    • 55513-025-04- 1 BLISTER PACK in 1 PACKAGE (55513-025-04) > 4 SYRINGE in 1 BLISTER PACK >.5 mL in 1 SYRINGE (55513-025-01)

• 55513- Amgen Inc
  • 55513-027- ARANESP
    • 55513-027-04- 1 BLISTER PACK in 1 PACKAGE (55513-027-04) > 4 SYRINGE in 1 BLISTER PACK >.3 mL in 1 SYRINGE (55513-027-01)

• 55513- Amgen Inc
  • 55513-028- ARANESP
    • 55513-028-01- 1 BLISTER PACK in 1 PACKAGE (55513-028-01) > 1 SYRINGE in 1 BLISTER PACK >.4 mL in 1 SYRINGE

• 55513- Amgen Inc
  • 55513-032- ARANESP
    • 55513-032-01- 1 BLISTER PACK in 1 PACKAGE (55513-032-01) > 1 SYRINGE in 1 BLISTER PACK > 1 mL in 1 SYRINGE

• 55513- Amgen Inc
  • 55513-057- ARANESP
    • 55513-057-04- 1 BLISTER PACK in 1 PACKAGE (55513-057-04) > 4 SYRINGE in 1 BLISTER PACK >.42 mL in 1 SYRINGE (55513-057-01)

• 55513- Amgen Inc
  • 55513-098- ARANESP
    • 55513-098-04- 1 BLISTER PACK in 1 PACKAGE (55513-098-04) > 4 SYRINGE in 1 BLISTER PACK >.4 mL in 1 SYRINGE (55513-098-01)

• 55513- Amgen Inc
  • 55513-110- ARANESP
    • 55513-110-01- 1 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-110-01) > 1 mL in 1 VIAL, SINGLE-DOSE

• 55513- Amgen Inc
  • 55513-111- ARANESP
    • 55513-111-01- 1 BLISTER PACK in 1 PACKAGE (55513-111-01) > 1 SYRINGE in 1 BLISTER PACK >.6 mL in 1 SYRINGE