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darbepoetin alfa

(dar bah poe e' tin)


Aranesp

Pregnancy Category C

Drug class
Erythropoiesis-stimulating protein

Therapeutic actions
An erythropoetin-like protein produced in Chinese hamster ovary cells by recombinant
DNA technology; stimulates red blood cell production in the bone marrow in the same
manner as naturally occurring erythropoetin, a hormone released into the bloodstream in
response to renal hypoxia.

Indications
• Treatment of anemia associated with chronic renal failure, including during
dialysis
• Treatment of chemotherapy-induced anemia in patients with nonmyeloid
malignancies

Contraindications and cautions


• Contraindicated with uncontrolled hypertension or hypersensitivity to any
component of the drug.
• Use cautiously with hypertension, pregnancy, lactation.

Available forms
Polysorbate solution for injection—25, 40, 60, 100, 200 mcg/mL

Dosages
ADULTS
• Starting dose: 0.45 mcg/kg IV or SC once per wk. Dosage may be adjusted no
more frequently than once per mo. Target hemoglobin level is 12 g/dL. Adjust
dosage by 25% at a time to achieve that level. Avoid rapid increase in
hemoglobin.
• Switching from epoetin alfa:
Epoetin alfa dose in units/wk Darbepoetin alfa dose in mcg/wk
< 2,500 6.25
2,500–4,999 12.5
5,000–10,999 25
11,000–17,999 40
18,000–33,999 60
34,000–89,999 100
≥ 90,000 200
Patients who were receiving epoetin 2 to 3 times per week should receive darbepoetin
once per wk. Patients who were receiving epoetin once per wk should receive
darbepoetin once every 2 wk.
• Chemotherapy-induced anemia: 2.25 mg/kg SC once per wk; adjust to maintain
acceptable hemoglobin levels.
PEDIATRIC PATIENTS
Safety and efficacy not established.

Pharmacokinetics
Route Peak Duration
SC 34 hr 24–72 hr
IV 1.4 hr 24–72 hr

Metabolism: Serum; T1/2: 21 hr (IV), 49 hr (SC)


Distribution: Crosses placenta; enters breast milk
Excretion: Urine

IV facts
Preparation: Administer as provided, no additional preparation needed. Enter vial only
once, discard any unused solution. Refrigerate. Do not shake vial. Inspect for any
discoloring or precipitates before use.
Infusion: Administer by direct IV injection or into tubing of running IV.
Incompatibilities: Do not mix with any other drug solution.

Adverse effects
• CNS: Headache, fatigue, asthenia, dizziness, seizure, TIA
• CV: Hypertension, edema, chest pain, arrhythmias, chest pain, MI, stroke, CVA
• GI: Nausea, vomiting, diarrha, abdominal pain
• Respiratory: Upper respiratory infection, dyspnea, cough
• Other: Arthralgias, myalgias, limb pain, clotting of access line, pain at injection
site

Nursing considerations
Assessment
• History: Hypertension; hypersensitivity to any component of product, pregnancy,
lactation
• Physical: Reflexes, affect, BP, P, R, adventitious sounds, urinary output, renal
function, renal function tests, CBC, Hct, iron levels, electrolytes

Interventions
• Ensure chronic, renal nature of anemia. Darbepoetin is not intended as a treatment
of severe anemia and is not a substitute for emergency transfusion.
• Prepare solution by gently mixing. Do not shake, shaking may denature the
glycoprotein. Use only one dose per vial; do not reenter the vial. Discard unused
portions.
• Do not administer with any other drug solution.
• Administer dose once weekly. If administered independent of dialysis, administer
into venous access line. If patient is not on dialysis, administer IV or SC.
• Monitor access lines for signs of clotting.
• Arrange for Hct reading before administration of each dose to determine
appropriate dosage. If patient fails to respond within 4 wk of therapy, evaluate
patient for other causes of the problem.
• Evaluate iron stores before and periodically during therapy. Supplemental iron
may be needed.
• Monitor diet and assess nutrition; arrange for nutritional consult as necessary.
• Establish safety precautions (eg side rails, environmental control, lighting) if CNS
effects occur.
• Maintain seizure precautions on standby during administration.
• Provide additional comfort measures, as necessary, to alleviate discomfort from
GI effects, headache.
• Offer support and encouragement to deal with chronic disease and need for
prolonged therapy and testing.

Teaching points
• The drug will need to be given once a week and can only be given IV or SC or
into a dialysis access line. Prepare a schedule of administration dates.
• Keep appointments for blood tests; frequent blood tests will be needed to
determine the effects of the drug on your blood count and to determine the
appropriate dosage needed.
• Maintain all of the usual activities and restrictions that apply to your chronic renal
failure. If this becomes difficult, consult with your health care provider.
• These side effects may occur: Dizziness, headache (avoid driving a car or
performing hazardous tasks); headache, fatigue, joint pain (consult with your
health care provider if these become bothersome; medications may be available to
help); nausea, vomiting, diarrhea (proper nutrition is important; consult with your
dietitian to maintain nutrition and ensure ready access to bathroom facilities);
upper respiratory infection, cough (consult with your health care provider if this
occurs).
• Report difficulty breathing, numbness or tingling, chest pain, seizures, severe
headache.

Adverse effects in Italic are most common; those in Bold are life-threatening.