Action

Stimulates erythropoiesis in bone marrow, increasing red blood cell production

Availability

Solution for injection: 25 mcg/ml, 40 mcg/ml, 60 mcg/ml, 100 mcg/ml, 200 mcg/ml, 300 mcg/ml, 500 mcg/ml, 150 mcg/0.75 ml in single-dose vials; 25 mcg/0.42ml, 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 in single-dose prefilled syringes

Indications and dosages

➣ Anemia caused by chronic kidney disease (CKD) in patients on dialysis

Adults: Initially, 0.45 mcg/kg I.V. or subcutaneously weekly, or 0.75 mcg/kg I.V. or subcutaneously q 2 weeks

➣ Anemia caused by CKD in patients not on dialysis

Adults: 0.45 mcg/kg I.V. or subcutaneously at 4-week intervals

➣ Chemotherapy-induced anemia in patients with nonmyeloid malignancies

Adults: 2.25 mcg/kg subcutaneously q week, or 500 mcg subcutaneously q 3 weeks.

Contraindications

• Serious allergic reactions to drug

• Uncontrolled hypertension

• Pure red cell aplasia that begins after treatment with darbepoetin alfa or other erythropoietin protein drugs

Precautions

Use cautiously in:

• latex allergy (needle cover of prefilled syringe contains dry natural rubber, a derivative of latex)

• anemia; thalassemia; porphyria; seizures; underlying hematologic disease, including hemolytic and sickle cell anemia

• lack or loss of response to drug

• pregnant or breastfeeding patients

• children.

Administration

• Give by subcutaneous or I.V. injection only. (I.V. route is recommended for patients on hemodialysis.)

• Evaluate iron status for all patients before and during treatment to ensure effective erythropoiesis.

• For patients with CKD on dialysis, start drug when hemoglobin level is less than 10 g/dl. If hemoglobin level approaches or exceeds 11 g/dl, reduce dosage or interrupt therapy.

• For patients with CKD not on dialysis, consider starting drug only when hemoglobin level is less than 10 g/dl and the following considerations apply: Rate of hemoglobin decline indicates likelihood of requiring an RBC transfusion and, reducing risk of alloimmunization or other RBC transfusion-related risks is a goal. If hemoglobin level exceeds 10 g/dl, reduce dosage or interrupt therapy and use lowest dose sufficient to reduce need for RBC transfusions.

• Don't increase dosage more frequently than once q 4 weeks; dosage decreases can occur more frequently. Avoid frequent dosage adjustments.

• Don't dilute or give with other drug solutions.

Don't shake. Vigorous shaking may denature drug, making it biologically inactive.

• Give single I.V. dose over 1 minute.

• Discard unused portion. (Drug contains no preservative.)

Adverse reactions

CNS: dizziness, headache, fatigue, weakness, seizures, transient ischemic attack, cerebrovascular accident

CV: hypertension, hypotension, chest pain, peripheral edema, arrhythmias, heart failure, cardiac arrest, myocardial infarction, vascular access thrombosis

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

Metabolic: fluid overload

Musculoskeletal: myalgia; joint, back, and limb pain

Respiratory: cough, upper respiratory tract infection, dyspnea, bronchitis

Skin: pruritus

Other: fever, flulike symptoms, infection, pain at injection site

Interactions

None significant

Patient monitoring

• Assess hemoglobin concentration before starting therapy and then weekly during therapy.

• Observe closely for serious CNS and cardiovascular adverse reactions.

• Closely monitor blood pressure and renal function during therapy.

• Know that supplemental iron is recommended for patients with serum ferritin level below 100 mcg/ml or serum transferrin saturation below 20%.

Patient teaching

• Tell patient to report chest pain or other pain, muscle tremors, weakness, and cough or other respiratory symptoms.

• If patient will self-administer drug, tell him to follow exact directions for injection and needle disposal.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• Advise patient to minimize GI upset by eating small, frequent servings of healthy food and drinking plenty of fluids.

• Tell patient he'll undergo frequent blood testing during therapy to help determine correct dosage.

• As appropriate, review all other significant and life-threatening adverse reactions.