darbepoetin alfa

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darbepoetin alfa


FDA Box Warning

In patients with chronic kidney disease, drug increases risk of death, serious cardiovascular events, and stroke when given to target hemoglobin level above 11 g/dl.

No trial has identified a hemoglobin target level, darbepoetin alfa dosage, or dosing strategy that doesn't increase these risks.

Use lowest dose sufficient to reduce need for red blood cell (RBC) transfusions.

Drug may shorten overall survival or increase risk of tumor progression or recurrence in patients with breast, non-small-cell lung, head and neck, lymphoid, and cervical cancers.

Prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe or dispense this drug to patients with cancer.

Use drug only for treatment of anemia due to myelosuppressive chemotherapy.

Drug isn't indicated for patients receiving myelosuppressants when the anticipated outcome is cure.

Discontinue drug following completion of a chemotherapy course.


Stimulates erythropoiesis in bone marrow, increasing red blood cell production


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.


• Serious allergic reactions to drug

• Uncontrolled hypertension

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


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.


• 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


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.

darbepoetin alfa

a hematopoietic agent used to treat anemia associated with chronic renal failure or anemia in nonmyeloid malignancies.
References in periodicals archive ?
In addition, Amgen currently owns the patent Aranesp for Darbepoetin alfa; which is expected to expire by 2016, thus, calling for launch of Darbepoetin Alfa biosimilars.
Darbepoetin alfa (Aranesp *) dosing is not different between the IV and subcutaneous routes of administration, hence, both KDIGO (2012) and CSN (Moist et al.
Darbepoetin alfa is a synthetic form of erythropoietin, clinically proven to stimulate erythropoiesis (increased hemoglobin levels) for patients with anemia due to chronic kidney disease.
There has also been a shift toward less frequent administration due to the introduction of darbepoetin alfa during this period (Theodoridis et al.
At least one more darbepoetin alfa biosimilar is expected to hit market this year from Avesthagen, a notable biotech firm from India's biotech hub of Bangalore.
The company said that darbepoetin alfa will be sold under the brand name Cresp in India.
Clinical trials have shown that sc administration of epoetin beta is less painful than sc administration of either epoetin alfa or darbepoetin alfa (Frenken et al.
Amgen manufactures the three ESAs currently marketed in the United States, two epoetin alfa products (Procrit and Epogen) and darbepoetin alfa (Aranesp).
Steven Elliott, who led the Amgen team that created the endurance-boosting drug NESP (also known as darbepoetin alfa and Aranesp), was shocked at the results of drug tests taken from athletes at the 2002 Winter Olympics.
MIRCERA is the only drug to have compared itself in its registration program to three ESAs: epoetin alfa, beta and darbepoetin alfa.
The company provided updates on recent meetings of the Independent Data Monitoring Committees for both TREAT (Trial to Reduce cardiovascular Events with Aranesp Therapy), which examines outcomes in anemic patients with renal insufficiency, and the RED-HF (Reduction of Events with Darbepoetin alfa in Heart Failure) TrialTM, which examines the utility of Aranesp for the treatment of heart failure.
Tokyo, Japan, Apr 25, 2007 - (JCN) - Kirin Brewery announced that it received manufacturing and marketing approval for its long-acting erythropoiesis stimulating agent Darbepoetin Alfa, brand name NESP(R) Injection Syringe, on April 18, 2007.