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.

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.

darbepoetin alfa

a hematopoietic agent used to treat anemia associated with chronic renal failure or anemia in nonmyeloid malignancies.
References in periodicals archive ?
Federal prosecutors in the United States District Court in Brooklyn say Amgen continued to promote the use of Aranesp to treat anemia in cancer patients who were not undergoing chemotherapy, even though the Food and Drug Administration had approved the drug only for use by patients receiving chemotherapy.
Recent changes in coverage rules and adjustments to Amgen's FDA approved labels for Epogen and Aranesp have and will adversely affect Amgen's revenue.
Worldwide sales of Aranesp (darbepoetin alfa) increased 14 percent to $1,020 million in the first quarter of 2007 versus $893 million during the first quarter of 2006.
That decrease was due partly to the popularity of Amgen's other anemia drug, Aranesp, and to inventory changes made by wholesalers, company officers said.
A 12-week head-to-head study of Aranesp compared to Procrit involving 122 patients led by John Glaspy, MD, MPH, University of California (Los Angeles, CA) was presented at the meeting.
Police raids on cycle teams at last year's Giro d'Italia race uncovered quantities of Aranesp - or nesp as it is known by illicit users.
Aranesp may provide both chemotherapy patients and caregivers the power to simplify anemia management," said Roger Perlmutter, Amgen's executive vice president for Research & Development.
Like epoietin alfa (Procrit and Epogen), Aranesp acts like endogenous erythropoietin, stimulating red blood cell production, but has a longer half-life and can be administered less frequently.
In 2006 Horwitz alerted authorities to Amgen's alleged manipulation of the scientific record regarding two of its blockbuster drugs, Aranesp and Neulasta.
Amgen's drugs Epogen and Aranesp are extensively used to treat patients undergoing dialysis.
Total sales of Amgen's Aranesp and Epogen, which are used to treat anemia in chemotherapy patients and patients on kidney dialysis, held steady at $1.
The drugs affected by the safety update are darbepoetin alfa - Aranesp, and epoetin alfa -- Epogen and Procrit, all manufactured by Amgen, Inc.