darbepoetin alfa

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darbepoetin alfa

Aranesp

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.

References in periodicals archive ?
Darbepoetin alfa (Aranesp *) dosing is not different between the IV and subcutaneous routes of administration, hence, both KDIGO (2012) and CSN (Moist et al., 2013) recommend that this can be administered by either route.
But over the next three years, Amgen stock plummeted precipitously as allegations surfaced that Amgen had withheld results of tests that showed Aranesp was not as safe as initially thought, and the company had been illegally marketing the drug for off-label uses.
Also, tougher guidelines for use over safety concerns related to its off-label usage in cancer patients are squeezing sales of Aranesp, especially in the USA.
According to company shareholder reports, Amgen's other drugs, including the dialysis related drugs Sensipar and Aranesp, bring in another $11.8 billion annually.
The Food and Drug Administration released Friday reducing the dosage for anemia drugs Procrit, Epogen and Aranesp for patients with chronic kidney disease due to increased risks of stroke, blood clots and death.
The three antianemia drugs on the market (Procrit, Aranesp and Epogen) had combined sales of $6.3 billion last year.
McMurray presented a secondary, post hoc analysis of data from TREAT (Trial to Reduce Cardiovascular Events With Aranesp Therapy), an international, double-blind, randomized, placebo-controlled, phase III study involving 4,038 patients with the triad at 623 centers.
The reason for this interest in Actelion is that Amgen revenue fell last year as its top-seller, Enbrel for arthritis, faced new competition and its anemia drugs, Aranesp and Epogen, dropped for the fourth straight year after being linked to heart attacks.
Two major brands of ESAs currently in use in the United States are a recombinant human erythropoietin (rHuEPO) known as epoetin alfa (Procrit, Epogen), and darbepoetin alpha (Aranesp).
According to documents given to The New York Times, "at just one practice in the Pacific Northwest, a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million worth of the company's drugs during 2006.' The report prepared by the FDA scientists said "no evidence indicated that the medicines either improved quality of life in patients or extended their survival, while several studies suggested that the drugs can shorten patients' lives when used at high doses." The drugs involved are Aranesp and Epogen, from Amgen, and Procrit from Johnson & Johnson and are among the world's top-selling drugs with total combined sales of $10 billion.
In 2007, Amgen/Wyeth/Takeda's Enbrel, Centocor/Schering-Plough/Mitsubishi Tanabe's Remicade, Abbott/Eisai's Humira (all TNF-alpha inhibitors), as well as Amgen's Epogen and Aranesp and Johnson & Johnson's Procrit (all ESPs), had combined total sales of $13.7 billion in the United States alone.