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 ?
(President and CEO: Ken Unemoto, 'Kyowa Kirin Frontier') will launch 'Darbepoetin Alfa Injection Syringe [KKF]' in Japan on August 5.
The phase 3 randomised, double-blind, active-controlled conversion study assessed the efficacy and safety of vadadustat compared to darbepoetin alfa in 323 Japanese hemodialysis subjects with anemia due to CKD who had been receiving ESA therapy prior to study screening, with a treatment duration of 52 weeks.
[5] Medical Officer Clinical Review: Darbepoetin Alfa (Aranesp) for The Treatment of Anemia Associated with Chronic Renal Failure, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Md, USA, 2001.
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.
Patients received either darbepoetin alfa to a target Hb of 130 g/L or placebo with rescue doses of darbepoetin only if the Hb was less than 90 g/L.
Hyderabad, June 20 -- The Hetero Group, one of the largest manufacturers and suppliers of Active Pharmaceutical Ingredients (APIs) to the Indian pharmaceutical industry, today announced the launch of its first biosimilar product in India, darbepoetin alfa. This launch marks a significant advancement for Hetero in a biosimilars market expected to grow to US$ 24B in the next five years.
Four-fifths of the population (224/279, 80.3%) were receiving ESA therapy at the time of study entry, most frequently darbepoetin alfa (n = 98, 35.1%) or C.E.R.A.
Amgen allegedly pressured pharmacists to recommend Aransep (darbepoetin alfa) for nursing home residents who did not have anaemia associated with chronic renal failure, and distributed materials and sponsored programmes promoting this off-label use of the medication.
In 2002, most patients were receiving epoetin alfa (65%); however, by 2008, most patients (67%) were receiving darbepoetin alfa (see Table 2).
Darbepoetin alfa, marketed as Arandesp, and epoetin alfa, marketed as Epogen o and Procrit, are the ESAs approved in the United States; they are administered as often as one to three times per week.
The initial dose of darbepoetin alfa is 2.25 pg [kg.sup.-1] QWK; the dose can be increased to 4.5 [micro]g [kg.sup.-1] QWK if there is no response.