NESP

NESP

darbepoetin alfa

Manufacturer:

Kyowa Kirin Asia Pacific

Distributor:

Steward Cross
Concise Prescribing Info
Contents
Darbepoetin α
Indications/Uses
Anaemia associated w/ chronic renal failure (CRF); anaemia & reduction of transfusion requirements in patients w/ non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy; anaemia w/ myelodysplastic syndrome, the efficacy & safety of NESP have not been established in patients who are in the intermediate-2 or high risk categories under the International Prognostic Scoring System (IPSS).
Dosage/Direction for Use
CRF patient & patient w/ non-myeloid malignacies receiving chemotherapy Lowest dose that will gradually increase Hb conc to approach a target of not more than 12 g/dL; rate of Hb increase should not exceed 1 g/dL in any 2-wk period. Correction of anaemia Initially 0.45 mcg/kg SC/IV as a single inj once wkly. May be increased by approx 25%. Further increases may be made at 4-wk intervals until the desired response is attained. Maintenance of Hb conc Patient on dialysis & not on dialysis May be dosed wkly or once every 2 wk at the titrated dose to maintain target Hb. For dose adjustment to maintain target Hb, the individual dose may be adjusted at 4-wk intervals until the appropriate Hb level is achieved. Conversion from recombinant human erythropoietin (r-HuEPO) to NESP Initial SC dose: Divide the total wkly r-HuEPO SC dose (u/wk) by 200. Initial IV dose: Divide the total wkly r-HuEPO IV dose (u/wk) by 240. Patient w/ non-myeloid malignancies receiving chemotherapy Initially 2.25 mcg/kg once wkly as single SC inj. Dose adjustment in cancer patients: If Hb approaches 12 g/dL, reduce dose by approx 25-50%. If Hb is >12 g/dL, temporarily w/hold dose & re-initiate when Hb decreases to 11 g/dL at 25-50% below the previous dose. Anaemia w/ myelodysplastic syndrome Adult Usual dose: 240 mcg as a single SC inj once wkly. Dose should be decreased in view of the degree of anaemic symptoms & patient's age.
Contraindications
Hypersensitivity. Known sensitivity to products derived from mammalian cells. Uncontrolled HTN.
Special Precautions
Risk of CV & thrombotic events. Increased risk of death & serious CV events or strokes. Growth factor potential for any tumour type particularly myeloid malignancies. Risk of death when administered to a Hb target 12-14 g/L in patients w/ active malignant disease receiving neither chemotherapy nor radiation therapy. Do not use in patients w/ uncontrolled HTN. Adequately control BP before initiation of therapy; closely monitor & control BP during therapy. Discontinue use if pure red cell aplasia & allergic or anaphylactic reaction occurs, & excessive hemopoiesis develops. History of convulsion. Carefully monitor Hb conc regularly during therapy. Measure Hb conc once a wk when starting therapy or changing dose. Evaluate Fe status before & during therapy. Exclude folic acid or vit B12 deficiencies. Patients w/ underlying haematologic disease (eg, haemolytic & sickle cell anaemia, thalassaemia & porphyria). Discontinue therapy immediately if serious allergic or anaphylactic reaction & severe cutaneous reaction (eg, Stevens-Johnson syndrome/toxic epidermal necrolysis) occur. Pregnancy & lactation. Childn.
Adverse Reactions
Inj site pain; peripheral oedema, fatigue, fever, chest pain, access haemorrhage, influenza-like symptoms, fluid overload, access infection; HTN, hypotension, access vascular thrombosis; headache, dizziness; diarrhoea, vomiting, nausea, abdominal pain, constipation; myalgia, arthralgia, limb & back pain; upper resp infection, dyspnoea, cough, bronchitis; pruritus. CVA/transient ischaemic attack, convulsions, MI. Chronic renal failure, UTI, hypoglycaemia, nasopharyngitis, fall, cellulitis, sinusitis, contusion, rash, skin ulcer. Asthenia, granulocytopenia. Pain, metastatic neoplasm, oedema; insomnia, paresthesia, hypoesthesia; anorexia, dyspepsia; skeletal pain; depression, anxiety; sore throat; alopecia, rash. Rarely, serious allergic reactions; severe cutaneous reaction including blistering, skin exfoliation, erythema multiforme & Stevens-Johnson syndrome/toxic epidermal necrolysis.
ATC Classification
B03XA02 - darbepoetin alfa ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Form
NESP inj 40 mcg/0.5 mL
Packing/Price
10's
Form
NESP inj 120 mcg/0.5 mL
Packing/Price
1's
Form
NESP inj 20 mcg/0.5 mL
Packing/Price
1's
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