Nesp

Nesp

darbepoetin alfa

Manufacturer:

Kyowa Kirin

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Darbepoetin α
Indications/Uses
Anaemia associated w/ chronic renal failure. Anaemia & reduction of transfusion requirements in patients w/ non-myeloid malignancies where anaemia develops due to concomitant chemotherapy. Anemia w/ myelodysplastic syndrome.
Dosage/Direction for Use
SC/IV Patients for renal anemia, CRF patients Individualized dosage. Correction of anaemia Initially 0.45 mcg/kg as single inj once wkly. Patients not on dialysis Initially 0.75 mcg/kg as single SC inj once every 2 wk. Dose may be increased by approx 25% if increase in Hb is inadequate & Fe stores are adequate. Further increase may be made at 4-wk intervals until desired response is attained. Maintenance of Hb conc: May be dosed wkly or once every 2 wk at the titrated dose. Patients not on dialysis Dose may be administered as SC mthly using an initial dose equal to twice the previous dose, once every 2 wk dose. Individual dose may be adjusted at 4-wk intervals until appropriate Hb level is achieved. Dose adjustment: If Hb is increasing & approaching 120 g/L Reduce dose by approx 25%. If rise in Hb is >10 g/L in 2 wk Reduce dose by 25%. Patients w/ non-myeloid malignancies receiving chemotherapy Initially 500 mcg or 6.75 mcg/kg once every 3 wk as single SC inj. Alternatively, 2.25 mcg/kg once wkly. Continue therapy for approx 4 wk after the end of chemotherapy or until Hb conc approach 120 g/L. Dose adjustment: If Hb approaches 120 g/L Reduce dose by 25-50%. If Hb >10 g/L in a 2 wk period Reduce dose by 25-50%. Patients receiving treatment on a wkly basis w/ inadequate Hb increase Double the dose to 4.5 mcg/kg once wkly. Anemia w/ myelodysplastic syndrome Adult 240 mcg as single SC inj once wkly. Dose adjustment: Excessive hemopoiesis (Hb conc >11 g/dL) Reduce dose by approx 50%. If after dose reduction, the Hb fall <9 g/dL Dose may be increased 2-fold. Max dose: 240 mcg as a single inj.
Contraindications
Hypersensitivity. Known sensitivity to products derived from mammalian cells. Uncontrolled HTN.
Special Precautions
Immediately discontinue if serious allergic or anaphylactic reaction occurs. Discontinue in any patient w/ pure red cell aplasia & evaluate for the presence of neutralising Ab(s) to treatment, native erythropoietin & any other recombinant erythropoietin. Temporarily discontinue if response of excessive hemopoiesis develops. CRF patients w/ relative hyporesponsiveness to erythropoiesis stimulating agents. Do not switch to other erythropoiesis stimulating agents. Increased risk of serious arterial & venous thromboembolic events eg, MI, stroke, CHF, haemodialysis graft occlusion; death. Use the lowest dose that will gradually increase Hb conc. May act as growth factor potential for any tumour type particularly myeloid malignancies. Increased risk of death when administered to a Hb target 120-140 g/L in patients w/ active malignant disease receiving neither chemotherapy nor radiation therapy. Do not use in patients w/ uncontrolled HTN. Adequately monitor & control BP prior to initiation & during therapy. History of convulsion. Carefully monitor Hb conc & BP regularly during therapy. Measure Hb conc once a wk when starting therapy or changing dose. Administer Fe in patients w/ Fe deficiency. Evaluate Fe status before & during therapy. Exclude folic acid or vit B12 deficiencies. Patients w/ underlying hematologic disease eg, haemolytic & sickle cell anemia, thalassaemia & porphyria. Pregnancy & lactation. Paed patients.
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. Non-cardiac chest pain, pain, metastatic neoplasm, oedema; insomnia, paresthesia, hypoesthesia; anorexia, dyspepsia; skeletal pain; depression, anxiety; sore throat; alopecia.
MIMS Class
Haematopoietic Agents / Supportive Care Therapy
ATC Classification
B03XA02 - darbepoetin alfa ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Form
Nesp inj 120 mcg/0.5 mL
Packing/Price
1's
Form
Nesp inj 20 mcg/0.5 mL
Packing/Price
1's
Form
Nesp inj 30 mcg/0.5 mL
Packing/Price
1's
Form
Nesp inj 40 mcg/0.5 mL
Packing/Price
1's
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