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Nesp 20 mcg/0.5ml pre-filled syringes

Marketed by Dexa Medica

Ingredients in every 0.5 ml

Darbepoetin alfa 20 mcg

Each package contains

1 syringe of 0.5 ml

Dosage form

pre-filled syringe

Dosage formSyringe; pre-filled

Flavour

None

W.H.O. classification

B03X
B03X

A.T.C. Level 1

Anatomical Main group

B - Blood and blood forming organs
B03X

A.T.C. Level 2

Therapeutic subgroup

B03 - Antianemic Preparations
B03X

A.T.C. Level 3

Pharmacological subgroup

B03X - Other Antianemic Preparations in ATC

Available in

Indonesia

Warnings

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

SAFE IF PRESCRIBEDThis item is safe for use while operating heavy machinery.

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

Indication

Anemia associated with chronic kidney disease (CKD)
in patients on hemodialysis or not on dialysis

Dosage

UP TO 18 YEARS
The safety of NESP in babies with low birthweight, neonates, suckling babies, infants or children has not been established.

18 YEARS OLD AND ABOVE
Hemodialysis patients
— Initial dose:
The usual dose of NESP in adults is 20 µg as darbepoetin alfa (genetic recombination), to be administered as a single intravenous injection once weekly.

— Initial dose at the switching from erythropoietin preparations (epoetin alfa (genetic recombination), epoetin beta (genetic recombination), etc):
The usual dose of NESP in adults is 15–60 µg as darbepoetin alfa (genetic recombination), to be administered as a single intravenous injection once weekly.

— Maintenance dose:
When correction of anemia is achieved, the usual dose of NESP in adults is 15–60 µg as darbepoetin alfa (genetic recombination), to be administered as a single intravenous injection once weekly. If alleviation of anemia is maintained by once weekly injection, the frequency of administration can be changed to once every two weeks with an initial dose set to be two-fold of the dose in the once weekly injection. In this case, the usual dose in adults is 30–120 µg administered as a single intravenous injection once every two weeks.

In all cases, the dose should be adjusted in view of the degree of anemic symptoms and the patient’s age, and should not exceed 180 µg as a single injection.

Initiate treatment when the hemoglobin level is less than 10 g/dl. If the hemoglobin level approaches or exceeds 11 g/dl, reduce or interrupt the dose of darbepoetin alfa (genetic recombinant).


Patients with chronic kidney disease not on dialysis
— Initial dose:
The usual dose of NESP in adults is 30 µg as darbepoetin alfa (genetic recombination), to be administered as a single injection once every two weeks subcutaneously or intravenously.

— Initial dose at the switching from erythropoietin preparations (epoetin alfa (genetic recombination), epoetin beta (genetic recombination), etc):
The usual dose of NESP in adults is 30–120 µg as darbepoetin alfa (genetic recombination), to be administered as a single injection once every two weeks subcutaneously or intravenously.

— Maintenance dose:
When correction of anemia is achieved, the usual dose of NESP in adults is 30–120 µg as darbepoetin alfa (genetic recombination), to be administered as a single injection once every two weeks subcutaneously or intravenously. If alleviation of anemia is maintained by once every two weeks injection, the frequency of administration can be changed to once every four weeks with an initial dose set to be two-fold of the dose in the once every two weeks injection. In this case, the usual dose in adults is 60–180 µg administered as a single injection once every four weeks subcutaneously or intravenously.

In all cases, the dose should be adjusted in view of the degree of anemic symptoms and the patient’s age, and should not exceed 180 µg as a single injection.

Consider initiating darbepoetin alfa treatment only when the hemoglobin level is less than 10 g/dl and the following consideration apply: (1) the rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and (2) reducing the risk of alloimmunization and/or other RBC transfusion–related risks is a goal. If the hemoglobin level exceeds 10 g/dl, reduce or interrupt the dose of darbepoetin alfa, and use the lowest dose of darbepoetin alfa sufficient to reduce the need for RBC transfusions.

ELDERLY PATIENTS
When NESP is used in elderly patients, parameters such as the blood pressure, hemoglobin concentration and hematocrit level should be frequently measured so that the dosage and the frequency of administration can be appropriately adjusted. The elderly generally have reduced physiological function and are likely to have cardiovascular complications such as hypertension.