Darbesis

Darbesis25 mcg/0.42 ml

SC Injection

Darbepoetin Alfa

Beacon Pharmaceuticals Ltd.

Product Code : 4439
MRP 2840.00
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Medicine overview

Indications of Darbesis 25 mcg/0.42 ml

Anemia Due To Chronic Kidney Disease: Darbesis 25 mcg/0.42 ml is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.Anemia Due To Chemotherapy In Patients With Cancer: ... Read moreAnemia Due To Chronic Kidney Disease: Darbesis 25 mcg/0.42 ml is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.Anemia Due To Chemotherapy In Patients With Cancer: Darbesis 25 mcg/0.42 ml is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

Theropeutic Class

Haematopoietic Agents

Pharmacology

Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.

Dosage & Administration of Darbesis 25 mcg/0.42 ml

Usual Adult Dose for Anemia Associated with Chronic Renal Failure: Chronic Kidney Disease (CKD) Patients Not on Dialysis: Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate Comments: Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal. CKD Patients on Dialysis: Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate Comments: Initiate treatment when hemoglobin is less than 10 g/dL. IV route is recommended for patients on hemodialysis. Usual Adult Dose for Anemia Associated with Chemotherapy: Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks Duration of therapy: Until completion of chemotherapy course Comments: Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions. Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.

Dosage of Darbesis 25 mcg/0.42 ml

Usual Adult Dose for Anemia Associated with Chronic Renal Failure: Chronic Kidney Disease (CKD) Patients Not on Dialysis: Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate Comments: Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal. CKD Patients on Dialysis: Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate Comments: Initiate treatment when hemoglobin is less than 10 g/dL. IV route is recommended for patients on hemodialysis. Usual Adult Dose for Anemia Associated with Chemotherapy: Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks Duration of therapy: Until completion of chemotherapy course Comments: Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions. Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.

Interaction of Darbesis 25 mcg/0.42 ml

Antagonism of hypotensive effect and increased risk of hyperkalemia with ACE inhibitors and angiotensin II receptor antagonists. Ethanol.

Contraindications

Darbepoetin is contraindicated in patients with: Uncontrolled hypertension Pure red cell aplasia (PRCA) that begins after treatment with Darbepoetin or other erythropoietin protein drugs  Serious allergic reactions to Darbepoetin 

Side Effects of Darbesis 25 mcg/0.42 ml

Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism; Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with cancer; Hypertension; Seizures; Serious allergic reaction; Severe Cutaneous Reactions

Pregnancy & Lactation

Pregnancy Category C. It is not known whether Darbesis 25 mcg/0.42 ml is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Darbesis 25 mcg/0.42 ml is administered to a nursing woman.

Precautions & Warnings

Pregnancy and lactation, children. Hypertension; history of seizures; hepatic impairment; sickle cell anaemia; sudden stabing migraine-like pain (warning sign of hypotensive crisis); exclude other causes of anaemia; ischaemic vascular disease; thrombocytosis; epilepsy; malignant disease; increase in heparin dose may be needed; increased risk of thrombosis when used for anaemia before orthopedic surgery; CV disease including recent MI/cerebrovascular accident. Monitor haemoglobin, BP and electrolytes; platelet count for 1st 8 wk.

Overdose Effects of Darbesis 25 mcg/0.42 ml

Darbepoetin overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Darbepoetin dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs

Storage Conditions

Store at 2°C to 8°C. Do not freeze. Do not shake. Protect from light; store Darbesis 25 mcg/0.42 ml in the carton until use. Do not use Darbesis 25 mcg/0.42 ml that has been shaken or frozen.

Use In Special Populations

Pediatric Use: Pediatric Patients With CKD: Darbepoetin safety and efficacy were similar between adults and pediatric patients with CKD when Darbepoetin was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Darbepoetin Pediatric Patients With Cancer: The safety and efficacy of Darbepoetin in pediatric patients with cancer have not been established. Geriatric Use: Of the 1801 patients with CKD in clinical studies of Darbepoetin, 44% were age 65 and over, while 17% were age 75 and over. Of the 873 patients in clinical studies receiving Darbepoetin and concomitant cancer chemotherapy, 45% were age 65 and over, while 14% were age 75 and over. No differences in safety or efficacy were observed between older and younger patients.

Drug Classes

Haematopoietic Agents

Mode Of Action

Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.

Pregnancy

Pregnancy Category C. It is not known whether Darbesis 25 mcg/0.42 ml is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Darbesis 25 mcg/0.42 ml is administered to a nursing woman.

Pediatric Uses

Pediatric Use: Pediatric Patients With CKD: Darbepoetin safety and efficacy were similar between adults and pediatric patients with CKD when Darbepoetin was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Darbepoetin Pediatric Patients With Cancer: The safety and efficacy of Darbepoetin in pediatric patients with cancer have not been established. Geriatric Use: Of the 1801 patients with CKD in clinical studies of Darbepoetin, 44% were age 65 and over, while 17% were age 75 and over. Of the 873 patients in clinical studies receiving Darbepoetin and concomitant cancer chemotherapy, 45% were age 65 and over, while 14% were age 75 and over. No differences in safety or efficacy were observed between older and younger patients.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.