Darbagen 40 - sc_injection Darbepoetin alfa - 40mcg/0.4ml 1 Pre-Filled Syringe(s) / Pre-Filled Syringe ACI Limited Introduction: Darbagen 40 is used in the treatment of anemia that may have occurred due to chronic kidney disease or chemotherapy. It works by stimulating the bone marrow to produce more red blood cells. Darbagen 40 is a medicine that needs to be used with utmost care because it can lead to serious side effects. It is important that you seek treatment from a doctor who is experienced in providing this medicine therapy. You should follow all the directions of doctor strictly. It is given under the supervision of a healthcare professional. However, you should not take it, if you have... Uses of Darbagen 40: Anemia due to chronic kidney diseaseAnemia due to cancer chemotherapy Side effects of Darbagen 40: High blood pressureHypersensitivity How to use Darbagen 40: Your doctor or nurse will give you this medicine. Kindly do not self administer. How Darbagen 40 works: Darbagen 40 is an erythropoiesis-stimulating agent (ESA). It works by stimulating the bone marrow (soft tissue inside the bones which produces red blood cells) to produce more red blood cells. What if you forget to take Darbagen 40?: If you miss a dose of Darbagen 40, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. Indication: Anaemia of chronic renal failure, Anaemia in chemotherapy patients Adult Dose: Chronic Kidney Disease-Associated Anemia CKD not on dialysis Recommended starting dose: 0.45 mcg/kg IV/SC q4weeks Consider initiating ESA treatment only when the hemoglobin level is 1 g/dL in 2-week period) Discontinue if no response after 8 weeks Child Dose: Chronic Kidney Disease-Associated Anemia Initiate treatment when the hemoglobin level is <10 g/dL If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose Recommended starting dose for pediatric patients (<18 yr) is 0.45 mcg/kg SC or IV qWeek Patients not receiving dialysis may also be initiated at a dose of 0.75 mcg/kg q2Week Chemotherapy-related Anemia Safety and efficacy not established Renal Dose: Chronic Kidney Disease-Associated Anemia CKD not on dialysis Recommended starting dose: 0.45 mcg/kg IV/SC q4weeks Consider initiating ESA treatment only when the hemoglobin level is <10 g/dL If the hemoglobin level exceeds 10 g/dL, reduce or interrupt ESA dose and use the lowest dose sufficient to reduce the need for red blood cell transfusions CKD on dialysis Initiate ESA treatment when the hemoglobin level is <10 g/dL If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of ESA Recommended starting dose: 0.45 mcg/kg IV or SC qWeek or 0.75 mcg/kg q2weeks; the IV route is... Contraindication: Hypersensitivity, uncontrolled hypertension. Mode of Action: Darbepoetin alfa is a biosynthetic form of erythropoietin. Recombinant human erythropoietin with sialic acid additions to enhance stability; stimulates erythropoiesis via division & differentation of progenitor cells in bone marrow to induce the release of reticulocytes from the bone marrow into the bloodstream to become erythrocytes. Precaution: 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. Lactation: not known if excreted in breast milk, use caution Side Effect: >10% Cancer patients Fatigue (33%),Diarrhea (22%),Edema (21%),Fever (19%),Dizziness (14%),Arthralgia (13%),Headache (12%),Death (10%) Chronic renal failure patients Infectious disease (24%),Hyper/Hypotension (20%),Spasm (17%),Upper respiratory infection, Headache (15%),Diarrhea, Vomiting (14%),Nausea (11%),Peripheral edema, Dyspnea (10%),Abdominal pain (10%) 1-10% Cancer patients Myalgia (8%),Hypertension (3.7%),Pneumonia (3%),Dyspnea (2%),Vomiting (2%),Pulmonary embolism (1.3%) Chronic renal failure patients Arthralgia, Cough, Fatigue (9%),Limb pain (8%),Dizziness, Fever (7%),Death (6%),Edema (6%),Anemia, DVT, red cell aplasia (5.6%),Cardiac arrest, Cardiac dysrhythmia, Congestive heart failure (5%),Myocardial infarction, CVA(2%) <1% Cancer patients Hypertensive encephalopathy (0.6%),Seizure (0.6%),Chronic renal failure patients,Hypertensive encephalopathy (<1%),Seizure (<1%),Transient ischemic attack (<1% ) Frequency Not Defined Tumor progression,Venous thromboembolism,Immune hypersensitivity reaction (rare ),Injection site... Pregnancy Category Note: Pregnancy Limited available data on pregnant women are insufficient to determine a drug-associated risk of major birth defects or miscarriage; in animal reproductive and developmental toxicity studies, drug increased early post-implantation loss at doses approximating clinical recommended starting doses; consider benefits and risks for the mother and possible risks to fetus when prescribing to a pregnant woman Lactation There is no information regarding presence of drug in human milk, effects on breastfed child, or on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects... Interaction: Antagonism of hypotensive effect and increased risk of hyperkalemia with ACE inhibitors and angiotensin II receptor antagonists. Ethanol.