Darbepoetin alfa

Darbepoetin alfa 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. Darbepoetin alfa 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 any known allergy from this medication. It may cause side effects like high blood pressure, and hypersensitivity. You should check your blood pressure regularly while taking this medication. Inform your doctor if there are symptoms of very high blood pressure such as severe headache, problems with your eyesight, nausea, vomiting or fits (seizures). Your doctor may get your blood tests done regularly to monitor the levels of salts (electrolytes such as potassium), haemoglobin and blood cells in your blood. You should stop taking it and consult with doctor if you develop shortness of breath or skin rash. Darbepoetin alfa 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.

• Anemia due to chronic kidney disease • Anemia due to cancer chemotherapy

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.

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 recommended for patietns on hemodialysis Intravenous route recommended for patients on hemodialysis

Your doctor or nurse will give you this medicine. Kindly do not self administer.

If you miss a dose of Darbepoetin alfa, 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.

Common: • High blood pressure • Hypersensitivity

[SAFE] Darbepoetin alfa does not usually affect your ability to drive. Darbepoetin alfa helps in the treatment of anemia that may have occurred due to chronic kidney disease or cancer chemotherapy. It is given as a single injection under your skin. Your doctor may get your blood tests done regularly to monitor the levels of hemoglobin, blood cells and electrolytes such as potassium in your blood. Monitor your blood pressure regularly while taking this medication. Inform your doctor if you notice symptoms of very high blood pressure such as severe headache, problems with your eyesight, nausea, vomiting or fits (seizures). Stop taking Darbepoetin alfa and inform your doctor if you develop shortness of breath or skin rash.

Hypersensitivity, uncontrolled hypertension.

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

[CONSULT YOUR DOCTOR] It is not known whether it is safe to consume alcohol with Darbepoetin alfa. Please consult your doctor.

[CONSULT YOUR DOCTOR] Darbepoetin alfa may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[SAFE IF PRESCRIBED] Darbepoetin alfa is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.

[SAFE IF PRESCRIBED] Darbepoetin alfa is safe to use in patients with kidney disease. No dose adjustment of Darbepoetin alfa is recommended. [CAUTION] Darbepoetin alfa should be used with caution in patients with liver disease. Dose adjustment of Darbepoetin alfa may be needed. Please consult your doctor.

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