5 ML iron sucrose 20 MG/ML Injection [Venofer]

INDICATIONS AND USAGE Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). ( 1 )

DOSAGE AND ADMINISTRATION Population Dose Adult Patients Hemodialysis Dependent- Chronic Kidney Disease (HDD-CKD) ( 2.2 ) 100 mg slow intravenous injection or infusion Non-Dialysis Dependent- Chronic Kidney Disease (NDD-CKD) ( 2.3 ) 200 mg slow intravenous injection or infusion Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) ( 2.4 ) 300 mg or 400 mg intravenous infusion Pediatric patients HDD-CKD ( 2.5 ), PDD- CKD or NDD-CKD ( 2.6 ) 0.5 mg/kg slow intravenous injection or infusion 2.1 Mode of Administration Administer Iron Sucrose Injection only intravenously by slow injection or by infusion. The dosage of Iron Sucrose Injection is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron. 2.2 Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) Administer Iron Sucrose Injection 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session [ see How Supplied/Storage and Handling ( 16.2 ) ] . Administer Iron Sucrose Injection early during the dialysis session (generally within the first hour). The usual total treatment course of Iron Sucrose Injection is 1000 mg. Iron Sucrose Injection treatment may be repeated if iron deficiency reoccurs. 2.3 Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) Administer Iron Sucrose Injection 200 mg undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 mL of 0.9% NaCl over a period of 15 minutes. Administer on 5 different occasions over a 14 day period. There is limited experience with administration of an infusion of 500 mg of Iron Sucrose Injection, diluted in a maximum of 250 mL of 0.9% NaCl, over a period of 3.5 to 4 hours on Day 1 and Day 14 [ see How Supplied/Storage and Handling ( 16.2 ) ] . Iron Sucrose Injection treatment may be repeated if iron deficiency reoccurs. 2.4 Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) Administer Iron Sucrose Injection in 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions each of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. Dilute Iron Sucrose Injection in a maximum of 250 mL of 0.9% NaCl [ see How Supplied/Storage and Handling ( 16.2 ) ] . Iron Sucrose Injection treatment may be repeated if iron deficiency reoccurs. 2.5 Pediatric Patients (2 Years of Age and Older) with HDD-CKD for Iron Maintenance Treatment. For iron maintenance treatment: Administer Iron Sucrose Injection at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every two weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 0.9% NaCl at a concentration of 1 to 2 mg/mL and administered over 5 to 60 minutes. Do not dilute to concentrations below 1 mg/mL [ see How Supplied/Storage and Handling ( 16.2 ) ] . Iron Sucrose Injection treatment may be repeated if necessary. The dosing for iron replacement treatment in pediatric patients with HDD-CKD has not been established. 2.6 Pediatric Patients (2 Years of Age and Older) with NDD-CKD or PDD-CKD who are on Erythropoietin Therapy for Iron Maintenance Treatment For iron maintenance treatment: Administer Iron Sucrose Injection at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every four weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 0.9% NaCl at a concentration of 1 to 2 mg/mL and administered over 5 to 60 minutes. Do not dilute to concentrations below 1 mg/mL [ see How Supplied/Storage and Handling ( 16.2 ) ] . Iron Sucrose Injection treatment may be repeated if necessary. The dosing for iron replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.

WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Iron Sucrose Injection administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Iron Sucrose Injection when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. ( 5.1 ) • Hypotension: May cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration ( 5.2 ) • Iron Overload: Regularly monitor hematologic responses during therapy. Do not administer to patients with iron overload.( 5.3 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Iron Sucrose Injection. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Iron Sucrose Injection immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Iron Sucrose Injection administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Iron Sucrose Injection when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion [ see Adverse Reactions ( 6.1 and 6.2 ) ] . 5.2 Hypotension Iron Sucrose Injection may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Iron Sucrose Injection. Hypotension following administration of Iron Sucrose Injection may be related to the rate of administration and/or total dose administered [ see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.2 ) ] . 5.3 Iron Overload Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. All adult and pediatric patients receiving Iron Sucrose Injection require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Do not administer Iron Sucrose Injection to patients with evidence of iron overload. Transferrin saturation (TSAT) values increase rapidly after intravenous administration of iron sucrose; do not perform serum iron measurements for at least 48 hours after intravenous dosing [ see Dosage and Administration ( 2 ) and Overdosage ( 10 ) ] .

CONTRAINDICATIONS Known hypersensitivity to Iron Sucrose Injection • Known hypersensitivity to Iron Sucrose Injection ( 4 )

Mechanism of Action Iron Sucrose Injection is an aqueous complex of poly-nuclear iron (III)-hydroxide in sucrose. Following intravenous administration, Iron Sucrose Injection is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells. The iron in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells.