Drug Detail:Venofer injection (Iron sucrose (injection) [ eye-urn-soo-krose ])
Generic Name: IRON SUCROSE 20mg in 1mL
Dosage Form: injection, solution
Drug Class: Iron products
Venofer must only be administered intravenously either by slow injection or by infusion. The dosage of Venofer is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron.
2.1 Mode of Administration
Administer Venofer only intravenously by slow injection or by infusion. The dosage of Venofer is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron.
Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD)
Administer Venofer 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 Venofer early during the dialysis session (generally within the first hour). The usual total treatment course of Venofer is 1000 mg. Venofer treatment may be repeated if iron deficiency reoccurs.
Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD)
Administer Venofer 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 Venofer, 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).]Venofer treatment may be repeated if iron deficiency reoccurs.
Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD)
Administer Venofer 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 Venofer in a maximum of 250 mL of 0.9% NaCl [see How Supplied/Storage and Handling (16.2).] Venofer treatment may be repeated if iron deficiency reoccurs.
Pediatric Patients (2 Years of Age and Older) with HDD-CKD for Iron Maintenance Treatment
For iron maintenance treatment: Administer Venofer 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].) Venofer treatment may be repeated if necessary.
The dosing for iron replacement treatment in pediatric patients with HDD-CKD has not been established.
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 Venofer 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).] Venofer 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.
