Venofer (iron sucrose)

Venofer (iron sucrose) Injection is an iron replacement product used to treat iron deficiency anemia in people with kidney disease. Venofer is usually given with another medication to promote the growth of red blood cells (such as Aranesp, Epogen, or Procrit).

Venofer is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD).

Common side effects of Venofer include:

• muscle cramps,
• nausea,
• vomiting,
• stomach pain,
• strange taste in the mouth or decreased sense of taste,
• diarrhea,
• constipation,
• headache,
• cough,
• sore throat,
• sinus pain,
• congestion,
• back pain,
• joint pain,
• dizziness,
• weakness,
• tired feeling,
• anxiety,
• ear pain,
• swelling of the arms/legs, or
• injection site reactions (pain, swelling, burning, irritation, or redness).

Tell your doctor if you experience serious side effects of Venofer including:

• abdominal pain,
• chest pain,
• irregular heartbeat (arrhythmias),
• pressure in the chest,
• severe headache and blurred vision (hypertension), or
• problems with your dialysis access site (graft).

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. 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. 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. 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. 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. 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.

Venofer may reduce the absorption of concomitantly administered oral iron preparations.

Iron deficiency anemia during pregnancy should be treated. Untreated IDA in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

Published data from randomized controlled studies and prospective observational studies on the use of Venofer in pregnant women have not reported an association of Venofer and adverse developmental outcomes. However, these studies did not include women exposed during the first trimester of pregnancy and were not designed to assess the risk of major birth defects. Maternal adverse events reported in these studies are similar to those reported during clinical trials in adult males and non-pregnant females.

A published report of 78 breastfeeding women who received 300 mg of intravenous iron sucrose over 3 days (infant age not reported) did not report on the safety of iron sucrose in breastfed infants; however adverse reactions in breastfed infants were not reported. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for Venofer and any potential adverse effects on the breastfed child from Venofer or from the underlying maternal condition.