Venofer

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

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.

Injection: 100 mg/5 mL (20 mg/mL) in single-dose vials.

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Hypersensitivity Reactions

  [see Warnings and Precautions (

  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 Venofer. 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 Venofer immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer 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 ].

  )]

• Hypotension

  [see Warnings and Precautions (

  5.2 Hypotension

  Venofer may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer. Hypotension following administration of Venofer may be related to the rate of administration and/or total dose administered

  [see Dosage and Administration , Warnings and Precautions , and Adverse Reactions ].

  )]

• Iron Overload

  [see Warnings and Precautions (

  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 Venofer require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Do not administer Venofer 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 and Overdosage ].

  )]

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