INDICATIONS Venofer® (iron sucrose injection, USP) is an iron replacement product indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD)1: Venofer® is contraindicated in patients with known hypersensitivity to Venofer®.

DOSAGE & ADMINISTRATION

Population Dose Administration
Adult patients Hemodialysis Dependent - Chronic Kidney Disease (HDD-CKD) 100 mg slow IV injection or infusion 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% NaCI over a period of at least 15 minutes, per consecutive hemodialysis session. Venofer should be administered early during the dialysis session. The usual treatment course of Venofer is 1000 mg.
Non-Dialysis Dependent - Chronic Kidney Disease (NDD-CKD) 200 mg slow IV injection or infusion* 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% NaCI over a period of at least 15 minutes. Administer on 5 different occasions over 14 day period.
Peritoneal Dialysis Dependent - Chronic Kidney Disease (PDD-CKD) 300 mg or 400 mg IV infusion 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% NaCI.
Pediatric patients HDD-CKD, PDD-CKD or NDD-CKD 0.5mg/kg slow IV injection or infusion The dosing for iron replacement treatment in pediatric patients with HDD-CKD has not been established. 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 25 mL of 0.9% NaCl and administered over 5 to 60 minutes.

The dosing for iron replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established. 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 25 mL of 0.9% NaCl and administered over 5 to 60 minutes.

*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.



INDICATION
Venofer® (iron sucrose injection, USP) is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Venofer® is contraindicated in patients with known hypersensitivity to Venofer.
WARNINGS AND PRECAUTIONS
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.
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 rate of administration and/or total dose delivered.
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.
ADVERSE REACTIONS
The most common adverse reactions (≥2%) following the administration of Venofer are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain and peripheral edema. Additional adverse reactions include infusion site pain or burning, graft complications, and nasopharyngitis, sinusitis, upper respiratory tract infections and pharyngitis.
In pediatric patients, more than 50% of the patients experienced at least one treatment-emergent reaction. The most common adverse reactions (≥2%) were headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, renal transplant, nausea, arteriovenous fistula thrombosis, hypotension and hypertension.
In post-marketing safety studies of Venofer in 1,051 patients with HDD-CKD, adverse reactions reported by > 1% were cardiac failure congestive, sepsis and dysgeusia.
Because adverse reactions from post-marketing experience are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In addition to potential serious hypersensitivity reactions, the following adverse reactions have been identified during post-approval use of Venofer® (iron sucrose injection, USP): bronchospasm, dyspnea, convulsions, light-headedness, confusion, angioedema, swelling of the joints, hyperhidrosis, bradycardia and chromaturia.
Symptoms associated with Venofer total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema and cardiovascular collapse. These adverse reactions have occurred up to 30 minutes after the administration of Venofer injection. Reactions have occurred following the first dose or subsequent doses of Venofer. Slowing the infusion rate may alleviate symptoms.
Injection site discoloration has been reported following extravasation. Assure stable intravenous access to avoid extravasation.
PP-VE-US-0001 10/2016
To report adverse events, please contact American Regent at 1-800-734-9236.
You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.


REFERENCES:
1. Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 2015.
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Venofer® is manufactured under license from Vifor (International) Inc., Switzerland.
© 2017 American Regent, Inc., a Luitpold Pharmaceuticals, Inc. company