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Venofer^® Safety Profile

No boxed warning

No test dose or premedication required^†

100% dextran-free IV iron

Safe for use in pediatric patients (2 years of age and older)^‡

^*For the 25 years since FDA approval, Venofer has been consistently available to the millions of patients in the US who need it. From June 2024 to November 2024 the product was on allocation but shipping weekly.

^†Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer.

^‡The dosing for iron replacement treatment in pediatric patients with HDD-, NDD-, or PDD-CKD has not been established.

HDD-CKD=hemodialysis-dependent chronic kidney disease; NDD-CKD=non-dialysis-dependent chronic kidney disease; PDD-CKD=peritoneal dialysis-dependent chronic kidney disease.

REFERENCE

1. IQVIA. NSP Audit from January 2020 to January 2025.

IMPORTANT SAFETY INFORMATION

Read the Important Safety Information

CONTRAINDICATIONS

Known hypersensitivity to Venofer.

WARNINGS AND PRECAUTIONS

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.

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 rate of administration and/or total dose delivered.

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.

ADVERSE REACTIONS

Adult Patients: The most common adverse reactions in clinical trials (≥2% and greater than comparator) include diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema.

Pediatric Patients: The most common adverse reactions in clinical trials (≥2%) are headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, nausea, arteriovenous fistula thrombosis, hypotension, and hypertension.

Post-Marketing Experience

Because these reactions 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 post-marketing safety studies of Venofer in 1,051 patients with hemodialysis-dependent chronic kidney disease (HDD-CKD), adverse reactions reported by >1% were cardiac failure congestive, sepsis, and dysgeusia.

Immune system disorders: anaphylactic-type reactions, angioedema
Psychiatric disorders: confusion
Nervous system disorders: convulsions, collapse, light-headedness, loss of consciousness
Cardiovascular system: bradycardia, shock, acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction
Respiratory, thoracic, and mediastinal disorders: bronchospasm, dyspnea
Musculoskeletal and connective tissue disorders: back pain, swelling of the joints
Renal and urinary disorders: chromaturia
General disorders and administration site conditions: hyperhidrosis

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.

DRUG INTERACTIONS

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

USE IN SPECIFIC POPULATIONS

Pregnancy

Untreated iron deficiency anemia (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.

Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Venofer), which may cause fetal bradycardia, especially during the second and third trimester.

Pediatric Use

Safety and effectiveness of Venofer for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent chronic kidney disease (CKD) have not been established.

Geriatric Use

Dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

INDICATION AND USAGE

Venofer^® (iron sucrose) injection, USP is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).

For additional Safety Information, please see Full Prescribing Information.

You are encouraged to report adverse drug events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

REF-0262 6/2022

Venofer® Safety Profile