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  • Preservative free
  • Vial closure is not made with natural rubber latex

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  NDC# Strength Supplied As Shelf Pack Product Info Availability
Strength:

200 mg/10 mL
(20 mg of Elemental Iron/mL)

Supplied As:

10 mL
Single Dose Vial

NDC#: 0517-2310-05
0517-2310-05

200 mg/10 mL
(20 mg of Elemental Iron/mL)

10 mL
Single Dose Vial

5 In Stock
  • Shelf Pack 5
  • Availability In Stock

Wholesaler Numbers

  • ABC/SAP 10038438
  • Cardinal 3975208
  • HD Smith 2072171
  • McKesson 1443423
  • Morris & Dickson 749713

Case Information

  • Unit of Sale NDC 2310-05
  • Order Size 5
  • Case Size 24
  • Case Per Tier 126
Strength:

50 mg/2.5 mL
(20 mg of Elemental Iron/mL)

Supplied As:

2.5 mL
Single Dose Vial

NDC#: 0517-2325-10
0517-2325-10

50 mg/2.5 mL
(20 mg of Elemental Iron/mL)

2.5 mL
Single Dose Vial

10 In Stock
  • Shelf Pack 10
  • Availability In Stock

Wholesaler Numbers

  • ABC/SAP 10092022
  • Cardinal 4376372
  • HD Smith 2434124
  • McKesson 1668482
  • Morris & Dickson 508648

Case Information

  • Unit of Sale NDC 2325-10
  • Order Size 10
  • Case Size 80
  • Case Per Tier 32
Strength:

100 mg/5 mL
(20 mg of Elemental Iron/mL)

Supplied As:

5 mL
Single Dose Vial

NDC#: 0517-2340-10
0517-2340-10

100 mg/5 mL
(20 mg of Elemental Iron/mL)

5 mL
Single Dose Vial

10 In Stock
  • Shelf Pack 10
  • Availability In Stock

Wholesaler Numbers

  • ABC/SAP 10015672
  • Cardinal 2996700
  • HD Smith 1175769
  • McKesson 2266831
  • Morris & Dickson 375576

Case Information

  • Unit of Sale NDC 2340-10
  • Order Size 10
  • Case Size 80
  • Case Per Tier 32
Strength:

100 mg/5 mL
(20 mg of Elemental Iron/mL)

Supplied As:

5 mL
Single Dose Vial

NDC#: 0517-2340-25
0517-2340-25

100 mg/5 mL
(20 mg of Elemental Iron/mL)

5 mL
Single Dose Vial

25 In Stock
  • Shelf Pack 25
  • Availability In Stock

Wholesaler Numbers

  • ABC/SAP 10012635
  • Cardinal 3994969
  • HD Smith 2072189
  • McKesson 2493575
  • Morris & Dickson 549634

Case Information

  • Unit of Sale NDC 2340-25
  • Order Size 25
  • Case Size 16
  • Case Per Tier 64

Venofer® and the Venofer® logo are trademarks of Vifor (Internation) Inc., Switzerland

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For Intravenous Use Only INDICATIONS AND USAGE 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 Adult Patients: The most common adverse reactions (≥2%) include 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. Pediatric Patients: The most common adverse reactions (≥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 casual relationship to drug exposure. 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.
  • Immune system disorders: anaphylactic-type reactions, angioedema
  • Psychiatric disorders: confusion
  • Nervous system disorders: convulsions, collapse, light-headedness, loss-of-consciousness
  • Cardiac disorders: bradycardia
  • Vascular disorders: shock
  • 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—Pregnancy Category B
Venofer should be used during pregnancy only if clearly needed.
Nursing Mothers
Because many drugs are excreted in human milk, caution should be exercised when Venofer is administered to a nursing woman
Pediatric Use
Safety and effectiveness of Venofer for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established.
Safety and effectiveness of Venofer for iron maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied. Venofer has not been studied in patients younger than 2 years of age. 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.
OVERDOSAGE
No data are available regarding overdosage of Venofer in humans. Excessive dosages of Venofer may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer Venofer to patients with iron overload.
For additional Safety Information, please see Full Prescribing Information. You are encouraged to report Adverse Drug Events (ADEs) 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.