American Regent Logo Corporate Seperator

  • Vial closure is not made with natural rubber latex



NDC Number
Strength
Size
Shelf Pack
Availability
Product Information
Arrow Up 0517-2310-05 200 mg/10 mL
(20 mg Elemental Iron/mL)
10 mL
Single Use Vial
5 In Stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10038438 3975208 2072171 1443423 749713
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
2310-05 5 24 126


Arrow Up 0517-2325-10 50 mg/2.5 mL
(20 mg Elemental Iron/mL)
2.5 mL
Single Use Vial
10 In Stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10092022 4376372 2434124 1668482 508648
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
2325-10 10 80 32


Arrow Up 0517-2340-10 100 mg/5 mL
(20 mg Elemental Iron/mL)
5 mL
Single Use Vial
10 In Stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10015672 2996700 1175769 2266831 375576
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
2340-10 10 80 32


Arrow Up 0517-2340-25 100 mg/5 mL
100 mg/5 mL(20 mg Elemental Iron/mL)
5 mL
Single Use Vial
25 In Stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10012635 3994969 2072189 2493575 549634
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
2340-25 25 16 64




NDC Number
Arrow Up 0517-2310-05
Strength
200 mg/10 mL
(20 mg Elemental Iron/mL)
Size
10 mL
Single Use Vial
Shelf Pack
5
Availability
In Stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10038438 3975208 2072171 1443423 749713
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
2310-05 5 24 126


NDC Number
Arrow Up 0517-2325-10
Strength
50 mg/2.5 mL
(20 mg Elemental Iron/mL)
Size
2.5 mL
Single Use Vial
Shelf Pack
10
Availability
In Stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10092022 4376372 2434124 1668482 508648
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
2325-10 10 80 32


NDC Number
Arrow Up 0517-2340-10
Strength
100 mg/5 mL
(20 mg Elemental Iron/mL)
Size
5 mL
Single Use Vial
Shelf Pack
10
Availability
In Stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10015672 2996700 1175769 2266831 375576
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
2340-10 10 80 32


NDC Number
Arrow Up 0517-2340-25
Strength
100 mg/5 mL
(20 mg Elemental Iron/mL)
Size
5 mL
Single Use Vial
Shelf Pack
25
Availability
In Stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10012635 3994969 2072189 2493575 549634
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
2340-25 25 16 64


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


Venofer® (iron sucrose injection, USP) For Intravenous Use Only INDICATION 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 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. 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. 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 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.


© 2017, American Regent, Inc., A Luitpold Pharmaceuticals, Inc. Company PP-CA-US-0001 (v5.0)     6/2018