Venofer® iron sucrose injection, USP Millions Prescribed.
Millions Treated.®
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A REMARKABLE BODY OF EVIDENCE ACROSS DIALYSIS MODALITIES

More choices in dosing and administration without a required test dose

Adult therapeutic options

At 1 g total treatment course1:

Indication Dosing Administration Rate Period
HDD-CKD 100 mg slow intravenous injection or over 2 to 5 minutes at each consecutive HD session
100 mg intravenous injection diluted in a maximum of 100 mL of 0.9% NaCl over at least 15 minutes at each consecutive HD session
PDD-CKD 2 infusions of 300 mg in a maximum of 250 mL of 0.9% NaCl followed by over 1.5 hours Days 1 and 14
one 400 mg infusion in a maximum of 250 mL of 0.9% NaCl over 2.5 hours Day 28
  • Venofer treatment may be repeated if iron deficiency reoccurs1

Pediatric therapeutic options

For iron maintenance in pediatric patients ≥2 years of age1:

Indication Dosing Administration Rate Period
HDD-CKD 0.5 mg/kg, not to exceed 100 mg per dose, given undiluted by slow intravenous injection or over 5 minutes every 2 weeks for 12 weeks
0.5 mg/kg, not to exceed 100 mg per dose, diluted in 25 mL of 0.9% NaCl over 5 to 60 minutes every 2 weeks for 12 weeks
PDD-CKD patients on erythropoietin therapy 0.5 mg/kg, not to exceed 100 mg per dose, given undiluted by slow intravenous injection or over 5 minutes every 4 weeks for 12 weeks
0.5 mg/kg, not to exceed 100 mg per dose, diluted in 25 mL of 0.9% NaCl over 5 to 60 minutes every 4 weeks for 12 weeks
  • Venofer treatment may be repeated if necessary1

Convenience Factors

  • No test dose required
  • Easy calculation in therapeutic dosing
  • Two size vials to meet practice needs:
    • 100 mg/5 mL single use vial
    • 50 mg/2.5 mL single use vial
  • Established J code for ease of reimbursement
    • HCPCS Code: J1756
    • 1 mg = 1 service unit

INDICATION:

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

IMPORTANT SAFETY INFORMATION:

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer (iron sucrose injection, USP). 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.

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.

Venofer is contraindicated in patients with known hypersensitivity to Venofer. Do not administer to patients with evidence of iron overload.

In multi-dose efficacy studies in hemodialysis dependent (HDD)–CKD patients (N=231), the most frequent adverse events (>2%) whether or not related to Venofer administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%), hypertension (6.5%), chest pain (6.1%), pain in extremity (5.6%), and diarrhea (5.2%).

In the study of peritoneal dialysis dependent (PDD)-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer, reported by ≥2% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract infections, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).

In a randomized open-label dose ranging trial of iron maintenance treatment in pediatric patients with CKD on stable erythropoietin therapy, 57% of the Venofer treated patients (27/47) receiving 0.5 mg/kg Venofer experienced a treatment–emergent adverse reaction, 11% of which were serious. The most common treatment–emergent adverse reactions (>2% of patients) in all patients were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%).

Please see full Prescribing Information.