A REMARKABLE BODY OF EVIDENCE ACROSS DIALYSIS MODALITIES
Safety in therapy
Distinct and recognized formulation
Intravenous iron sucrose contains no dextran or modified dextran
- No test dose required
- No boxed warning
- Consistently ranked the #1 prescribed intravenous iron since 20031
- Long safety record with over 60 years of worldwide clinical experience2-5
- Tolerability in adult HDD patients intolerant to iron dextran, ferric gluconate, or both3-5
Safety studied in adult HDD patients with prior intolerance to intravenous iron dextran3
The safety and efficacy of Venofer (iron sucrose injection, USP) in HDD patients who had experienced intolerance to iron dextran were examined in a single-arm, 2-period, open-label, multicenter study. Following an observation period, patients
received 100 mg Venofer either by intravenous injection or infusion for 10 consecutive dialysis sessions over 3-4 weeks. A test dose was not required.
Study included 23 HDD patients with ongoing intravenous EPO therapy, Hb <11g/dL, and:
- 16 patients had a history of mild reactions to iron dextran
- 7 patients had a history of severe anaphylactoid reactions to iron dextran
- 11 patients had a history of allergy to at least 1 medication in addition to iron dextran
Adverse drug events (ADEs) and blood pressures were recorded at each of 10 dialysis sessions during which Venofer was administered:
- Blood pressure was recorded immediately before and at intervals of 15 and 60 minutes after Venofer administration
- Net blood pressure change was computed, and results were compared with those seen during observation sessions before dialysis and at intervals of 15 and 60 minutes after starting dialysis
Safety results: Venofer was well tolerated3
- There were no anaphylactic reactions, no serious adverse drug reactions, and no patients discontinued from the study due to adverse drug reactions
Three mild adverse events considered related or possibly related to Venofer were reported in 2 patients:
- Metallic taste (1 patient with 2 events)
- Pruritus (1 patient)
- There was no discernible effect on blood pressure during or after Venofer therapy
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%).
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