What is the stability duration of diluted Venofer (iron sucrose) after refrigeration?

Stability of Diluted Venofer After Preparation

Diluted Venofer is stable for 7 days when stored at either controlled room temperature (25°C ± 2°C) or under refrigeration (4°C ± 2°C), according to FDA-approved stability data. 1

Storage Guidelines for Diluted Venofer

Syringe Preparation Stability

• When diluted with 0.9% NaCl at concentrations ranging from 2-10 mg elemental iron per mL (or undiluted at 20 mg/mL) and stored in plastic syringes, Venofer remains physically and chemically stable for 7 days 1
• This stability applies to both controlled room temperature storage (25°C ± 2°C) and refrigerated storage (4°C ± 2°C) 1

IV Bag Preparation Stability

• When added to IV infusion bags (PVC or non-PVC) containing 0.9% NaCl at concentrations of 1-2 mg elemental iron per mL, Venofer is stable for 7 days at controlled room temperature (25°C ± 2°C) 1
• Do not dilute to concentrations below 1 mg/mL 1
• Do not mix Venofer with other medications or add to parenteral nutrition solutions 1

Critical Storage Requirements

Undiluted Product Storage

• Store original vials at 20-25°C (68-77°F), with excursions permitted to 15-30°C (59-86°F) 1
• Do not freeze 1
• Contains no preservatives 1

Administration Timing

• Venofer should be administered as soon as possible after being removed from refrigeration 2
• Once prepared, use within the 7-day stability window to ensure optimal safety and efficacy 1

Important Safety Considerations

Pre-Administration Inspection

• Inspect visually for particulate matter and discoloration prior to infusion 1
• Discard if particulate matter or discoloration is observed 1

Monitoring Requirements

• Resuscitation facilities should be available during administration, as anaphylaxis may occur with IV iron preparations 2
• Monitor vital signs during and after infusion 3, 4