How long can Mabthera (rituximab) 1400mg subcutaneous stay at room temperature for an adult patient with rheumatoid arthritis or non-Hodgkin's lymphoma?

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Mabthera 1400mg Subcutaneous Room Temperature Stability

Diluted Mabthera (rituximab) solutions for infusion may be stored at room temperature for up to 24 hours, though refrigerated storage at 2°C to 8°C is preferred since the solution contains no preservative. 1

Storage Guidelines from FDA Label

  • Diluted rituximab solutions have been demonstrated stable for 24 hours at room temperature after the initial 24-hour refrigerated storage period 1

  • The preferred storage method is refrigeration at 2°C to 8°C (36°F to 46°F) for up to 24 hours after dilution, followed by the additional 24-hour room temperature stability window 1

  • Total stability window: 48 hours maximum (24 hours refrigerated + 24 hours at room temperature) 1

Critical Storage Requirements

  • Rituximab solutions lack preservatives, which is why refrigerated storage is strongly recommended over room temperature storage 1

  • The product should be a clear, colorless liquid - do not use if particulates or discoloration are present 1

  • Dilution must be performed using aseptic technique to a final concentration of 1-4 mg/mL in either 0.9% Sodium Chloride or 5% Dextrose Injection 1

Common Pitfalls to Avoid

  • Do not assume extended room temperature stability beyond 24 hours - the absence of preservatives limits microbial protection 1

  • Discard any unused portion left in the vial after withdrawal - do not attempt to store opened vials 1

  • Do not mix or dilute with other drugs in the infusion bag 1

  • No incompatibilities exist with polyvinylchloride or polyethylene bags, so standard IV bags are appropriate 1

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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