Mabthera SC Room Temperature Stability
Diluted Mabthera (rituximab) solutions can remain at room temperature for up to 24 hours, though refrigerated storage at 2°C to 8°C is strongly preferred. 1
Storage and Handling Guidelines
Diluted Solutions
- Diluted rituximab solutions for infusion may be stored at room temperature for a maximum of 24 hours 1
- Refrigerated storage at 2°C to 8°C (36°F to 46°F) is the preferred method and extends stability to 24 hours under refrigeration 1
- The FDA label explicitly states that "diluted solutions should be stored refrigerated (2°C to 8°C)" because rituximab solutions do not contain a preservative 1
Preparation Requirements
- Use appropriate aseptic technique when preparing rituximab 1
- Dilute to a final concentration of 1 mg/mL to 4 mg/mL in 0.9% Sodium Chloride or 5% Dextrose Injection 1
- Discard any unused portion left in the vial after preparation 1
Important Clinical Considerations
Quality Control Before Administration
- Always inspect the solution visually before administration - rituximab should be a clear, colorless liquid 1
- Do not use if particulates or discoloration are present 1
- This visual inspection is critical after any period at room temperature 1
Common Pitfalls to Avoid
- Never exceed 24 hours at room temperature - beyond this timeframe, the medication should be discarded due to lack of preservatives 1
- Do not assume all thermolabile drugs have similar stability profiles - brand-specific data must be prioritized as stability varies even among products with the same active ingredient 2
- Avoid storing in areas with temperature fluctuations or direct sunlight, even within the 24-hour window 1
Context from Broader Evidence
- Recent comprehensive reviews of thermolabile medications demonstrate that many refrigerated drugs maintain adequate stability at room temperature for clinically acceptable periods 3, 2
- However, the 24-hour limit for rituximab is conservative and appropriate given the absence of preservatives in the formulation 1