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MabThera In-Use Storage and Stability in Various Diluents

This article responds to your request for information on the in-use storage and stability of MabThera® (rituximab) in various intravenous diluent bags.

Please refer to the stability information provided in the local label. Any deviation from this information is considered off-label and any treatment decisions based on such deviations are the full responsibility of the prescribing physician.

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Last updated August 10, 2023

Recommendation for storage and stability of prepared Mabthera solution with approved diluents

If diluting Mabthera in 0.9% aqueous normal saline solution (NS)

Follow asceptic technique when diluting Mabthera in 0.9% aqueous solution. Prepared Mabthera IV solution can be stored for 30 days at 2ºC to 8°C and 24 hours at room temperature.[1]

If diluting Mabthera in dextrose 5% in water (D5W)

Follow aspect technique when diluting MabThera in 5% aqueous dextrose solution. Prepared MabThera IV solution can be stored for 24 hours at 2ºC to 8°C plus an additional 12 hours at room temperature.[1]

In-use storage and stability consideration

Mabthera does not contain any anti-microbial preservative.[1] Therefore it is recommended that the prepared infusion solution be administered immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2ºC to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Non-approved diluents for preparing Mabthera IV solution

Roche only performed in-use stability studies with 0.9% NS and D5W solutions.[2] Evaluation of MabThera prepared with other IV diluents have not been performed; therefore, we cannot provide any recommendations on the storage and stability of prepared MabThera IV solution in any other IV diluents. This includes but is not limited to

  • lactated ringers
    • hypotonic IV solutions (e.g. 0.45% NaCl, 1/2NS), and
      • hypertonic IV solutions (e.g. Dextrose 10% in water, D10W).


        1. Roche Internal Regulatory Document (Accessed on 14 Jul 2023).
          1. Roche Internal Communication. (Accessed on 14 Jul 2023).

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