Monday, March 23, 2020
Flexipharm Austrading, the UK specialty pharmaceutical company focused on supplying the NHS with Better, Critical Care Medicines, announced an important improvement to the 'Summary of Product Characteristics' for its differentiated arsenic trioxide injection product, Arsenic Trioxide Phebra (1mg/ml concentrate for solution for infusion).
The MHRA has granted approval for Section 6.3 of the Summary of Product Characteristics to be changed, such that:
"After dilution in intravenous solutions, Arsenic Trioxide Phebra is chemically and physically stable for 48 hours at 15°C-30°C and 72 hours at refrigerated (2°C-8°C) temperatures. From a microbiological point of view, the product must be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions."
Previously, after dilution in intravenous solutions, the chemical and physical stability of the product was 24 hours at 15°C-30°C and 48 hours at refrigerated (2°C-8°C) temperatures.
Arsenic Trioxide Phebra is the first arsenic trioxide product available in a vial presentation and the only vial presentation with these timelines for storage prior to use. The vial presentation removes the very real and common risk of sharps injuries when opening glass ampoules and saves NHS pharmacists time to make up infusions as no filter needles or filter straws are needed.
Commenting on today's development, Michael Clark, Founder and Director of Flexipharm Austrading, said: "We are very pleased to be making this important product update. Feedback from NHS specialist pharmacists indicates that in-use stability time is of great importance for products like Arsenic Trioxide. Given as an infusion, the product is routinely prepared prior to the patient attending the hospital. If, for any reason, the planned timing for the infusion is delayed, the amount of time the product can be stored prior to use is critical and may help avoid the need to discard product and start manufacturing again."