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Physicochemical stability of pevonedistat at 50, 100 and 200 µg/mL diluted in 0.9% sodium chloride and at 10 mg/mL in partially used vials
  1. Ralitsa Doncheva1,
  2. Elise D'Huart1,2,
  3. Nathalie Sobalak1,
  4. Jean Vigneron1,2,
  5. Béatrice Demoré1,2,3
  1. 1Pharmacy, CHU Nancy Pharmacy, Vandoeuvre lès Nancy, France
  2. 2Non-profit Association, Infostab, Heillecourt, France
  3. 3Université de Lorraine, Inserm INSPIIRE, Nancy, France
  1. Correspondence to Ralitsa Doncheva, Pharmacy, CHU Nancy Pharmacy, Vandoeuvre lès Nancy, 54500, France; ralitsa.doncheva{at}; Dr Elise D'Huart; E.D'HUART{at}


Objectives Pevonedistat is a new cytotoxic used in association with azacitidine for the treatment of acute myeloid leukaemia and high-risk myelodysplastic syndromes. The manufacturer indicates an 18-hour stability after dilution in dextrose 5% or 0.9% sodium chloride (0.9% NaCl) at 2–8°C. No information is given for re-using vials of pevonedistat.

Our objectives were to study the physico-chemical stability of 50 and 200 µg/mL pevonedistat diluted in 0.9% NaCl, in glass tubes, 100 µg/mL in 0.9% NaCl in polyolefin infusion bags, and 10 mg/mL partially used vials with a Spike. All preparations were stored at 2–8°C, protected from light.

Materials and methods Due to the limited quantity of pevonedistat available for this study, we prepared test solutions at 50 and 200 µg/mL in glass tubes in a small volume of 20 mL. Inorder to verify the absence of a sorption phenomenon of the molecule onto polyolefin, we prepared two infusion bags at 100 µg/mL. We tested concentrated solution at 10 mg/mL. At each analysis time, we tested three samples of each condition by high performance liquid chromatography (HPLC) coupled with a photodiode array detector. Physical stability was evaluated by a visual and sub-visual inspection. We measured pH at each analysis time.

Results Diluted solutions at 50 and 200 µg/mL in tubes and at 100 mg/mL in infusion bags retained more than 95% of the initial concentration for 14 days, the concentrated solution at 10 mg/mL did so for 7 days. No physical changes were detected visually or sub-visually. We found that pH values remained stable.

Conclusion All diluted solutions remained physically and chemically stable for 14 days, the concentrated solution did so for 7 days. No interactions between the polyolefin bag and pevonedistat were demonstrated. This new data allows re-using the concentrated solution of pevonedistat in a commercial glass vial with a Spike, and storing a preparation in case of non-administration.

  • Chemistry, Pharmaceutical
  • Antineoplastic agents
  • Administration, Intravenous

Data availability statement

Data are available in a public, open access repository.

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