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5PSQ-031 Evaluation of the safety and tolerance of the commercial presentation of cyclosporine 0.1% collyrium
  1. AM Martínez Soto,
  2. M Garcia Coronel,
  3. P Ortiz Fernandez,
  4. JM Marco Puig,
  5. C Pastor Mondéjar,
  6. P Fernandez-Villacañas Fernandez,
  7. L Rentero Redondo,
  8. C Caballero Requejo,
  9. C Iniesta Navalon,
  10. I Salar Valverde,
  11. E Urbieta Sanz
  1. Hospital General Universitario Reina Sofía, Pharmacy, Murcia, Spain


Background and importance Cyclosporine collyrium is used in the treatment of severe keratitis in adult patients with xerophthalmia who do not improve despite treatment with eye drops. The current commercial presentation has a concentration of 0.1% although there is also a 0.05% formulation.

Aim and objectives The purpose was to evaluate the safety of 0.1% cyclosporine collyrium and assess the rate of patients who do not tolerate this presentation and its causes.

Material and methods This was a retrospective observational study. It was carried out in a model hospital in this area. All patients treated with cyclosporine collyrium between January and September 2021 were included.

Demographic (sex and age) data were collected from the computerised clinical history.

A questionnaire was produced for the clinic interview of the external patients who had adverse reactions after treatment with 0.1% cyclosporine collyrium such that they had to switch to the 0.05% formulation. In this questionnaire the reason for the switch, the type of adverse reaction, severity and time of appearance (immediate/late) were included.

Results 137 patients who picked up 0.1% cyclosporine collyrium from the Pharmacy External Patients Unit were included, 84.67% were women and the mean age was 64 years.

11.67% of the patients suffered some adverse reaction which forced them to switch from the 0.1% cyclosporine presentation to the 0.05% cyclosporine compound made by the Pharmacy Unit.

Within the described adverse reactions, 100% of patients exhibited stinging, 31.25% irritation, 25.00% pain, 12.50% blurry vision, 31.25% reddening, 12.5% swelling, 31.25% photosensitivity and 18.75% dry eyes.

100% of the adverse reactions occurred immediately following application of the collyrium. The adverse reactions were classified as severe (68.75%), moderate (25%) and mild (6.25%) by the patients.

The adverse reactions were reversible and autolimited.

The switch to our compounding was well tolerated in 100% of cases.

Conclusion and relevance The 0.1% cyclosporine presentation is safe and it was well tolerated by most of our patients; only 11.67% experienced an adverse reaction.

Moreover, these patients did not suffer any adverse reaction with our preservative-free 0.05% cyclosporine Pharmacy Unit compound, thus we do not know if the adverse reactions were due to the higher cyclosporine concentration or some of its excipients. Further research is needed.

Conflict of interest No conflict of interest

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