AIFA calls to the correct use of the Atossisclerol medicine, in particular the foam formulation.

Summary:

• Preliminary results of an ongoing post-authorization safety study (PASS – Post Authorization Safety Study) have highlighted an unjustified wide off-label use of the medicine Atossisclerol in patients undergoing sclerosing therapy.
• The Atoxysclerol medicine in the form of foam should be administered only in a 3% concentration, only according to the indication approved by AIFA, specifically sclerosing therapy of great saphenous veins (VGS) with dimensions of 4-8 mm, and with the method of preparation described in the Summary of Product Characteristics (SmPC).
• The Atossisclerol medicine in the liquid formulation should be used in the concentrations and according to the following indications authorized by AIFA, following the recommendations contained in the RCP:
  • ATOXISCLEROL 0.25% and 0.5% Sclerosing therapy of small varicose veins (reticular varices) and telangiectasias.
  • ATOXYSCLEROL 1% Sclerosing therapy of small varicose veins (reticular varices) and of the central branch of telangiectasias.
  • ATOXISCLEROL 2% Sclerosing therapy of medium-sized varicose veins.
  • ATOXISCLEROL 3% Sclerosing therapy of large caliber varicose veins and hemorrhoids (first and second degree). 

Published on: 29 November 2023