- Liver function tests must be performed before starting treatment. Treatment must not be initiated if transaminases (ALT or AST) exceed 2 × ULN (isolated or in combination with bilirubin >2 × ULN)1
- During treatment, liver function tests must be performed monthly during the first two treatment courses. For further treatment courses, liver function must be tested once before each new treatment course and when clinically indicated1
- In addition liver testing should be performed 2–4 weeks after treatment has stopped1
In order to ensure that patients are adequately informed on the possible risks of liver injury and the implemented risk minimisation measures, a patient card is to be provided in each package of Esmya. Click here to download it.
ALT, alanine transaminase; AST, aspartate aminotransferase; ULN, upper limit of normal
1. ESMYA®. Summary of Product Characteristics. May 2018; 2. Donnez J, et al. Fertil Steril 2016;105:165–73.e4