• 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

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Smpc.
• Pregnancy and breastfeeding.
• Genital bleeding of unknown aetiology or for reasons other than uterine fibroids.
• Uterine, cervical, ovarian or breast cancer.
• Underlying hepatic disorder.

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.

Reference 3 – Esmya^® SmPC. May 2018.