Safety update for INCRELEX 10mg/ml Solution for Injection (mecasermin)
13 Dec 2019
INCRELEX 10mg/ml Solution for Injection (mecasermin) MA Number EU/1/07/402/001:
Risk of benign and malignant neoplasia
Ipsen Pharma, in agreement with the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency would like to inform you of the following:
• Cases of benign and malignant neoplasms have been observed among children and adolescents who received treatment with mecasermin in the post-marketing setting.
• Mecasermin should be permanently discontinued if benign or malignant neoplasia develops, and expert medical care should be sought.
• Mecasermin is contraindicated in children and adolescents with active or suspected neoplasia, or any condition or medical history which increases the risk of benign or malignant neoplasia.
• Mecasermin should only be used in the treatment of severe primary IGF-1 deficiency and the maximum dose of 0.12 mg/kg given twice daily should not be exceeded. Available data suggest that the risk of neoplasia may be higher in patients who were given mecasermin without IGF-1 deficiency, or who receive mecasermin at higher than recommended doses resulting in increase of IGF-1 levels above normal