Mecasermin (Increlex▼): risk of benign and malignant neoplasia
Cases of benign and malignant neoplasms have been observed among children and adolescents who received treatment with mecasermin. Do not use mecasermin in children or adolescents with active or suspected neoplasia or with any condition or medical history that increases the risk of benign or malignant neoplasia.
Advice for healthcare professionals:
- cases of benign and malignant neoplasms have been observed among children and adolescents who received treatment with mecasermin
- permanently discontinue mecasermin if a benign or malignant neoplasm develops
- mecasermin is contraindicated in children and adolescents with active or suspected neoplasia and in any condition or medical history that increases the risk of benign or malignant neoplasia
- mecasermin is licensed only for the treatment of severe primary insulin-like growth factor 1 (IGF-1) deficiency and the recommended maximum dose is 0.12 mg/kg given twice daily – data suggest the risk of neoplasia is higher when used outside of the licensed indication or dose (see details below)
- report all suspected adverse drug reactions associated with the use of mecasermin to the Yellow Card scheme
Background
Mecasermin is a recombinant human insulin-like growth factor 1 (rh-IGF-1). It is indicated for the long-term treatment of growth failure in children and adolescents aged 2–18 years with confirmed severe primary insulin-like growth factor 1 deficiency (primary IGFD). The recommended maximum dose is 0.12 mg/kg given twice a day.
Review of cases of neoplasia
An EU review identified an increased incidence of benign and malignant tumours in patients receiving mecasermin in the post-marketing setting compared with the background incidence in this patient population. These cases represented a variety of different malignancies and included rare cancers not usually seen in children. Most cases occurred in patients treated outside the authorised indication or exceeding the maximum dose, however some were reported within the authorised indication and posology for mecasermin.
Current knowledge of IGF-1 biology suggests that IGF-1 may play a role in malignancies within all organs and tissues. The role of the IGF family in the genesis of human benign and malignant neoplasia has been observed in several epidemiological and pre-clinical studies. Physicians should therefore be vigilant for any potential malignancy.
Mecasermin is already contraindicated in active or suspected neoplasia. Following the review, the contraindication will be expanded to children or adolescents with any condition or medical history that increases the risk of benign or malignant neoplasia and this will be added into the product information. A letter has also been sent from the manufacturer to prescribers and dispensers of mecasermin.
In rare situations where a physician considers that that there is a special clinical need to use mecasermin outside of the licensed indication or recommended posology, then this decision should be made in consultation with the patient and caregivers after they have been fully informed of the potential benefits and risks. Physicians should be particularly vigilant for any potential malignancies in these situations.
Reporting suspected adverse drug reactions to mecasermin
Suspected adverse drug reactions associated with use of mecasermin should be reported to the Yellow Card scheme. Healthcare professionals are asked to report all adverse drug reactions suspected to be associated with black triangle products through the Yellow Card scheme.
Article citation: Drug Safety Update volume 13, issue 6: January 2020: 3.