其 他 安 全 警 示
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| The United Kingdom: Mecasermin (Increlex▼): risk of benign and malignant neoplasia (English Only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that cases of benign and malignant neoplasms have been observed among children and adolescents who received treatment with mecasermin.
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.
Mecasermin is a recombinant human insulin-like growth factor 1 (rh-IGF-1). 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.
Healthcare professionals are advised:
- 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
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/mecasermin-increlex-risk-of-benign-and-malignant-neoplasia
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Jan 29, 2020
Issued at HKT 16:00
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