Risk of benign and malignant neoplasms with mecasermin
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Risk of benign and malignant neoplasms with mecasermin Mecasermin (Increlex) is associated with cases of benign and malignant neoplasms (neoplasia) in children and adolescents, says Dr Manjinder Bains from Ipsen Pharmaceuticals. In a recent "Dear Healthcare Professional" communication, Ipsen Pharma’s Dr Bains (Medical Director, UK & Ireland), in agreement with the EMA and Ireland’s Health Products Regulatory Authority, informed healthcare personnel that "a higher number of cases of benign and malignant neoplasms have been identified in patients receiving mecasermin in the postmarketing setting with respect to the background incidence in this patient population. These cases represented a variety of different malignancies and included rare malignancies usually not seen in children". This recombinant human insulin-like growth factor 1 (rh-IGF-1) product is approved for long-term treatment of growth failure in children and adolescents aged 2–18 years with confirmed severe primary IGF-1 deficiency. Current data have suggested that "IGF-1 plays a role in malignancies within all organs and tissues" and that "physicians should therefore be vigilant for any potential malignancy and the [Increlex] prescribing information should be strictly adhered to", highlighted Dr Bains. As such, the Summary of Product Characteristics for Increlex and the relevant educational materials for both physicians and patients are being updated to reflect the following information: • 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 medical history or condition that increases their risk of benign or malignant neoplasia. • Mecasermin should only be used in the treatment of severe primary IGF-1 deficiency, and the maximum daily dose (0.12 mg/kg twice daily) should not be exceeded. Bains M. INCRELEX 10mg/ml Solution for Injection (mecasermin) MA Number EU/1/07/402/001: Risk of benign and malignant neoplasia. Internet Document : [2 pages], 12 Dec 2019. Available from: URL: https://www.hpra.ie/docs/default803444441 source/default-document-library/important-safety-information
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Reactions 4 Jan 2020 No. 1785
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