Glivec (imatinib) - Novartis Pharmaceuticals UK Limited - revised SPC

Source: eMC (electronic Medicines Compendium) Area: Other Library Updates > SPC Changes Section 4.2 Posology and method of administration has been updated to include information with regard to paediatric use. Specifically, it states that there is no experience in children with CML below 2 years of age. There is limited experience in children with Ph+ ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.   The safety and efficacy of imatinib in children with MDS/MPD, DFSP, GIST and HES/CEL aged less than 18 years of age have not been established in clinical trials. Currently available published data are summarised in section 5.1 but no recommendation on a posology can be made.   Section 5.1 Pharmacodynamic properties has also been updated regarding paediatric patients.   Section 4.8 Undesirable effects has also been updated to include subdural haematoma as an uncommon adverse reaction reported in clinical studies.   Please see link to the SPC for full prescribing information
Source: NeLM - SPC Changes - Category: Drugs & Pharmacology Source Type: news