When given at home it is particularly important for the patient and caregivers to possess the knowledge on how cytostatics can be handled safely. This may include whether or not breaking of the tablet is possible, precautions during pregnancy, caregivers avoiding contact with the skin, the use of gloves and possibly the use of facemask when breaking the tablets. Which information is needed for the product information may vary between the different cytostatics.
The Norwegian Medicines Agency therefore ask the holders of marketing authorisations for relevant products to evaluate their SmPCs and Patient Information leaflets to make sure that all relevant information on breaking and handling is covered. See SmPC guideline (section 4.3 and 6.6) and QRD template with annotations.
It is of utmost importance that the information on safe handling is reflected in the Patient Information leaflet.
The evaluation of own product information should be done within 1st of January 2017
Any necessary changes to the product information should be applied for and classified in line with the classification guidelines.
NB: Letters to the individual relevant marketing authorization holders will not be sent in this case.