There have been significant updates to several sections of the SPC, including the following:

Change to section 4.2 - Posology and method of administration

Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose. However, in these patients caution is recommended. The dose can be reduced if not tolerated. If tolerated, the dose can be increased for lack of efficacy (see sections 4.4 and 5.2).

Change to section 4.4 - Special warnings and precautions for Use

When Glivec is co-administered with other medicinal products, there is a potential for drug interactions.  Caution should be used when taking Glivec with ketoconazole or other strong CYP3A4 inhibitors, CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin or pimozide) or CYP2C9 substrates with a narrow therapeutic window (e.g. warfarin and other coumarin derivatives) (see section 4.5).

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Active substances that may decrease imatinib plasma concentrations:

Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John’s Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure.

Please refer to SPC link below for full information on all changes.