Revised SPCs: Prograf (tacrolimus) hard capsules and concentrate for solution for infusion
SPC updated to include new information on interaction with CYP3A4 inhibitors/inducers, information on nephrotoxicity and instruction to avoid concurrent use with drugs with nephrotoxic effects, and the new adverse reaction ‘Posterior reversible encephalopathy syndrome’.
Source:
electronic Medicines compendium
SPS commentary:
Section 6.6 now states that based on immunosuppressive effects of tacrolimus, inhalation or direct contact with skin or mucous membranes by the formulations for injection, powder or granule contained in tacrolimus products should be avoided during preparation. If such contact occurs, wash the skin and flush the affected eye or eyes.