Rapamune (sirolimus) tablets and oral solution - Pfizer Limited - Revised SPC

Source: eMC (electronic Medicines Compendium) Area: Other Library Updates > SPC Changes Section 4.5 Interaction with other medicinal products and other forms of interaction has been updated to include potential interactions with CYP3A4 inhibitors, which may decrease the metabolism of sirolimus and increase sirolimus blood levels. Such inhibitors include e.g. certain antifungals (e.g. clotrimazole, fluconazole, itraconazole, voriconazole), certain antibiotics (e.g.  troleandomycin, telithromycin, clarithromycin), certain protease inhibitors (e.g. ritonavir, indinavir, boceprevir, telaprevir),  nicardipine, bromocriptine, cimetidine, and danazol.   Section 4.8 Undesirable effects has also been updated to include ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) as potential side effects.   Please see link to the SPC for full prescribing information  
Source: NeLM - SPC Changes - Category: Drugs & Pharmacology Source Type: news