Lama Daila schreef op 27 november 2020 07:48:
Het is niet zeker dat deze studie er gekomen is op vraag van de FDA en mocht dat toch zo zijn, dan zie ik niet de link met het al dan niet gegeven van feedback van de type A meeting.
Deze studie zou er ook kunnen gekomen zijn op vraag van de EMA:www.ema.europa.eu/en/documents/produc...
Treatment with filgotinib was associated with dose-dependent increases in lipid parameters, including total cholesterol, and high-density lipoprotein (HDL) levels, while low-density lipoprotein (LDL) levels were slightly increased (see section 4.8). LDL cholesterol returned to pre-treatment levels in the majority of patients who started statin
therapy while taking filgotinib. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined
(see section 4.2 for monitoring guidance).
No clinical studies have been performed to investigate interactions with OATP1B1 and OATP1B3 substrates. Therefore, it cannot be excluded that co-administration of filgotinib with OATP1B1 or OATP1B3 substrates may increase their exposure and the risk of adverse events. Co-administration with sensitive OATP1B1 or OATP1B3 substrates (e.g., valsartan, statins
) is therefore not recommended.
Other medicines and Jyseleca
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially if you use medicines that affect your immune system (such as azathioprine, ciclosporin and tacrolimus).
It is also very important to talk to your doctor of pharmacist if you are taking any of the following:
• medicines to treat heart failure, coronary disease or high blood pressure (such as digoxin, diltiazem, carvedilol or valsartan)
• medicines to treat high cholesterol (such as fenofibrate or statins including atorvastatin, pravastatin