QTc interval prolongation occurred in TAGRISSO patients. Of the 411 patients in two Phase II studies, one patient (0.2%) was found to have a QTc greater than 500 msec, and 11 patients (2.7%) had an increase from baseline QTc greater than 60 msec. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life threatening arrhythmia
ການຂະຫຍາຍໄລຍະຫ່າງຂອງ QTc ເກີດຂຶ້ນໃນຄົນເຈັບ TAGRISSO. ຜູ້ປ່ວຍ 411 ໃນສອງໄລຍະການສຶກສາໄລຍະ II, ຜູ້ປ່ວຍຫນຶ່ງຄົນ (0.2%) ພົບວ່າມີ QTc ຫຼາຍກວ່າ 500 msec ແລະຜູ້ປ່ວຍ 11 (2.7%) ມີການເພີ່ມຂື້ນຈາກ QTc ທີ່ສູງກວ່າ 60 msec. ປະຕິບັດຕາມກວດກາໄລຍະເວລາທີ່ມີ ECGs ແລະ electrolytes ໃນຜູ້ທີ່ມີໂຣກ QTc congenital, congestive heart failure, unusual electrolyte, or those who are taking medications known to prolong the QTc interval. ຢຸດເຊົາການປະຕິບັດ TAGRISSO ຢ່າງຖາວອນຕໍ່ຜູ້ປ່ວຍທີ່ພັດທະນາໄລຍະຫ່າງລະຫວ່າງ QTc ມີອາການ / ອາການຂອງຊີວິດທີ່ເປັນໄພຂົ່ມຂູ່ຕໍ່ອາການຫອບຫືດ