Inlyta 1 mg 3mg, 5 mg & 7mg film-coated tablets - Ireland[爱尔兰药品]

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Inlyta 1 mg 3mg, 5 mg & 7mg film-coated tablets(十)

2013-10-05 16:47:18 来源: 作者: 【大中小】浏览:9415次评论:0条

	0
Aspartate aminotransferase increased	1.1	0.3	0
Alkaline phosphatase increased	1.4	0	0
Amylase increased	1.7	0	0
Uncommon	Blood bilirubin increased	0.6	0	0
Uncommon	Creatinine increased	0.6	0	0

a National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0
b See Description of selected adverse reactions section
c Fatal (Grade 5) cases were reported
d Adverse reaction is all-causality incidence
e Including acute renal failure
Description of selected adverse reactions
Thyroid dysfunction (see section 4.4)
In a controlled clinical study with axitinib for the treatment of patients with RCC, hypothyroidism was reported in 18.4% of patients and hyperthyroidism was reported in 0.6% of patients. Thyroid stimulating hormone (TSH) increased was reported as an adverse reaction in 4.5% of patients receiving axitinib. During routine laboratory assessments, in patients who had TSH < 5 μU/mL before treatment, elevations of TSH to ≥ 10 μU/mL occurred in 32.2% of patients receiving axitinib.
Venous embolic and thrombotic events (see section 4.4)
In a controlled clinical study with axitinib for the treatment of patients with RCC, venous embolic and thrombotic adverse reactions were reported in 1.9% of patients receiving axitinib. Grade 3/4 venous embolic and thrombotic adverse reactions were reported in 1.7% of patients receiving axitinib (including pulmonary embolism, deep vein thrombosis, and retinal vein occlusion/thrombosis). Fatal pulmonary embolism was reported in one patient (0.3%) receiving axitinib.
Arterial embolic and thrombotic events (see section 4.4)
In a controlled clinical study with axitinib for the treatment of patients with RCC, Grade 3/4 arterial embolic and thrombotic adverse reactions were reported in 1.1% of patients receiving axitinib. The most frequent arterial embolic and thrombotic event was transient ischemic attack (0.8%). A fatal cerebrovascular accident was reported in one patient (0.3%) receiving axitinib. In monotherapy studies with axitinib (N=699), arterial embolic and thrombotic adverse reactions (including transient ischemic attack, myocardial infarction, and cerebrovascular accident) were reported in 1.0% of patients receiving axitinib.
Polycythaemia (see Elevation of haemoglobin or haematocrit in section 4.4)
In a controlled clinical study with axitinib for the treatment of patients with RCC, polycythaemia was reported as an adverse reaction in 0.3% of patients receiving axitinib. Routine laboratory assessments detected elevated haemoglobin above ULN in 9.7% of patients receiving axitinib. In four clinical studies with axitinib for the treatment of patients with RCC (N=537), elevated haemoglobin above ULN was observed in 13.6% receiving axitinib.
Haemorrhage (see section 4.4)
In a controlled clinical stu