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详细处方信息以本药内容附件PDF文件(201411522214319.pdf)的“原文Priscribing Information”为准
适应证和用途
KADCYLA是一种靶向HER2抗体和微管抑制剂结合物适用于,作为单药,为有HER2-阳性,转移乳癌,既往接受曲妥珠单抗和一种紫衫烷类,分开或联合应用患者的治疗。患者应有以下任一情况:
(1)对转移疾病以前接受治疗,或
(2)完成辅助治疗期间或6个月内疾病复发。(1)
剂量和给药方法
(1)只为静脉输注。不要静推注或丸注。不要使用葡萄糖(5%)溶液。 (2.3)
(2)KADCYLA的推荐剂量是3.6 mg/kg每3周(21-天周期)静脉输注给药直至疾病进展或不能接受毒性。不要给予剂量大于3.6 mg/kg的KADCYLA。不要替代KADCYLA或用曲妥珠单抗。(2.1)
(3)不良事件的处理(输注相关反应,肝毒性,左心室功能障碍,血小板减少,肺毒性或周围神经病变)可能需要暂时中断,减低剂量,或终止KADCYLA治疗。(2.2)
剂型和规格
在单次使用小瓶冻干粉含100 mg每小瓶或160 mg每小瓶. (3)
禁忌证
无。(4)
警告和注意事项
(1)肺毒性:在被诊断有间质性肺病或肺炎患者中永久终止KADCYLA。(2.2,5.4)
(2)输注相关反应,超敏性反应:输注期间和后监视体征和症状。如发生重要输注相关反应或超敏性反应,减慢或中断输注和给予适当医学治疗。对危及生命输注相关反应永久终止KADCYLA。(2.1,2.2,5.5)
(3)血小板减少:每次给予KADCYLA前监视血小板计数。适当时调整剂量。(2.2,5.6)
(4)神经毒性:监视体征和症状。对经受3或4级周围神经病变患者暂时不用给药。(2.2,5.7,13.2)
(5)HER2检验:由有测试能力的实验室用FDA-批准的检验进行检验。(5.8)
不良反应
用KADCYLA (n=884被治疗患者)最常见不良反应(频数> 25%)是疲乏,恶心,肌肉骨骼痛,血小板减少,头痛,转氨酶增加,和便秘。(6.1)
为报告怀疑不良反应,联系Genentech电话1-888-835-2555或FDA电话1-800-FDA-1088或www.fda.gov/medwatch.
在特殊人群中使用
(1)哺乳母亲:终止哺乳或终止KADCYLA考虑到药物对母亲的重要性。(8.3)
(2)生殖潜能妇女:忠告女性关于预防和计划妊娠。鼓励患者参加母亲妊娠注册通过联系1-800-690-6720)。(5.3,8.1,8.6)
Who is KADCYLA for?
KADCYLA® is approved to treat HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin®) and a taxane. Prior treatment could have been for the initial treatment of breast cancer or for the treatment of cancer that had spread to other parts of the body.
Important Safety Information
What is the most important safety information I should know about KADCYLA?
KADCYLA is not the same medicine as trastuzumab (Herceptin).
Liver problems
KADCYLA may cause severe liver problems that can be life-threatening.
Symptoms of liver problems may include vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), stomach pain, dark urine, or itching
Heart problems
KADCYLA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Symptoms may include swelling of the ankles or legs, shortness of breath, cough, rapid weight gain of greater than 5 lbs in less than 24 hours, dizziness or loss of consciousness, or irregular heart beat
Pregnancy
Receiving KADCYLA during pregnancy can result in the death of an unborn baby and birth defects. Birth control should be used while you receive KADCYLA and for 6 months after your last dose of KADCYLA
If you are exposed to KADCYLA during pregnancy, contact your healthcare provider right away; you are also encouraged to enroll in the MotHER Pregnancy Registry by calling 1 (800) 690-6720
If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping KADCYLA
Contact your doctor right away if you experience symptoms associated with these side effects.
What are the additional possible serious side effects of KADCYLA?
Lung problems
KADCYLA may cause lung problems, including inflammation of the lung tissue, which can be life-threatening. Signs of lung problems may include trouble breathing, cough, tiredness, and fluid in the lungs
Infusion-related reactions
Symptoms of an infusion-related reaction may include one or more of the following: the skin getting hot or red (flushing), chills, fever, trouble breathing, low blood pressure, wheezing, tightening of the muscles in the chest around the airways, or a fast heartbeat. Your doctor will monitor you for infusion-related reactions
Low platelet count
Low platelet count may happen during treatment with KADCYLA. Platelets help your blood to clot. Signs of low platelets may include easy bruising, bleeding, and prolonged bleeding from cuts. In mild cases there may not be any symptoms
Nerve damage
Symptoms may include numbness and tingling, burning or sharp pain, sensitivity to touch, lack of coordination, muscle weakness, or loss of muscle function
Skin reactions around the infusion site
KADCYLA may leak from the vein or needle and cause reactions such as redness, tenderness, skin irritation, or pain or swelling at the infusion site. If this happens, it is more likely to happen within 24 hours of the infusion
How will my doctor know if KADCYLA is right for me?
You must have a HER2 test to determine if your cancer is HER2-positive before taking KADCYLA, because benefit has been shown only in patients whose tumors are HER2-positive.
What are the most common side effects of KADCYLA?
The most common side effects seen in people taking
KADCYLA are:
Tiredness
Nausea
Pain that affects the bones, muscles, ligaments, and tendons
Low platelet count
Headache
Liver problems
Constipation