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【药品名称】


通用名称：注射用紫杉醇(白蛋白结合型) 
英文名称：Paclitaxel For Injection（Albumin Bound）
 


【成份】


每瓶含紫杉醇100mg及人血白蛋白约900mg。


【性状】


本品为无色或淡黄色澄明粘稠液体。


【适应症】


适用于治疗联合化疗失败的转移性乳腺癌或辅助化疗后6个月内复发的乳腺癌。除非有临床禁忌症，既往化疗中应包括一种蒽环类抗癌药。 


【规格】


100mg


【用法用量】


分散溶解后每毫升悬浮液含5美国紫杉醇。对联合化疗失败的转移性乳腺癌或辅助化疗后复发的乳腺癌患者，建议使用剂量260mg/m2，静脉滴注30分钟，每3周给药一次。
本品给药前不需给予患者抗过敏药预处理。


【不良反应】


肝酶和胆红素升高。红细胞压积和红细胞计数降低，中性粒细胞减少（包括发热性中性粒细胞减少），白细胞减少，血小板减少和淋巴细胞减少，外周神经病变包括感觉神经和运动神经病变，神经病变，呼吸困难，咳嗽，恶心，呕吐腹泻，脱发，皮疹，瘙痒，关节痛，肌肉痛，感染，过敏反应，低血压，黏膜炎，潮红，乏力，胸痛，肺炎，皮疹。其它不良反应参见药品说明书。


【禁忌】


治疗前如患者外周血中性粒细胞数低于1500/mm3，不应给予本药治疗。


【注意事项】


注射用紫杉醇（白蛋白结合型）应该在有化疗经验的医生指导下使用。只有在诊断及治疗设施完善的条件下，治疗过程中发生的并发症才能得到及时和准确的处理。
注射用紫杉醇（白蛋白结合型）的药效特性与其它配方紫杉醇制剂不同，请勿将本药与其他配方紫杉醇制剂互相替换或混合使用。
治疗前如患者的外周血中性粒细胞数低于1500/mm3，不应给药。为监测患者在给药期间可能出现的骨髓毒性，建议对使用本药的所有患者定期进行外周血细胞计数检查。如在给药前中性粒细胞数低于1500/mm3或血小板数低于100000/mm3，不应继续给药。治疗期间如患者出现严重中性粒细胞减少（<500/mm3持续1周或1周以上）或出现严重感觉神经毒性则应将后续疗程的治疗剂量见到220mg/m2.如再次出现上述严重中性粒细胞减少或感觉神经毒性则应再将随后的治疗剂量减到180mg/m3。对于出现3度感觉神经毒性的患者应暂停给药，待神经毒性恢复至≤2度后方可继续治疗，并在后续治疗时需降低剂量。
男性病人如接受本药治疗，建议在治疗期间采取避孕措施。育龄妇女和接受本药治疗，应建议患者避免怀孕。


 


【孕妇及哺乳期妇女用药】


如孕妇使用本药或患者在用药期间怀孕，应权衡对胎儿造成的潜在危险。建议接受本药治疗的妇女停止哺乳。


【儿童用药】


尚不明确。 


【老年患者用药】


尚不明确。 


【药物相互作用】


药代动力学资料证明顺铂后给予本品，本品清除率大约降低30％，骨髓毒性较为严重。同时应用酮康唑影响本品的代谢。 


【药物过量】


尚无相应的解毒药。用药过量最主要的，可预测的并发症包括骨髓抑制，外周神经毒性及黏膜炎。 


【药理毒理】


本品是新型抗微管药物,通过促进微管蛋白聚合抑制解聚,保持微管蛋白稳定,抑制细胞有丝分裂。体外实验证明紫杉醇具有显著的放射增敏作用，可能是使细胞中止于对放疗敏感的G2和M期。 


【药代动力学】


静脉给予紫杉醇,药物血浆浓度呈双相曲线。本品蛋白结合率89％～98％,紫杉醇在肝脏代谢。紫杉醇主要在肝脏代谢，随胆汁进入肠道，经粪便排出体外（90％）。经肾清除只占总清除的1％～8％，肾功能不全者一般紫杉醇在肝肾功能不全的病人体内代谢尚不明确。 


【贮藏】


含药物的药瓶放在原装盒中，室温（20～25℃）条件下避光保存。


【包装】


玻璃瓶装，每盒一瓶。


【生产企业】


公司名称：Celgene Corporation 
公司地址：86 Morris Ave,Summit,NJ 07901,USA 
生产厂商：Fresenius Kabi USA,LLC 
厂商地址：Melrose Park, IL 60160, USA

Abraxane

Generic Name: paclitaxel protein-bound (PAK li TAX el PRO teen-bound)
      Brand Names: Abraxane

What is Abraxane?

Abraxane (paclitaxel) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Abraxane is used in the treatment of breast cancer, lung cancer, and pancreatic cancer.

Abraxane is sometimes given with other cancer medicines.

Important information

You should not receive Abraxane if you have a very low white blood cell count.

You may need frequent medical tests at your doctor's office to be sure Abraxane is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

Abraxane can weaken your immune system. Your blood may need to be tested often.

Before taking this medicine

You should not receive Abraxane if you are allergic to paclitaxel, or if you have:

·         a low white blood cell count; or

·         severe liver disease.

To make sure Abraxane is safe for you, tell your doctor if you have:

·         liver disease;

·         kidney disease;

·         heart disease, heart rhythm disorder; or

·         bone marrow suppression.

Do not use Abraxane if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy during treatment.

Use birth control to prevent pregnancy while you are receiving this medicine, whether you are a man or a woman. Abraxane use by either parent may cause birth defects. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether paclitaxel protein-bound passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving Abraxane.

How is Abraxane given?

Abraxane is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

Abraxane is usually given for breast cancer once every 3 weeks. For lung cancer or pancreatic cancer, this medicine is given in a 21-day or 28-day treatment cycle, and you may only need to receive the medicine during the first 1 to 2 weeks of each cycle. Follow your doctor's dosing instructions very carefully.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when this medicine is injected.

Abraxane can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Abraxane dosing information

Usual Adult Dose of Abraxane for Breast Cancer:

260 mg/m2 administered intravenously over 30 minutes every 3 weeks

Usual Adult Dose of Abraxane for Non-Small Cell Lung Cancer:

100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. The recommended dose of carboplatin is target AUC of 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of paclitaxel protein-bound administration.

The Calvert Formula for calculating carboplatin dosing is: Total carboplatin dose (mg) = (target AUC) x (GFR + 25) with GFR capped at 125 mL/min. For carboplatin target AUC of 6 mg*min/mL the resulting maximum carboplatin dose is 900 mg.

Usual Adult Dose of Abraxane for Pancreatic Cancer:

125 mg/m2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.

Administer gemcitabine immediately after paclitaxel protein-bound on Days 1, 8 and 15 of each 28-day cycle.

Approved indication: Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Abraxane injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Abraxane?

Abraxane can be harmful if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Abraxane side effects

Get emergency medical help if you have any signs of an allergic reaction to Abraxane: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

·         numbness, tingling, pain, or weakness in your hands or feet;

·         sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;

·         low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed;

·         signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

·         dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or

·         severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Abraxane side effects may include:

·         dehydration, low blood cell counts, signs of infection;

·         pale skin, weakness, feeling tired;

·         irregular heartbeats;

·         swelling in your hands or feet;

·         muscle and joint pain;

·         abnormal liver function tests;

·         nausea, vomiting, diarrhea; or

·         hair loss, mild rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Abraxane?

Other drugs may interact with paclitaxel protein-bound, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.