通用中文 | 注射用紫杉醇 白蛋白结合型 | 通用外文 | paclitaxel protein-bound |
品牌中文 | 品牌外文 | Abraxane | |
其他名称 | |||
公司 | 新基(Celgene) | 产地 | 德国(Germany) |
含量 | 100mg | 包装 | 1瓶/盒 |
剂型给药 | 储存 | 室温 | |
适用范围 | 非小细胞肺癌一线治疗转移性胰腺癌和乳腺癌。包括黑色素瘤、膀胱癌、卵巢癌以及乳腺癌、肺癌的。 |
通用中文 | 注射用紫杉醇 白蛋白结合型 |
通用外文 | paclitaxel protein-bound |
品牌中文 | |
品牌外文 | Abraxane |
其他名称 | |
公司 | 新基(Celgene) |
产地 | 德国(Germany) |
含量 | 100mg |
包装 | 1瓶/盒 |
剂型给药 | |
储存 | 室温 |
适用范围 | 非小细胞肺癌一线治疗转移性胰腺癌和乳腺癌。包括黑色素瘤、膀胱癌、卵巢癌以及乳腺癌、肺癌的。 |
【注射用紫杉醇(白蛋白结合型)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。
【注射用紫杉醇(白蛋白结合型)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。
注射用紫杉醇(白蛋白结合型)给药前不需给予患者抗过敏药预处理。
【注射用紫杉醇(白蛋白结合型)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。
【注射用紫杉醇(白蛋白结合型)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。
【注射用紫杉醇(白蛋白结合型)性状】
注射用紫杉醇(白蛋白结合型)为无色或淡黄色澄明粘稠液体。
【注射用紫杉醇(白蛋白结合型)生产企业】
公司名称:CelgeneCorporation
公司地址:86MorrisAve,Summit,NJ07901,USA
生产厂商:FreseniusKabiUSA,LLC
厂商地址:MelrosePark,IL60160,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.